Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System— 510(k) K261898
Substantially EquivalentHowmedica Osteonics Corp. dba Stryker Orthopaedics
FDA 510(k) clearance K261898 for Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System, Substantially Equivalent on 2026-08-06. Applicant: Howmedica Osteonics Corp. dba Stryker Orthopaedics. Device class: 2.
Summary
Howmedica Osteonics, doing business as Stryker Orthopaedics, filed the Triathlon Knee System, Triathlon Hinge Knee System, and Scorpio Total Knee System together. The product code is KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer).
Class II, 21 CFR 888.3510. Orthopedic is both the classification panel and the review panel, and it was a Traditional 510(k).
The applicant filed from Mahwah, New Jersey. The decision came 62 calendar days after FDA received it (June 5 to August 6, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Howmedica Osteonics Corp. dba Stryker Orthopaedics
- Product code
- Product code KRO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3510
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Recent devices under product code KRO
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- K250989 — Stryker and Serf hip devices
- K243784 — Stryker Orthopaedics Hip Devices Labeling Update
Adverse events under product code KRO
product code KRO- Death
- 19
- Injury
- 4,841
- Total
- 4,860
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.