510(k) K072575
- Device
- TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE
- Applicant
- STRYKER ORTHOPAEDICS
- 510(k) number
- K072575
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-01-07
- Date received
- 2007-09-13
- 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
- TIFFANI ROGERS
- Address
- 325 Corporate Dr. Mahwah NJ US 07430 07430
FDA Registration Numbers#
- 3014162916
- 2032093
- 3010375065
- 2245304
- 9616671
- 3004748528
- 3006015326
- 3009173317
- 3009923578
- 3005852519
- 1219602
- 3016438694
- 3030412764
- 3003541440
- 2648920
- 3005562917
- 3005144609
- 3011295718
- 3003477135
- 1020279
- 3008868758
- 1000200989
- 3009888740
- 3005751028
- 3011015572
- 1226544
- 1054811
- 3009106092
- 1531174
- 3000264985
- 1064858
- 3010123256
- 3010220595
- 3010039400
- 3017397663
- 1000517406
- 1530390
- 3009973336
- 3036773273
- 1722511
- 3014302784
- 3014833750
- 1822565
- 3000236920
- 3006791286
- 3020155054
- 2183744
- 3010057495
- 2249615
- 1529009
- 3004450489
- 8043792
- 3009848551
- 3004142400
- 3016851379
- 3015916578
- 3012725451
- 9681642
- 3012329926
- 1450662
- 3011724582
- 1221763
- 1827096
- 9613369
- 3006801265
- 1833986
- 3004153240
- 3021008900
- 3013176080
- 3002807310
- 3022142628
- 3002907620
- 2531477
- 3004153896
- 1057425
- 3011187779
- 1424263
- 1018470
- 3009760038
Source Documents#
Other 510(k) Records For Product Code MBH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | Zimmer, Inc. | 2024-11-22 |
Legacy Summary#
summary
FDA Review#
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