510(k) K200782
- Device
- Triathlon Posterior Stabilized Femoral Component - Beaded With Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - Beaded With Peri-Apatite
- Applicant
- Howmedica Osteonics Corp.
- 510(k) number
- K200782
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-05-13
- Date received
- 2020-03-26
- 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
- Nora O'Connor
- Address
- 325 Corporate Dr. Mahwah NJ US 07430 07430
FDA Registration Numbers#
- 3007189546
- 9616671
- 2249615
- 3012392319
- 1835251
- 3013176080
- 3000264985
- 3017410889
- 3007311878
- 3020155054
- 1834331
- 3010220595
- 3026771806
- 3002806470
- 3002993234
- 3005751028
- 3009475821
- 3007539489
- 3010057495
- 3017397663
- 3005061536
- 3010386387
- 3015516266
- 3010123256
- 3004748528
- 9680215
- 3016851379
- 9616680
- 3009555447
- 1833920
- 1643817
- 3008110533
- 1038671
- 1226188
- 3003639920
- 1319660
- 1450662
- 3009760038
- 3015916578
- 3008544874
- 1833986
- 3004153896
- 2133928
- 3016438694
- 1722511
- 3002808022
- 3005852519
- 1825034
- 3008395353
- 3003387384
- 3010856250
- 3042172882
- 3009887475
- 9610726
- 3004450489
- 3009582259
- 1000517406
- 9681465
- 1828464
- 3012319330
- 3010287737
- 3011277306
- 3019006180
- 3009555440
- 3015207155
- 9610612
- 3008812251
- 1424263
- 3035366890
- 2183946
- 3005279746
- 3010047402
- 1219602
- 3005562917
- 3014162916
- 3007516837
- 3014302784
- 1643264
- 2032093
- 3008021110
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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