Orthopediatrics Corp
Warsaw, IN, US
ORTHOPEDIATRICS, CORP appears in FDA device records in Warsaw, IN. FDA records list 44 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 52 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 44 510(k) clearances for Orthopediatrics Corp between 2008 and 2026. The busiest year on record is 2025, with 6. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 5 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 6 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | HRS | Substantially Equivalent | |
| K252600 | Pediatric Plating Platform I Small-Mini | HRS | Substantially Equivalent | |
| K251362 | PediFlex™ Flexible Nail System | HTY | Substantially Equivalent | |
| K243963 | Pediatric Plating Platform Hip | HRS | Substantially Equivalent | |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | HSB | Substantially Equivalent | |
| K241816 | VerteGlide Spinal Growth Guidance System | PGM | Substantially Equivalent | |
| K243798 | Orthex External Fixation System | KTT | Substantially Equivalent | |
| K233105 | RESPONSE™ Rib and Pelvic System | MDI | Substantially Equivalent | |
| K231266 | Pediatric Nailing Platform Tibia | HSB | Substantially Equivalent | |
| K222105 | RESPONSE 5.5/6.0 Cannulated Screw System | NKB | Substantially Equivalent | |
| K223786 | Orthex External Fixation System | KTT | Substantially Equivalent | |
| K220679 | Pediatric Nailing Platform Femur | HSB | Substantially Equivalent | |
| K220809 | Drive Rail System | KTT | Substantially Equivalent | |
| K203573 | RESPONSE Navigation Instruments | OLO | Substantially Equivalent | |
| K201838 | PediFlex Flexible Nail System | HTY | Substantially Equivalent | |
| K193100 | RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System | NKB | Substantially Equivalent | |
| K200097 | Response BandLoc Spinal Fixation | OWI | Substantially Equivalent | |
| K190321 | Pediatric Nailing PlatformFemur | HSB | Substantially Equivalent | |
| K190992 | OrthoPediatrics PediFoot Deformity Corrections System | HRS | Substantially Equivalent | |
| K190324 | OrthoPediatrics Cannulated Screw System | HWC | Substantially Equivalent | |
| K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System | NKB | Substantially Equivalent | |
| K172583 | OrthoPediatrics PediNail Intramedullary Platform | HSB | Substantially Equivalent | |
| K172425 | OrthoPediatrics Wrist Fusion Plate | HRS | Substantially Equivalent | |
| K171173 | OrthoPediatrics Titanium PediPlates® System | HRS | Substantially Equivalent | |
| K162307 | OrthoPediatrics Locking Proximal Femur System Cortical Screws | HRS | Substantially Equivalent | |
| K161267 | Response BandLoc Spinal Fixation | OWI | Substantially Equivalent | |
| K160466 | Response 5.5 Spine System | NKB | Substantially Equivalent | |
| K150600 | Response 5.5/6.0 Spine System | NKB | Substantially Equivalent | |
| K140431 | PEDILOC FRAGMENT SYSTEM | HRS | Substantially Equivalent | |
| K130217 | ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM | MBI | Substantially Equivalent | |
| K130655 | RESPONSE SPINE SYSTEM | OSH | Substantially Equivalent | |
| K121250 | OP SPINE SYSTEM | OSH | Unknown | |
| K120291 | OP SPINE SYSTEM | OSH | Unknown | |
| K110959 | ORTHOPEDIATRICS BLADE PLATE SYSTEM | HRS | Substantially Equivalent | |
| K111086 | ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM | HRS | Substantially Equivalent | |
| K100240 | ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM | HRS | Substantially Equivalent | |
| K090666 | PEDIPLATES | HRS | Substantially Equivalent | |
| K083726 | PEDINAIL INTRAMEDULLARY NAILING SYSTEM | HSB | Substantially Equivalent | |
| K083286 | ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM | HRS | Substantially Equivalent | |
| K082949 | ORTHOPEDIATRICS BONE SCREWS | HWC | Substantially Equivalent | |
| K082375 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM | HTY | Substantially Equivalent | |
| K081407 | ORTHOPEDIATRICS PEDIPLATES SYSTEM | HRS | Substantially Equivalent | |
| K081097 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM | HTY | Substantially Equivalent | |
| K073344 | ORTHOPEDIATRICS PLATING SYSTEM | HRS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006460162 | 3006460162 | ORTHOPEDIATRICS, CORP | 2850 Frontier Dr, Warsaw, IN 46582 US | 2026 | and 54 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWPAppliance, Fixation, Spinal Interlaminal
- HWJAwl
- HXWBender
- HTWBit, Drill
- GFGBit, Surgical
- FZOChisel, Surgical, Manual
- HXDClamp
- FZTCutter, Surgical
- HXZCutter, Wire
- JDODevice, Fixation, Proximal Femoral, Implant
- GFCDriver, Surgical, Pin
- GEGElevator, Surgical, General & Plastic Surgery
- HWBExtractor
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- HTPFile
- HTDForceps
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- KIKHook, Bone
- HWAImpactor
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- KDDKit, Surgical Instrument, Disposable
- HXLMallet
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- IQIOrthosis, Limb Brace
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HWMOsteotome
- HWQPasser
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- HTYPin, Fixation, Smooth
- JDWPin, Fixation, Threaded
- OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis
- HRSPlate, Fixation, Bone
- HXBProbe
- MDIProsthesis, Rib Replacement
- HTHProtractor
- LRYPunch, Surgical
- HTRRasp
- HTOReamer
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- JDRStaple, Fixation, Bone
- GAHStylet, Surgical, General & Plastic Surgery
- JEBTable, Surgical With Orthopedic Accessories, Manual
- HXGTamp
- HWXTap, Bone
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
- HXCWrench
Recall records
Showing 25 of 52| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0277-2023 | Orthex Large Bone Shoulder Bolt, model no. AS-17 | Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration. | Class II | Open, Classified | |
| Z-1678-2022 | Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN | Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time | Class II | Open, Classified | |
| Z-2742-2020 | Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease Model Number: 00-1300-6053 | Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device | Class II | Open, Classified | |
| Z-2539-2020 | OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction. | ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package. | Class II | Terminated | |
| Z-2538-2020 | OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction. | ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package. | Class II | Terminated | |
| Z-0219-2020 | Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system. | Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. | Class II | Terminated | |
| Z-0218-2020 | Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system. | Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. | Class II | Terminated | |
| Z-0125-2020 | OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032 | Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures | Class II | Terminated | |
| Z-0597-2018 | Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation | The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws. | Class II | Terminated | |
| Z-2321-2017 | Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening. | Over-tensioning of the band resulting in damage to the band causing it to rupture | Class II | Terminated | |
| Z-0879-2017 | OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw | Labeled as a 48mm Cortical Screw but measuring at 50mm | Class III | Terminated | |
| Z-2844-2016 | 3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction. | OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled. | Class II | Terminated | |
| Z-2843-2016 | 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction. | OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled. | Class II | Terminated | |
| Z-0622-2016 | UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. | Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw. | Class II | Terminated | |
| Z-2796-2015 | 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics. | The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly. | Class II | Terminated | |
| Z-2560-2014 | ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone. | Weld fractures on the Sleeve Installation Tool for ACL reconstruction system. | Class II | Terminated | |
| Z-0934-2014 | 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system. | OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524. | Class II | Terminated | |
| Z-0579-2014 | OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery. | Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size. | Class II | Terminated | |
| Z-0276-2014 | 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system. | The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics. | Class II | Terminated | |
| Z-1941-2013 | 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw. | OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has | Class II | Terminated | |
| Z-1536-2013 | 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies. | Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively. | Class II | Terminated | |
| Z-1535-2013 | 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies. | Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively. | Class II | Terminated | |
| Z-1534-2013 | 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies. | Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively. | Class II | Terminated | |
| Z-0432-2013 | 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc system. The PediLoc Extension Osteotomy Plate consists of 3.5mm and 4.5mm plates, left and right side specific. The PediLoc Extension Osteotomy Plate is designed to fit the anatomy of the distal femur in children and adolescents, above the distal femoral physis. The distal section of the plate is designed so that three locking screws can be placed in the distal bone segment at an angle parallel to the distal femoral physis. The proximal portion of the plate is designed to accept locking or non-locking screws. The subject instrument of this recall is an adjunct instrument for the convenience of some surgeons who choose to use it. This instrument is not illustrated in the Surgical Technique, nor required to perform the procedure. | Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended. | Class II | Terminated | |
| Z-0207-2013 | Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. | A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain