KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Class II
FDA product code KRO covers "Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer", a Class II medical device regulated under 21 CFR 888.3510. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KRO
- Device Class
- Class II
- Regulation Number
- 888.3510
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252898 | howmedica osteonics corp., dba stryker orthopaedics | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patell | December 15, 2025 |
| K252303 | united orthopedic corporation | Stem Extension Line (USTAR II System) | August 22, 2025 |
| K251665 | howmedica osteonics corp., dba stryker orthopaedics | Triathlon® Hinge Knee System | July 25, 2025 |
| K242871 | depuy ireland uc | ATTUNE Revision Hinge Knee | November 21, 2024 |
| K240043 | microport orthopedics | EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Fe | April 1, 2024 |
| K233980 | depuy ireland uc | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation S | March 21, 2024 |
| K230563 | microport orthopedics | EVOLUTION® Hinge Knee System | September 27, 2023 |
| K230416 | stryker | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | May 19, 2023 |
| K223069 | howmedica osteonics corp., dba stryker orthopaedics | Modular Rotating Hinge Knee Systems and Compatible Components | April 21, 2023 |
| K223528 | howmedica osteonics corp., dba stryker orthopaedics | Triathlon® Hinge Knee System | January 20, 2023 |
| K220628 | waldemar link gmbh and co. kg | LINK Endo-Model EVO Knee System | May 3, 2022 |
| K211677 | onkos surgical | ELEOS Limb Salvage System | July 28, 2021 |
| K211768 | waldemar link gmbh and co. kg | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | June 30, 2021 |
| K210010 | medacta international | GMK Revision & Hinge Extension - TiNbN Coating | March 2, 2021 |
| K192798 | zimmer | Zimmer Segmental System | December 10, 2020 |
| K190181 | linkbio | Instruments for LINK MEGASYSTEM-C Family | October 25, 2019 |
| K191779 | depuy(ireland) | Attune Revision LPS Inserts | October 8, 2019 |
| K190100 | united orthopedic corporation | USTAR II System | September 23, 2019 |
| K172347 | medacta international | GMK Hinge, GMK Revision | November 1, 2017 |
| K163311 | medacta international | GMK Revision Femoral Distal Augmentation | December 21, 2016 |