510(k) K261462
- Device
- LANDMARK Total Knee System
- Applicant
- Smith & Nephew, Inc.
- 510(k) number
- K261462
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-08
- Date received
- 2026-05-04
- 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
- N
Applicant Contact#
- Contact
- Jessica Roach
- Address
- 1450 Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers#
- 9610612
- 2648920
- 3008868758
- 1822565
- 3002579136
- 1057425
- 8043792
- 3010287737
- 3014302784
- 3014833750
- 3021008900
- 3016090213
- 1835572
- 3006356043
- 3004450489
- 1226544
- 3010856250
- 3007366790
- 3008262872
- 3002806603
- 3006801265
- 3010047402
- 3005180920
- 2244478
- 1644408
- 3012491394
- 2134285
- 3012392319
- 3009887475
- 3030412764
- 3003477135
- 3015806723
- 3010065126
- 9613350
- 3004976965
- 3020155054
- 3008395353
- 3033509898
- 3006017180
- 3009760038
- 3002807310
- 3010057495
- 3003998208
- 3005596372
- 3004153240
- 3009813841
- 2246552
- 3009106092
- 3010388970
- 3017397663
- 3006694268
- 1833986
- 3011295718
- 3010009693
- 3010375065
- 3009732568
- 3008658204
- 2531477
- 3009555447
- 3002806470
- 3036756245
- 3010155661
- 3011015572
- 3013791180
- 3011724582
- 3005360851
- 1018470
- 3006791286
- 3003541440
- 8010379
- 3006395932
- 3010039400
- 3015207155
- 1219655
- 1828288
- 1038671
- 3009888740
- 3005751028
- 3004371426
- 3020703621
Source Documents#
Other 510(k) Records For Product Code MBH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261275 | Unity Total Knee System, Unity Knee Cementless CR Femur | Corin, Ltd. | 2026-09-17 |
| 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 |