# Waldemar Link GmbH & Co. KG

- Location (FDA's records): Norderstedt, DE
- FDA decisions: 43 (1978–2026): 43 510(k) clearances
- Product codes: LZO (11), KRO (5), JWH (5), PHX (3), LPH (3), MEH (2), MBH (2), KWY (2), JDI (2), KWA (2), KXA (2), LWJ (1)
- 510(k) review time since 2016: median 155 days, against 112 for FDA's reviews in the same codes and years (11 of 26 faster)
- Predicates its devices cite: 117 (39 its own); citations of its devices by later devices: 45 (39 its own)
- Recalls linked to its devices: 70 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biomet Manufacturing Corp: 7 (https://510kreport.com/company/biomet-manufacturing)
- Biomet, Inc.: 7 (https://510kreport.com/company/biomet)
- Corin USA: 5 (https://510kreport.com/company/corin-usa)
- DePuy Orthopaedics, Inc.: 4 (https://510kreport.com/company/depuy-orthopaedics)
- Howmedica Osteonics Corp.: 4 (https://510kreport.com/company/howmedica-osteonics)
- Zimmer, Inc.: 4 (https://510kreport.com/company/zimmer)
- Lima-Lto S.P.A.: 4 (https://510kreport.com/company/lima-lto)
- Link America, Inc.: 3 (https://510kreport.com/company/link-america)

## Firms that cite its devices most
- LinkBio Corp.: 3 (https://510kreport.com/company/linkbio)
- Medacta International S.A.: 2 (https://510kreport.com/company/medacta-international)
- Maxx Orthopedics, Inc.: 1 (https://510kreport.com/company/maxx-orthopedics)

## Its most-cited devices
- K182321: MobileLink Acetabular Cup System (2019), cited by 6
- K152431: LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating (2016), cited by 5
- K143179: The LINK® Endo-Model® Knee System (2015), cited by 5
- K151008: Link® Megasystem-C® (2015), cited by 4
- K182872: LINK GEMINI SL Total Knee System (2019), cited by 4
- K200368: LINK Embrace Shoulder System - Reverse Configuration (2021), cited by 3

## Recent decisions
- K261009: MobileLink Acetabular Cup System – 40mm ID Inserts (various) (Jul 6, 2026)
- K250375: Allure Hip Stem and Intramedullary Plugs (Nov 5, 2025)
- K243927: MobileLink Acetabular Cup System - inhouse coatings (May 16, 2025)
- K241636: MobileLink Acetabular Cup System - Line Extension (Multiple) (Nov 8, 2024)
- K231445: LINK Embrace Shoulder System - Reverse Configuration (Nov 16, 2023)
- K222066: LINK MobileLink Acetabular Cup System (Apr 14, 2023)
- K230471: LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface (Mar 21, 2023)
- K213770: SP-CL Hip Stem and LCU Hip System (Sep 13, 2022)

Source page: https://510kreport.com/company/waldemar-link