KRO
- Product code
- KRO
- Device name
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3510
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 87 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261898 | 2026-08-06 | Howmedica Osteonics Corp. dba Stryker … | Triathlon® Knee System; Triathlon® Hinge Knee System… | |
| K252898 | 2025-12-15 | Howmedica Osteonics Corp., Dba Stryker… | Triathlon® Tritanium® Asymmetric Patella; Triathlon®… | |
| K252303 | 2025-08-22 | United Orthopedic Corporation | Stem Extension Line (USTAR II System) | |
| K251665 | 2025-07-25 | Howmedica Osteonics Corp., Dba Stryker… | Triathlon® Hinge Knee System | |
| K242871 | 2024-11-21 | Depuy Ireland UC | ATTUNE Revision Hinge Knee | |
| K240043 | 2024-04-01 | Microport Orthopedics, Inc. | EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage … | FDA |
| K233980 | 2024-03-21 | Depuy Ireland UC | ATTUNE Total Knee System, ATTUNE Cementless Knee Sys… | |
| K230563 | 2023-09-27 | Microport Orthopedics, Inc. | EVOLUTION® Hinge Knee System |
Official FDA classification page: KRO
Classification and pathway per current FDA publications. Data from openFDA (CC0).