510(k) K903286
- Device
- CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION
- Applicant
- TECHMEDICA, INC.
- 510(k) number
- K903286
- Product code
- HSX
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1990-10-12
- Date received
- 1990-07-16
- 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
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVE MARTINEZ
- Address
- 3760 Calle Tecate Camarillo CA US 93012 93012
FDA Registration Numbers#
- 2249697
- 3036756245
- 3003541440
- 1000517406
- 3027737826
- 3010400367
- 3004142400
- 1722511
- 3009241418
- 3012319330
- 1827096
- 1720929
- 1223434
- 3011534620
- 3014763043
- 3002807295
- 3004358587
- 9681465
- 9616680
- 1000200989
- 3010536692
- 3007539489
- 1000550978
- 3010375065
- 3013302242
- 3011187779
- 2532027
- 3006783837
- 3003477135
- 3010173425
- 9613369
- 3010041693
- 3021008900
- 3022142628
- 1057425
- 3016851379
- 3006395932
- 2031093
- 3016090213
- 3015207155
- 3013194153
- 3002579136
- 3005144609
- 3009888740
- 1828464
- 2242737
- 2183744
- 3015542154
- 3013055499
- 3005180920
- 3004371426
- 3005718816
- 3009555447
- 3005061536
- 3005551626
- 1818910
- 3033509898
- 3030412764
- 2245304
- 3010220595
- 3010049501
- 1018470
- 3004154314
- 3020703621
- 3007993775
- 1645151
- 3001239363
- 3015398319
- 3004976965
- 3011015572
- 2133928
- 3012523063
- 3020155054
- 3009848551
- 1526534
- 3009888344
- 1828288
- 2030624
- 3025603301
- 3011061242
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases