510(k) K251771
- Device
- Cambridge Partial Knee
- Applicant
- Signature Orthopaedics Pty, Ltd.
- 510(k) number
- K251771
- Product code
- HSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-16
- Date received
- 2025-06-10
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Declan Brazil
- Address
- 7 Sirius Rd. Lane Cove West AU 2066 2066
FDA Registration Numbers
- 1423662
- 1450662
- 1000200989
- 2242737
- 3005180920
- 2133928
- 3009241418
- 3013176080
- 3017410889
- 3021008900
- 3006801265
- 3001239363
- 1421101
- 2183744
- 1644408
- 1834331
- 3003541440
- 1018470
- 3020703621
- 3000264985
- 3013194153
- 3007963827
- 1833920
- 1827096
- 3002579136
- 3015806723
- 3025603301
- 3005061536
- 2031093
- 3010163695
- 3004142400
- 1643264
- 1223434
- 3016090213
- 2028632
- 3004358587
- 1043653
- 1219655
- 2246552
- 3014763043
- 1721676
- 3011061242
- 2532027
- 3010041693
- 3006395932
- 3004976965
- 3013302242
- 3013014058
- 3010039400
- 2249697
- 3010331645
- 3012523063
- 3016438694
- 3009973336
- 3008110533
- 3010097171
- 3015231789
- 3002907620
- 3015398319
- 3002808022
- 3004153240
- 3038503932
- 9681465
- 3010400367
- 3011015572
- 3030412764
- 1057425
- 1645151
- 1000550978
- 3010047402
- 3007311878
- 3011534620
- 3009882462
- 3009732568
- 3020155054
- 1526534
- 3002807295
- 1828288
- 1828464
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code HSX
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|---|---|---|---|
| K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2026-04-02 |
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| 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 |
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| 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 |
| K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | 2021-09-16 |