510(k) K211221
- Device
- Porous Patella And Porous Tibia Baseplate
- Applicant
- Smith & Nephew, Inc.
- 510(k) number
- K211221
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-10-01
- Date received
- 2021-04-23
- 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
- Brad Sheals
- Address
- 7135 Goodlett Farms Pkwy. Cordova TN US 38016 38016
FDA Registration Numbers#
- 1835251
- 3010856250
- 2183946
- 3016851379
- 3016470314
- 3013055499
- 3021008900
- 3005360851
- 3016438694
- 9681465
- 3014763043
- 1450662
- 1226188
- 3000264985
- 3010057495
- 3006801265
- 3003387384
- 3036773273
- 3008868758
- 9681642
- 3005751028
- 1061927
- 3010039400
- 3014162916
- 3003639920
- 2134285
- 3007963827
- 1832228
- 3006356043
- 2249615
- 3011724582
- 1833920
- 3005581234
- 3011015572
- 3013014058
- 1643817
- 3011187779
- 3008544874
- 3002993234
- 3002808022
- 8010379
- 3013176080
- 3004371426
- 2032093
- 3011061242
- 1057425
- 1054811
- 3010009693
- 1835444
- 3012392319
- 1529009
- 3012130008
- 3013417938
- 3002806470
- 8043792
- 3038503932
- 3005061536
- 1834331
- 3004153240
- 3010047402
- 9613350
- 3010388970
- 3012725451
- 3016090213
- 3026771806
- 3009973505
- 3022142628
- 1818910
- 3000236920
- 3014302784
- 1424263
- 3005279746
- 3011277306
- 1720929
- 3035366890
- 3009555440
- 3009293341
- 2183744
- 9680215
- 1643264
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 |
| K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026-09-08 |
| 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 |
Legacy Summary#
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FDA Review#
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