Howmedica Osteonics Corp
Mahwah, NJ, US
HOWMEDICA OSTEONICS CORP appears in FDA device records in Mahwah, NJ. FDA records list 377 510(k) clearances between and , 48 PMA records and 3 registered establishments. As of , FDA records show 862 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Howmedica Osteonics Corp carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Stryker Howmedica Osteonics510(k), enforcement report, recall
- Stryker Spineregistration, 510(k), PMA, enforcement report, recall
510(k) clearance history
Showing 50 of 377FDA records hold 377 510(k) clearances for Howmedica Osteonics Corp between 1999 and 2026. The busiest year on record is 2005, with 40. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 27 |
| 2000 | 37 |
| 2001 | 29 |
| 2002 | 37 |
| 2003 | 32 |
| 2004 | 27 |
| 2005 | 40 |
| 2006 | 36 |
| 2007 | 22 |
| 2008 | 18 |
| 2009 | 14 |
| 2010 | 16 |
| 2011 | 8 |
| 2012 | 11 |
| 2013 | 7 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 3 |
| 2021 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM | ODP | Substantially Equivalent | |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute | MQV | Substantially Equivalent | |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI | KWQ | Substantially Equivalent | |
| K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips | MQV | Substantially Equivalent | |
| K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi | NKB | Substantially Equivalent | |
| K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer | ODP | Substantially Equivalent | |
| K203205 | Navigated Spine Instruments | OLO | Substantially Equivalent | |
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | JDI | Substantially Equivalent | |
| K200782 | Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite | MBH | Substantially Equivalent | |
| K200666 | Stryker Xia 3 Power Adaptor | NKB | Substantially Equivalent | |
| K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage | MAX | Substantially Equivalent | |
| K183071 | VLIFT-s Vertebral Body Replacement System | PLR | Substantially Equivalent | |
| K181014 | Tritanium PL Cage | MAX | Substantially Equivalent | |
| K171496 | Tritanium C Anterior Cervical Cage | ODP | Substantially Equivalent | |
| K161407 | Ascential IBD PEEKc Spacer | ODP | Substantially Equivalent | |
| K152532 | AERO -C Cervical Cage System | ODP | Substantially Equivalent | |
| K130895 | REUNION RSA SHOULDER SYSTEM | PHX | Substantially Equivalent | |
| K133188 | MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL | NKB | Substantially Equivalent | |
| K132968 | UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) | PEK | Substantially Equivalent | |
| K123604 | ABG III MONOLITHIC HIP STEM | MAY | Substantially Equivalent | |
| K122015 | DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE | KRO | Substantially Equivalent | |
| K123166 | TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P | JWH | Substantially Equivalent | |
| K122853 | NOVEL FIT AND FILL STEM | MEH | Substantially Equivalent | |
| K122845 | ES2 SPINAL SYSTEM MODEL 48280XXXX | NKB | Substantially Equivalent | |
| K122637 | LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 | FST | Substantially Equivalent | |
| K121315 | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT | FWP | Substantially Equivalent | |
| K120869 | ANCHOR-L LUMBAR CAGE | OVD | Substantially Equivalent | |
| K113666 | XIA 3 SPINAL SYSTEM | NKB | Unknown | |
| K120486 | AVS AS PEEK SPACER | ODP | Substantially Equivalent | |
| K121308 | HIP SYSTEMS | LPH | Substantially Equivalent | |
| K113802 | ESCALATE LAMINOPLASTY SYSTEM | NQW | Substantially Equivalent | |
| K120578 | ACCOLADE II HIP STEM | JDI | Substantially Equivalent | |
| K113409 | S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL | HSB | Substantially Equivalent | |
| K111719 | OASYS SPINAL SYSTEM | KWP | Substantially Equivalent | |
| K112556 | ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS | MEH | Substantially Equivalent | |
| K110290 | EXETER HIP STEM | JDI | Substantially Equivalent | |
| K110419 | AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS | GXZ | Substantially Equivalent | |
| K103835 | REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N | KWS | Substantially Equivalent | |
| K102606 | AVS ANCHOR-C CERVICAL CAGE SYSTEM | OVE | Substantially Equivalent | |
| K101072 | TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE | LPH | Substantially Equivalent | |
| K102019 | RESTORATION ACETABULAR WEDGE AUGMENTS | LPH | Substantially Equivalent | |
| K103233 | MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT | LZO | Substantially Equivalent | |
| K102992 | T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES | HSB | Substantially Equivalent | |
| K103104 | SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT | KWS | Substantially Equivalent | |
| K101183 | MODIFICATION TO: OASYS SYSTEM | KWP | Substantially Equivalent | |
| K102235 | MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K101051 | AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX | MAX | Substantially Equivalent | |
| K100865 | AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX | MAX | Substantially Equivalent | |
| K101144 | MODIFICATION TO:RADIUS SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K100884 | STRYKER KNIFELIGHT | FTD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2249697 | 3003070421 | HOWMEDICA OSTEONICS CORP | 325 CORPORATE DR., MAHWAH, NJ 07430 US | 2026 | and 54 more, listed in full below |
| 3004024955 | 3004024955 | STRYKER SPINE | 2 PEARL COURT, ALLENDALE, NJ 07401 US | 2026 | and 26 more, listed in full below |
| 9617544 | 3003112432 | STRYKER SPINE | ZONE INDUSTRIELLE DE MARTICOT, CESTAS Nouvelle-Aquitaine 33610 FR | 2026 | and 15 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
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component
- HWJAwl
- HTWBit, Drill
- JDQCerclage, Fixation
- FZOChisel, Surgical, Manual
- HXDClamp
- JECComponent, Traction, Invasive
- HTFCurette
- HWRDriver, Prosthesis
- GXZElectrode, Needle
- GEGElevator, Surgical, General & Plastic Surgery
- HWBExtractor
- HTDForceps
- HTJGauge, Depth
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- HWAImpactor
- KNWInstrument, Biopsy
- HTZInstrument, Cutting, Orthopedic
- HAOInstrument, Surgical, Non-Powered
- FTDLamp, Surgical
- FSTLight, Surgical, Fiberoptic
- KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis
- JDSNail, Fixation, Bone
- HAWNeurological Stereotaxic Instrument
- HXIPasser, Wire, Orthopedic
- HTYPin, Fixation, Smooth
- JDWPin, Fixation, Threaded
- GWOPlate, Cranioplasty, Preformed, Alterable
- HRSPlate, Fixation, Bone
- FWPProsthesis, Chin, Internal
- JDCProsthesis, Elbow, Constrained, Cemented
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer
- JDKProsthesis, Hip, Cement Restrictor
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- HTOReamer
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- JDRStaple, Fixation, Bone
- ETNStimulator, Nerve
- FMFSyringe, Piston
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
Showing 25 of 862| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2462-2026 | TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400. | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB). | Class II | Open, Classified | |
| Z-2461-2026 | TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB). | Class II | Open, Classified | |
| Z-1572-2026 | MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 | A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment. | Class II | Open, Classified | |
| Z-0963-2026 | The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration. | When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device. | Class II | Open, Classified | |
| Z-2640-2025 | 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352; | a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted. | Class II | Open, Classified | |
| Z-1491-2025 | Monterey AL Implant Inserter; 22mm; Catalog 48019140. | Potential for the gold unlock button to separate from the inserter. | Class II | Open, Classified | |
| Z-1490-2025 | Monterey AL Implant Inserter; 18/20mm; Catalog 48019130. | Potential for the gold unlock button to separate from the inserter. | Class II | Open, Classified | |
| Z-1489-2025 | Monterey AL Implant Inserter; 14/16mm; Catalog 48019120. | Potential for the gold unlock button to separate from the inserter. | Class II | Open, Classified | |
| Z-1488-2025 | Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. | Potential for the gold unlock button to separate from the inserter. | Class II | Open, Classified | |
| Z-0023-2025 | Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200 | Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert. | Class II | Open, Classified | |
| Z-3210-2024 | AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. | Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed. | Class II | Open, Classified | |
| Z-0044-2025 | MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 | Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces. | Class II | Open, Classified | |
| Z-2732-2024 | Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00; | A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal. | Class II | Open, Classified | |
| Z-2372-2024 | UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038 | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm) | Class II | Open, Classified | |
| Z-2371-2024 | UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042 | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm) | Class II | Open, Classified | |
| Z-2370-2024 | UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043 | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm) | Class II | Open, Classified | |
| Z-2153-2024 | Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910 | The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments. | Class II | Open, Classified | |
| Z-2152-2024 | HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 | The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments. | Class II | Open, Classified | |
| Z-1632-2024 | TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | Class II | Open, Classified | |
| Z-1631-2024 | TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | Class II | Open, Classified | |
| Z-1630-2024 | TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | Class II | Open, Classified | |
| Z-1629-2024 | TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | Class II | Open, Classified | |
| Z-1628-2024 | TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | Class II | Open, Classified | |
| Z-1627-2024 | TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | Class II | Open, Classified | |
| Z-1626-2024 | TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain