Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Howmedica Osteonics Corp. dba Stryker Orthopaedics · Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
126 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpi | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 2026-08-06 | 62 | 0 |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-07-10 | 56 | 0 |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabili | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-02-18 | 91 | 0 |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritani | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-12-15 | 95 | 0 |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Compo | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-10-24 | 116 | 0 |
| K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025-07-25 | 116 | 0 |
| K251665 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-07-25 | 56 | 0 |
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-02-06 | 59 | 0 |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Ins | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-02-06 | 56 | 0 |
| K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Fe | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-12-04 | 76 | 0 |
| K241716 | Global Modular Replacement System, Modular Replacement Syste | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-08-02 | 49 | 0 |
| K234025 | 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-24 | 126 | 0 |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-12 | 59 | 0 |
| K233724 | 28mm/38D MDM X3 Insert for MDM Liner | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-03-11 | 111 | 0 |
| K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-12-21 | 51 | 0 |
| K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stab | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-06-02 | 59 | 0 |
| K223069 | Modular Rotating Hinge Knee Systems and Compatible Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-04-21 | 203 | 0 |
| K222056 | Global Modular Replacement System, Modular Replacement Syste | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-01-26 | 198 | 1 |
| K223528 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-01-20 | 58 | 0 |
| K222632 | UHR Bipolar Implants, Restoration GAP II Implants | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-10-21 | 51 | 0 |
| K220376 | Acetabular Dome Hole Plug | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-03-09 | 27 | 0 |
| K212187 | Restoration® Modular Hip System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-03-01 | 231 | 0 |
| K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-02-01 | 69 | 0 |
| K213129 | Restoration Modular 115mm Conical Distal Stem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2021-12-21 | 85 | 0 |
| K211303 | Avon Patello-femoral Joint Prosthesis | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2021-06-04 | 36 | 0 |
| K202016 | Dall-Miles® Cable System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020-10-16 | 87 | 0 |
| K201343 | Triathlon Total KneeSystem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020-07-10 | 51 | 0 |
| K122308 | AXSOS DISTAL LATERAL FEMUR TS LONG PLATES | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012-10-01 | 61 | 0 |
| K113760 | VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012-04-25 | 126 | 0 |
| K112455 | AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2011-09-22 | 28 | 0 |
| K110176 | AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2011-02-15 | 25 | 0 |
| K102282 | THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITI | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010-12-07 | 117 | 0 |
| K103010 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010-10-26 | 14 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda