510(k) K201364
- Device
- LINK TrabecuLink Femoral Cones
- Applicant
- Waldemar Link GmbH & Co. KG
- 510(k) number
- K201364
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-07-17
- Date received
- 2020-05-22
- Regulation
- 888.3565
- Classification name
- Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Stefanie Fuchs
- Address
- Ostsraße 4-10 Norderstedt DE 22844 22844
FDA Registration Numbers#
- 1000517406
- 3009656988
- 3010065126
- 3011724582
- 1000200989
- 9680215
- 3002808022
- 3013417938
- 3009173317
- 3010041693
- 3011061242
- 3002579136
- 3016470314
- 3015916578
- 3012319330
- 1057425
- 3008281151
- 3015542154
- 3013176080
- 9681642
- 3036756245
- 1835572
- 3017397663
- 3004142400
- 9616680
- 1827096
- 1226544
- 9613369
- 3007516837
- 1220246
- 3002993234
- 1835251
- 2245304
- 1834331
- 1061927
- 3010388970
- 3005279746
- 1220477
- 3008544874
- 3011461101
- 3006395932
- 3026771806
- 2528981
- 3012491394
- 2648920
- 3009848551
- 9616671
- 9617840
- 3012392319
- 3007963827
- 2183946
- 3010536692
- 3012130008
- 1319660
- 3010386387
- 1054811
- 1020279
- 3015231789
- 3010039400
- 1835444
- 3007913880
- 3006017180
- 3005718816
- 3008262872
- 3009887475
- 3010057495
- 2134285
- 3009888740
- 3004748528
- 3011683674
- 3010287737
- 3048147961
- 3009882462
- 2032093
- 2244478
- 3009973336
- 3009106092
- 1645151
- 3004371426
- 3002907620
Source Documents#
Other 510(k) Records For Product Code MBH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | 2026-08-21 |
| K251840 | Zimmer® Persona® Personalized Knee System | Zimmer, Inc. | 2026-05-28 |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. | 2026-03-09 |
| K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | 2026-02-26 |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-02-18 |
| K253239 | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2025-12-23 |
| K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | 2025-12-19 |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | 2025-10-31 |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-10-24 |
| K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | United Orthopedic Corporation | 2025-07-31 |
| K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | 2025-05-22 |
| K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. | 2025-03-27 |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-02-13 |
| K243293 | Zimmer® Persona® Personalized Knee System | Zimmer Biomet | 2024-12-20 |
| K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | 2024-12-18 |
Legacy Summary#
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FDA Review#
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