510(k) K202924 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
LinkSymphoKnee System
| Applicant | Waldemar Link GmbH & Co. KG, Norderstedt, DE |
| Decision | Substantially Equivalent, May 13, 2021 |
| Received | Sep 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202924
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2025 | Waldemar Link GmbH & Co. KG (Mfg Site) LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50 Open, Classified |
JWH | None listed |
| Apr 30, 2025 | Waldemar Link GmbH & Co. KG (Mfg Site) Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 88 Open, Classified |
JWH | None listed |
| Apr 30, 2025 | Waldemar Link GmbH & Co. KG (Mfg Site) Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) Open, Classified |
JWH | None listed |
| Apr 30, 2025 | Waldemar Link GmbH & Co. KG (Mfg Site) L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) Open, Classified |
JWH | None listed |
| Apr 30, 2025 | Waldemar Link GmbH & Co. KG (Mfg Site) Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880- Open, Classified |
JWH | None listed |
| Mar 17, 2025 | Waldemar Link GmbH & Co. KG (Mfg Site) Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11 Open, Classified |
JWH | None listed |
| Mar 17, 2025 | Waldemar Link GmbH & Co. KG (Mfg Site) Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12 Open, Classified |
JWH | None listed |
| Mar 17, 2025 | Waldemar Link GmbH & Co. KG (Mfg Site) Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13 Open, Classified |
JWH | None listed |
| Jul 3, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients.
Product Code: 880-3 Open, Classified |
JWH | None listed |
| Jul 3, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients.
Product Code: 880-3 Open, Classified |
JWH | None listed |
| Jun 1, 2023 | Linkbio Corp. LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6
Tilastan, cemented.
Intended for primary and revision total knee replacement.
Item Number: 880-325/13 Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.