Ortho Development Corp.
Draper, UT, US
ORTHO DEVELOPMENT CORP. appears in FDA device records in Draper, UT. FDA records list 64 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 28 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 64FDA records hold 64 510(k) clearances for Ortho Development Corp. between 1996 and 2025. The busiest year on record is 1997, with 5. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 4 |
| 1997 | 5 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2005 | 5 |
| 2006 | 5 |
| 2007 | 3 |
| 2009 | 1 |
| 2011 | 4 |
| 2013 | 5 |
| 2014 | 5 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 4 |
| 2020 | 1 |
| 2021 | 3 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253161 | Balanced Knee System TriMax Porous Femoral Components | MBH | Substantially Equivalent | |
| K251052 | Trivicta® Hip Stem | MEH | Substantially Equivalent | |
| K242984 | BKS Revision System | JWH | Substantially Equivalent | |
| K242833 | Legend® Acetabular Shell | LPH | Substantially Equivalent | |
| K233758 | Trivicta™ Hip Stem | MEH | Substantially Equivalent | |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert | JWH | Substantially Equivalent | |
| K211086 | The Progen™ Trochanteric Nail System | HSB | Substantially Equivalent | |
| K211471 | Balanced Knee System Uni | HSX | Substantially Equivalent | |
| K203023 | Pisces Spinal System | NKB | Substantially Equivalent | |
| K200281 | The Gecko Spinal System | OWI | Substantially Equivalent | |
| K182085 | Balanced Knee Revision System Trabecular Tibial Cone Augments | JWH | Substantially Equivalent | |
| K181569 | BKS Revision Sleeves System | JWH | Substantially Equivalent | |
| K180743 | Balanced Knee Revision System - Offset Junction Box | JWH | Substantially Equivalent | |
| K173951 | Legend Acetabular Liners | LPH | Substantially Equivalent | |
| K171249 | Entrada™ hip stem | MEH | Substantially Equivalent | |
| K162995 | Ibis® Pedicle Screw System | NKB | Substantially Equivalent | |
| K161080 | Escalade Legend Acetabular Shell | LPH | Substantially Equivalent | |
| K153216 | Alpine Cemented Hip System | JDI | Substantially Equivalent | |
| K152169 | Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts | JWH | Substantially Equivalent | |
| K142146 | IBIS PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K141001 | ALPINE HIP STEM; ALPINE HA HIP STEM | LPH | Substantially Equivalent | |
| K132697 | ENCOMPASS 10/12 HIP STEM | LPH | Substantially Equivalent | |
| K133386 | OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM | LPH | Substantially Equivalent | |
| K133449 | KASM KNEE ARTICULATING SPACER MOLDS | JWH | Substantially Equivalent | |
| K131022 | OVATION 10/12 HIP STEM | LPH | Substantially Equivalent | |
| K131337 | BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA | JWH | Substantially Equivalent | |
| K131785 | PAGODA PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K122588 | VUSION CS PLUS | ODP | Substantially Equivalent | |
| K123457 | BALANCED KNEE SYSTEM HIGH FLEX PS | JWH | Substantially Equivalent | |
| K111965 | VUSION(R) OS | MAX | Substantially Equivalent | |
| K111936 | ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD | LZO | Substantially Equivalent | |
| K103837 | BALANCED KNEE SYSTEM REVISION OFFSET TIBIA | JWH | Substantially Equivalent | |
| K103384 | ESCALADE ACETABULAR CUP SYSTEM | LPH | Substantially Equivalent | |
| K090705 | BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT | JWH | Substantially Equivalent | |
| K062171 | EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES | GEI | Substantially Equivalent | |
| K062666 | VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS | MQP | Substantially Equivalent | |
| K062775 | EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM | LPH | Substantially Equivalent | |
| K061524 | ISS INTEGRATED SPINE SYSTEM | MNH | Substantially Equivalent | |
| K060569 | BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM | JWH | Substantially Equivalent | |
| K060577 | ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | |
| K053587 | ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS | LZO | Substantially Equivalent | |
| K053293 | ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS | LPH | Substantially Equivalent | |
| K050637 | ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS | JDI | Substantially Equivalent | |
| K051407 | LEGEND ALL-POLY CUP | JDI | Substantially Equivalent | |
| K050966 | PIVOT BIPOLAR FEMORAL HEAD | KWY | Substantially Equivalent | |
| K042565 | ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER | LPH | Substantially Equivalent | |
| K042973 | SOLITUDE UNIPOLAR HEAD | KWL | Substantially Equivalent | |
| K031201 | ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM | JWH | Substantially Equivalent | |
| K020383 | ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED | JWH | Substantially Equivalent | |
| K020649 | ENVISION ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1722511 | 1000143502 | ORTHO DEVELOPMENT CORP. | 12187 SOUTH BUSINESS PARK DR., DRAPER, UT 84020 US | 2026 | and 44 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HXWBender
- HTWBit, Drill
- MBBBone Cement, Antibiotic
- OWIBone Fixation Cerclage, Sublaminar
- HTQBroach
- HXDClamp
- FZSCurette, Surgical, General Use
- FZTCutter, Surgical
- HWRDriver, Prosthesis
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HWBExtractor
- HTDForceps
- LXZGuard, Instrument
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- GDZHandle, Scalpel
- HWAImpactor
- KNWInstrument, Biopsy
- HWNInstrument, Compression
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- HXLMallet
- JDSNail, Fixation, Bone
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HXIPasser, Wire, Orthopedic
- HRSPlate, Fixation, Bone
- HXBProbe
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- LRYPunch, Surgical
- HTOReamer
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- MQPSpinal Vertebral Body Replacement Device
- HWXTap, Bone
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
Recall records
Showing 25 of 28| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1904-2020 | Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V. | The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled. | Class II | Open, Classified | |
| Z-1903-2020 | Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V. | The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled. | Class II | Open, Classified | |
| Z-2257-2014 | Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed | Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. | Class II | Terminated | |
| Z-2256-2014 | Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component | Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. | Class II | Terminated | |
| Z-2255-2014 | PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component | Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. | Class II | Terminated | |
| Z-2254-2014 | Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component | Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. | Class II | Terminated | |
| Z-2253-2014 | Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum | Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. | Class II | Terminated | |
| Z-1610-2014 | PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures. | A femoral component containing pegs was found in a box for the pegless version. | Class II | Terminated | |
| Z-0740-2012 | U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is included in Part Number 270-9004-Escalade Acetabular Prep Kit and Part Number 228-9001-Triplus Acetabular Instrument Kit. The Acetabular Cup System is indicated for use in total hip arthroplasty procedures where the means of cup fixation is uncemented, biological fixation. The Hex Head Drive is used to place the screw that affixes the acetabular cup to the hip acetabulum. | Tip of hex-head screwdriver may break off during use in hip replacement procedure. | Terminated | ||
| Z-2603-2011 | Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho Development, Draper, Utah 84020. Intended for use in total hip arthroscopy. Device fixation is achieved by an optimal, press-fit in the medullary canal, which maximizes contact between the stem and the bone. | Tests on PVC packaging material resulted in alert levels for cytotoxicity. | Terminated | ||
| Z-2602-2011 | Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R, Ortho Development, Draper, Utah 84020. Intended for use in total hip arthroscopy. Device fixation is achieved by an optimal, press-fit in the medullary canal, which maximizes contact between the stem and the bone. | Tests on PVC packaging material resulted in alert levels for cytotoxicity. | Terminated | ||
| Z-1673-2011 | Ovation Hip Stem, REF 201-0104, Offset Stem Inserter Neutral, Non-Sterile, Ortho Development, Draper, Utah 84020. The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an instrument used to seat the hip stem in the femur. There is a notch in the top of the hip stem, and the hip stem inserter has a corresponding tip at the end of the instrument. The tip of the inserter is designed to fit into the notch of the hip stem, as a guide. Once this is inserted, the surgeon will tap on the opposite end of the inserter with a hammer to seat the press-fitted stem assembly. | Component of total hip arthroplasty may break during surgical procedure. | Terminated | ||
| Z-1672-2011 | Ovation Hip Stem, REF 201-0103, Offset Stem Inserter LT, Non-Sterile, Ortho Development, Draper, Utah 84020. The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an instrument used to seat the hip stem in the femur. There is a notch in the top of the hip stem, and the hip stem inserter has a corresponding tip at the end of the instrument. The tip of the inserter is designed to fit into the notch of the hip stem, as a guide. Once this is inserted, the surgeon will tap on the opposite end of the inserter with a hammer to seat the press-fitted stem assembly. | Component of total hip arthroplasty may break during surgical procedure. | Terminated | ||
| Z-1671-2011 | Ovation Hip Stem, REF 201-0102, Offset Stem Inserter RT, Non-Sterile, Ortho Development, Draper, Utah 84020. The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an instrument used to seat the hip stem in the femur. There is a notch in the top of the hip stem, and the hip stem inserter has a corresponding tip at the end of the instrument. The tip of the inserter is designed to fit into the notch of the hip stem, as a guide. Once this is inserted, the surgeon will tap on the opposite end of the inserter with a hammer to seat the press-fitted stem assembly. | Component of total hip arthroplasty may break during surgical procedure. | Terminated | ||
| Z-1670-2011 | Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development, Draper, Utah 84020. The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an instrument used to seat the hip stem in the femur. There is a notch in the top of the hip stem, and the hip stem inserter has a corresponding tip at the end of the instrument. The tip of the inserter is designed to fit into the notch of the hip stem, as a guide. Once this is inserted, the surgeon will tap on the opposite end of the inserter with a hammer to seat the press-fitted stem assembly. | Component of total hip arthroplasty may break during surgical procedure. | Terminated | ||
| Z-1742-2011 | UC Tibial Insert, Size 4, 12mm, REF 163-3412, Sterile R, Ortho Development, Draper, Utah 84020 The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure. | Components of a replacement knee system could be mislabeled. | Terminated | ||
| Z-1741-2011 | CR Tibial Insert, Size 5, 7mm, REF 163-2507, Sterile R, Ortho Development, Draper, Utah 84020. The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure. | Components of a replacement knee system could be mislabeled. | Terminated | ||
| Z-1740-2011 | UC Tibial Insert, Size 4, 13mm, REF 163-3413, Sterile R, Ortho Development, Draper, Utah 84020. The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure. | Components of a replacement knee system could be mislabeled. | Terminated | ||
| Z-0315-2011 | Distal Centralizer 10 mm | The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper. | Terminated | ||
| Z-1993-2009 | Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020. The Balanced Knee System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral stability. | Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were mixed in with the recalled lot (0054891). | Terminated | ||
| Z-0086-2010 | Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head. | A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances. | Terminated | ||
| Z-1229-2010 | 5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from severe knee pain and disability. The indications for use are: 1) loss of joint configuration and joint function, 2) Osteoarthritis of the knee joint, 3) Rheumatoid arthritis of the knee joint, 4) Post-traumatic arthritis of the knee joint, 5) Moderate valgus, varus, or flexion deformities and 6) Revision procedures where other treatments or devices have failed. | A component of knee prosthesis was assembled incorrectly. | Terminated | ||
| Z-1228-2010 | 10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular Tibial System. The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from severe knee pain and disability. The indications for use are: 1) loss of joint configuration and joint function, 2) Osteoarthritis of the knee joint, 3) Rheumatoid arthritis of the knee joint, 4) Post-traumatic arthritis of the knee joint, 5) Moderate valgus, varus, or flexion deformities and 6) Revision procedures where other treatments or devices have failed. | A component of knee prosthesis was assembled incorrectly. | Terminated | ||
| Z-0042-04 | Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System. | The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out. | Terminated | ||
| Z-0569-03 | Hip Prosthesis as a component of TriFix J Cemented Hip. (Manufactured for distribution in Japan only.) | Cleaning agent residue from packaging material was adhering to implantable hip stems. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain