510(k) K152315
- Device
- JOURNEY II Uni Tibial Base And Insert
- Applicant
- Smith & Nephew, Inc.
- 510(k) number
- K152315
- Product code
- HSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-10-28
- Date received
- 2015-08-17
- Regulation
- 888.3520
- Classification name
- Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- 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#
- 3010097171
- 3014302784
- 3001239363
- 1424263
- 3010220595
- 3035366890
- 1825034
- 3015806723
- 3015207155
- 3010009693
- 3009848551
- 3005180920
- 3010178296
- 9614209
- 3004358587
- 1057425
- 3007963827
- 1722511
- 1054811
- 3008102042
- 3000264985
- 3038503932
- 3012319330
- 2532027
- 3002807295
- 2242737
- 1043653
- 2249697
- 1833920
- 3004153240
- 1000200989
- 3005551626
- 3013014058
- 3011187779
- 1220246
- 2028632
- 3005144609
- 3013176080
- 3010375065
- 3008868758
- 3020155054
- 3015542154
- 9681465
- 1000550978
- 3025603301
- 9613369
- 3011534620
- 2246552
- 3007993775
- 1000517406
- 1018470
- 3014763043
- 1526534
- 3027737826
- 3009887475
- 3009555447
- 3009732568
- 3002579136
- 3013194153
- 1048735
- 1721676
- 3010173425
- 3009888740
- 3010049501
- 3020703621
- 2030624
- 1818910
- 2249615
- 3011015572
- 3004976965
- 1223434
- 3010047402
- 3008110533
- 1720929
- 1061927
- 1450662
- 3010163695
- 3030412764
- 3004154314
- 3010536692
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