Howmedica Osteonics Corp., dba Stryker Orthopaedics
Mahwah, NJ, US
Howmedica Osteonics Corp., Dba Stryker Orthopaedics appears in FDA device records in Mahwah, NJ. FDA records list 33 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 33
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 33 510(k) clearances for Howmedica Osteonics Corp., dba Stryker Orthopaedics between 2010 and 2026. The busiest year on record is 2025, with 6. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 2 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 4 |
| 2023 | 5 |
| 2024 | 5 |
| 2025 | 6 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | KRO | Substantially Equivalent | |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component | LPH | Substantially Equivalent | |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | MBH | Substantially Equivalent | |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper | KRO | Substantially Equivalent | |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | MBH | Substantially Equivalent | |
| K251665 | Triathlon® Hinge Knee System | KRO | Substantially Equivalent | |
| K250989 | Stryker and Serf hip devices | LPH | Substantially Equivalent | |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert | JWH | Substantially Equivalent | |
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | LPH | Substantially Equivalent | |
| K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System | JWH | Substantially Equivalent | |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | JDI | Substantially Equivalent | |
| K234025 | 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads | LZO | Substantially Equivalent | |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | JDI | Substantially Equivalent | |
| K233724 | 28mm/38D MDM X3 Insert for MDM Liner | LZO | Substantially Equivalent | |
| K233498 | Stryker Orthopaedics Hip Systems Labeling Update | LPH | Substantially Equivalent | |
| K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component | JWH | Substantially Equivalent | |
| K223069 | Modular Rotating Hinge Knee Systems and Compatible Components | KRO | Substantially Equivalent | |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | JDI | Substantially Equivalent | |
| K223528 | Triathlon® Hinge Knee System | KRO | Substantially Equivalent | |
| K222632 | UHR Bipolar Implants, Restoration GAP II Implants | KWL | Substantially Equivalent | |
| K220376 | Acetabular Dome Hole Plug | LPH | Substantially Equivalent | |
| K212187 | Restoration® Modular Hip System | LPH | Substantially Equivalent | |
| K213701 | Exeter® X3® RimFit® Cup | JDI | Substantially Equivalent | |
| K213129 | Restoration Modular 115mm Conical Distal Stem | LZO | Substantially Equivalent | |
| K211303 | Avon Patello-femoral Joint Prosthesis | KRR | Substantially Equivalent | |
| K202016 | Dall-Miles® Cable System | JDQ | Substantially Equivalent | |
| K201343 | Triathlon Total KneeSystem | JWH | Substantially Equivalent | |
| K122308 | AXSOS DISTAL LATERAL FEMUR TS LONG PLATES | HRS | Substantially Equivalent | |
| K113760 | VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK | HRS | Substantially Equivalent | |
| K112455 | AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES | HRS | Substantially Equivalent | |
| K110176 | AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS | HRS | Substantially Equivalent | |
| K102282 | THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES | HRS | Substantially Equivalent | |
| K103010 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | KKY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JDQCerclage, Fixation
- KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- HRSPlate, Fixation, Bone
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- 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
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Howmedica Osteonics Corp., dba Stryker Orthopaedics edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Howmedica Osteonics Corp., dba Stryker Orthopaedics. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain