Home › Device types › KRO
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
FDA product code KRO · Class 2 · Orthopedic
6,435
Registered devices
9,364
Adverse events
123
Recalls
87
510(k) clearances
Devices with this code
PINNACLE GRIPTION — DEPUY (IRELAND)S-ROM NOILES — DEPUY (IRELAND)LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KGEVOLUTION — Microport Orthopedics Inc.ORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, LLCOrthopedic Salvage System (OSS) — Biomet Orthopedics, LLCLinkSymphoKnee — WALDEMAR LINK GmbH & Co. KGNexGen® — Zimmer, Inc.Endo-Model Modular Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KGLinkSymphoKnee — WALDEMAR LINK GmbH & Co. KGLINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KGOSS BOWED STEM TRIAL — Biomet Orthopedics, LLCGMK-Revision/Hinge Total Knee System — Medacta International SAENDURO — Aesculap AGLinkSymphoKnee — WALDEMAR LINK GmbH & Co. KGEndo-Model Modular Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG"UNITED" USTAR II Knee System — UNITED ORTHOPEDIC CORP.LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KGOSS LOW PROFILE FEMORAL TRIAL — Biomet Orthopedics, LLCLinkSymphoKnee — WALDEMAR LINK GmbH & Co. KGLINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KGLINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KGLinkSymphoKnee — WALDEMAR LINK GmbH & Co. KGGMK Hinge Total Knee System — Medacta International SA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-06 | Waldemar Link GmbH & Co. KG (Mfg Site) | The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a pro |
| 2026-05-20 | United Orthopedic Corp. | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| 2026-05-19 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-05-19 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
| 2026-04-03 | DEPUY (IRELAND) | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.