Waldemar Link GmbH & Co. KG: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Waldemar Link GmbH & Co. KG” (first 1978, latest 2026), across 15 product codes in 2 review panels. Median 510(k) review time under this name: 102 days. Since 2017 the median was 147 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 90 |
| 2015 | 2 | 110 |
| 2016 | 1 | 257 |
| 2017 | 1 | 254 |
| 2018 | 1 | 263 |
| 2019 | 6 | 125 |
| 2020 | 2 | 58 |
| 2021 | 7 | 87 |
| 2022 | 5 | 140 |
| 2023 | 3 | 182 |
| 2024 | 1 | 155 |
| 2025 | 2 | 208 |
| 2026 | 1 | 102 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Waldemar Link GmbH & Co. KG took a median 147 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 11 | 11 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 5 | 5 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 5 | 5 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 3 | 3 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 3 | 3 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 2 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 2 | 2 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | 2 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 2 | 2 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 | 2 |
Plus 5 more product codes.
Review panels
Most recent Waldemar Link GmbH & Co. KG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various) | LZO | 2026-07-06 | 102 |
| K250375 | Allure Hip Stem and Intramedullary Plugs | MEH | 2025-11-05 | 268 |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | LZO | 2025-05-16 | 147 |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | LPH | 2024-11-08 | 155 |
| K231445 | LINK Embrace Shoulder System - Reverse Configuration | PHX | 2023-11-16 | 182 |
| K222066 | LINK MobileLink Acetabular Cup System | LPH | 2023-04-14 | 275 |
| K230471 | LinkSymphoKnee Fixed Bearing Ultracongruent (FB UC) Articulating Surface | JWH | 2023-03-21 | 28 |
| K213770 | SP-CL Hip Stem and LCU Hip System | LZO | 2022-09-13 | 285 |
| K221794 | Vario-Cup System | KWY | 2022-07-20 | 29 |
| K211567 | BiMobile Instruments (for BiMobile Dual Mobility System) | LZO | 2022-06-03 | 378 |
33 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Waldemar Link GmbH & Co. KG.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Waldemar Link GmbH & Co. KG is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT04688593: Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up (Recruiting, started 2021-05-04)
- NCT04858347: Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis (Recruiting, started 2019-07-04)
Frequently asked questions
How many FDA 510(k) clearances are listed under Waldemar Link GmbH & Co. KG?
FDA lists 43 510(k) clearances under the applicant name “Waldemar Link GmbH & Co. KG” (first 1978, latest 2026), across 15 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Waldemar Link GmbH & Co. KG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Waldemar Link GmbH & Co. KG is 102 days. Since 2017: 147 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Waldemar Link GmbH & Co. KG?
The most frequent FDA product codes under this applicant name are LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 11); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 5); KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, 5).
Next steps
- See all 43 Waldemar Link GmbH & Co. KG clearances with predicates and recalls
- Run predicate analysis for product code LZO, Waldemar Link GmbH & Co. KG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.