# K202924: LinkSymphoKnee System

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: May 13, 2021 after 226 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K936079 (1994). 32 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182872: LINK GEMINI SL Total Knee System, Waldemar Link GmbH & Co. KG (2019) Summary page 4.
- K072531: Legion Stem with Holes, Smith & Nephew, Inc. (2007) Summary page 4.
- K041106: Revision Knee System, Smith & Nephew, Inc. (2004) Summary page 4.
- K043440: Smith & Nephew, Inc. Revision Knee System, Smith & Nephew, Inc. (2005) Summary page 4.
- K953274: Genesis Porous Tibial Trays & Revision Knee System, Smith & Nephew Richards, Inc. (1996) Summary page 4.
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 4.
- K143179: The LINK® Endo-Model® Knee System, Waldemar Link GmbH & Co. KG (2015) Summary page 5.
- K152431: LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating, Waldemar Link GmbH & Co. KG (2016) Summary page 5.

## Most influential descendants
- K230471: LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface (2023), 0 descendants of its own
- K220628: LINK Endo-Model EVO Knee System (2022), 0 descendants of its own

## Recalls of this device
- Jul 31, 2025 · Class II · Z-2541-2025: Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
- Apr 3, 2025 · Class II · Z-1701-2025: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Apr 3, 2025 · Class II · Z-1702-2025: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Apr 3, 2025 · Class II · Z-1699-2025: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Apr 3, 2025 · Class II · Z-1700-2025: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Feb 14, 2025 · Class II · Z-1373-2025: A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
- Feb 14, 2025 · Class II · Z-1372-2025: A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
- Feb 14, 2025 · Class II · Z-1374-2025: A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
- Apr 25, 2023 · Class II · Z-1674-2023: Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
- Dec 23, 2022 · Class II · Z-2067-2023: Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
- Dec 23, 2022 · Class II · Z-2066-2023: Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).

## Indications for use
General: The LinkSymphoKnee System is intended for primary and revision total knee replacement in skeletally mature patients with the following conditions. This device is intended for cemented use only unless a cementless modular stem is indicated for use. Indications: • Primary degenerative arthritis / osteoarthritis • Secondary arthritis resulting from rheumatoid arthritis • Fracture

Source page: https://510kreport.com/device/K202924
Methodology: https://510kreport.com/methodology