510(k) K221705
- Device
- U2 Total Knee System-PF+
- Applicant
- United Orthopedic Corporation
- 510(k) number
- K221705
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-02-28
- Date received
- 2022-06-13
- 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
- Lois Ho
- Address
- No 57, Park Ave. 2, Science Park Hsinchu City TW 30075 30075
FDA Registration Numbers#
- 3009888740
- 3000236920
- 3010057495
- 1721676
- 3011461101
- 3009555440
- 3016470314
- 3000264985
- 1226544
- 3013791180
- 9681465
- 1833986
- 1220246
- 3010041693
- 2242737
- 3009923578
- 3005562917
- 3020703621
- 1834331
- 3009475821
- 3004450489
- 3008021110
- 3013417938
- 3011061242
- 3005718816
- 3010375065
- 8010379
- 3007516837
- 1645151
- 3022142628
- 3004153240
- 3009973336
- 3015916578
- 3012329926
- 3014302784
- 3025603301
- 3003477135
- 3006015326
- 3008262872
- 3009293341
- 3009555447
- 3006395932
- 9613369
- 1526534
- 1649518
- 3014763043
- 3002808022
- 2528981
- 3006694268
- 3007189546
- 3008572101
- 3017410889
- 3013055499
- 3005852519
- 3002806603
- 3012491394
- 3002807314
- 1835572
- 3019006180
- 1047843
- 3038503932
- 2249697
- 3005279746
- 3010039400
- 3010386387
- 3011277306
- 3011015572
- 1221763
- 9613350
- 2134285
- 3016090213
- 3011724582
- 3007539489
- 1018470
- 2246552
- 1061927
- 3008812251
- 1054811
- 3015516266
- 2245304
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 |