Triathlon PKR System— 510(k) K203099

Clearance details

Applicant

Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

Product code

Code HSX

Device class

Class 2

Regulation

21 CFR 888.3520

Advisory panel

Orthopedic

Date received

2020-10-14

Decision date

2020-10-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mahwah, NJ, US

• K261609 — Freedom Partial Knee System2026-08-04
• K260796 — Tahoe Unicondylar Knee System with TiNbN Overcoat2026-04-02
• K251771 — Cambridge Partial Knee2025-12-16
• K251834 — Persona Partial Knee2025-08-15
• K251618 — MOTO Partial Knee System Extension2025-07-24

• K233261 — Global Modular Replacement System2023-12-08
• K210893 — Restoration Anatomic Shell2021-04-22
• K191358 — Trident II Acetabular System2019-10-24
• K182468 — Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System2019-03-19
• K180612 — Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts2018-06-07

Injury

1,003

Other

1

Total

1,004

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →