Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

91 daysmedian FDA review time
190 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K233261Global Modular Replacement SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2023-12-08700
K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2021-04-22280
K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2020-10-27130
K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2019-10-241560
K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular InsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2019-03-191900
K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2018-06-07910
K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2017-11-16767
K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2017-10-0211012
K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low ProfHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2016-10-141290

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