510(k) K180612
- Device
- Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
- Applicant
- Howmedica Osteonics Corp Aka Stryker Orthopaedics
- 510(k) number
- K180612
- Product code
- HSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-06-07
- Date received
- 2018-03-08
- Regulation
- 888.3520
- Classification name
- Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, 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
- Emily DiMambro
- Address
- 325 Corporate Dr. Mahwah NJ US 07430 07430
FDA Registration Numbers#
- 3007539489
- 2242737
- 3010331645
- 3015806723
- 2031093
- 3006783837
- 1828464
- 1526534
- 1818910
- 2528981
- 3003541440
- 1000517406
- 1721676
- 1720929
- 3011015572
- 1424263
- 3010039400
- 9681465
- 9614209
- 3003477135
- 3007311878
- 3004371426
- 3009973336
- 9616671
- 3007963827
- 2249615
- 9616680
- 1220246
- 3016090213
- 3033509898
- 1822565
- 2532027
- 3006946276
- 3011534620
- 1825034
- 1222928
- 3020155054
- 3010178296
- 9610726
- 3016851379
- 1833920
- 3009732568
- 3004153240
- 3010049501
- 1054811
- 3035366890
- 2183744
- 1000550978
- 2028632
- 1220477
- 1057425
- 3000264985
- 2245304
- 3027737826
- 3015231789
- 3015542154
- 3013194153
- 1827096
- 3021008900
- 1423662
- 1000200989
- 3010047402
- 3038503932
- 3001239363
- 3010163695
- 1644408
- 9613369
- 1450662
- 3006801265
- 3011295718
- 1828288
- 3022142628
- 3006395932
- 3002907620
- 3007993775
- 3011274144
- 3009882462
- 3007366790
- 3006017180
- 3004358587
Source Documents#
Other 510(k) Records For Product Code HSX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2026-04-02 |
| K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. | 2025-12-16 |
| K251834 | Persona Partial Knee | Zimmer Biomet | 2025-08-15 |
| K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | 2025-07-24 |
| K251453 | Arthrex iBalance Partial Knee System | Arthrex, Inc. | 2025-07-01 |
| K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | 2024-12-06 |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. | 2024-10-30 |
| K242746 | OvertureTi Knee Resurfacing SystemTM | Overture Orthopaedics | 2024-10-07 |
| K232114 | TRIBRID® Unicompartmental Knee System | Kyocera Medical Technologies, Inc. | 2024-04-04 |
| K221292 | Uni Knee Resurfacing System | Overture Resurfacing, Inc. | 2023-03-10 |
| K212870 | TLC Unicompartmental Knee System | Signature Orthopaedics Pty, Ltd. | 2022-06-16 |
| K220930 | Restoris Multi-Compartmental Knee System | Mako Surgical Corp. | 2022-06-02 |
| K211471 | Balanced Knee System Uni | Ortho Development Corporation | 2021-12-16 |
| K213071 | MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International S.A. | 2021-11-16 |
| K212307 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021-10-12 |
Legacy Summary#
summary
FDA Review#
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