Company · US
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2026. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (4 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 6 |
| HRS | Plate, Fixation, Bone | 5 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 5 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 4 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 4 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 |
| JDQ | Cerclage, Fixation | 1 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 1 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 |
| LZN | Cement Obturator | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 6, 2026 | K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System Howmedica Osteonics Corp. dba Stryker Orthopaedics | KRO |
| Jul 10, 2026 | K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH |
| Feb 18, 2026 | K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert Howmedica Osteonics Corp., Dba Stryker Orthopaedics | MBH |
| Dec 15, 2025 | K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathl Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KRO |
| Oct 24, 2025 | K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components Howmedica Osteonics Corp., Dba Stryker Orthopaedics | MBH |
| Jul 25, 2025 | K251665 | Triathlon® Hinge Knee System Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KRO |
| Jul 25, 2025 | K250989 | Stryker and Serf hip devices Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | LPH |
| Feb 6, 2025 | K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpi Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JWH |
| Feb 6, 2025 | K243784 | Stryker Orthopaedics Hip Devices Labeling Update Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH |
| Dec 4, 2024 | K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Tria Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JWH |
| Aug 2, 2024 | K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JDI |
| Apr 24, 2024 | K234025 | 22.2mm BIOLOX® delta Ceramic V40 Femoral Heads Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LZO |
| Apr 12, 2024 | K240418 | Stryker Orthopaedics Hip Systems Labeling Update Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JDI |
| Mar 11, 2024 | K233724 | 28mm/38D MDM X3 Insert for MDM Liner Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LZO |
| Dec 21, 2023 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH |
| Jun 2, 2023 | K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JWH |
| Apr 21, 2023 | K223069 | Modular Rotating Hinge Knee Systems and Compatible Components Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KRO |
| Jan 26, 2023 | K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JDI |
| Jan 20, 2023 | K223528 | Triathlon® Hinge Knee System Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KRO |
| Oct 21, 2022 | K222632 | UHR Bipolar Implants, Restoration GAP II Implants Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KWL |
| May 20, 2022 | K220838 | Artisan Bone Plug, Universal Cement Restrictor Howmedica Osteonics, Dba Stryker Orthopaedics | LZN |
| Mar 9, 2022 | K220376 | Acetabular Dome Hole Plug Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH |
| Mar 1, 2022 | K212187 | Restoration® Modular Hip System Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH |
| Feb 1, 2022 | K213701 | Exeter® X3® RimFit® Cup Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JDI |
| Dec 21, 2021 | K213129 | Restoration Modular 115mm Conical Distal Stem Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LZO |
| Jun 4, 2021 | K211303 | Avon Patello-femoral Joint Prosthesis Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KRR |
| Oct 16, 2020 | K202016 | Dall-Miles® Cable System Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JDQ |
| Jul 10, 2020 | K201343 | Triathlon Total KneeSystem Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JWH |
| Oct 1, 2012 | K122308 | AXSOS DISTAL LATERAL FEMUR TS LONG PLATES Howmedica Osteonics Corp., Dba Stryker Orthopaedics | HRS |
| Apr 25, 2012 | K113760 | VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK Howmedica Osteonics Corp., Dba Stryker Orthopaedics | HRS |
| Sep 22, 2011 | K112455 | AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES Howmedica Osteonics Corp., Dba Stryker Orthopaedics | HRS |
| Feb 15, 2011 | K110176 | AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS Howmedica Osteonics Corp., Dba Stryker Orthopaedics | HRS |
| Dec 7, 2010 | K102282 | THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES Howmedica Osteonics Corp., Dba Stryker Orthopaedics | HRS |
| Oct 26, 2010 | K103010 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KKY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||