Orthopedic Systems, Inc.
Medical device manufacturer in Union City, CA.
95510(k) clearances
0PMA approvals
1recalls
Device types
- FWZ Operating Room Accessories Table Tray 8
- HST Apparatus, Traction, Non-Powered 8
- JDI Prosthesis, Hip, Semi-Constrained… 7
- HRX Arthroscope 6
- HWC Screw, Fixation, Bone 4
- LWJ Prosthesis, Hip, Semi-Constrained… 3
- KQX Goniometer, Ac-Powered 3
- JEB Table, Surgical With Orthopedic… 2
- IKK System, Isokinetic Testing And Evaluation 2
- GEY Motor, Surgical Instrument, Ac-Powered 2
- HXY Brace, Drill 2
- ITQ Joint, Knee, External Brace 2
- JDG Prosthesis, Hip, Femoral Component… 2
- LXH Orthopedic Manual Surgical Instrument 2
- JEA Table, Surgical With Orthopedic… 2
- IQM Splint, Temporary Training 2
- ILH Splint, Hand, And Components 1
- JWH Prosthesis, Knee, Patellofemorotibial… 1
- IPM Cover, Limb 1
- FYH Splint, Extremity, Noninflatable, External… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | 01/22/1996SE |
| K920256 | Spine Motion Analyzer with EmgKQX · Traditional | 08/10/1992SE |
| K910736 | Jackson Multipurpose Operating TableJEA · Traditional | 05/21/1991SE |
| K910031 | Park City Shoulder PositionerFWZ · Traditional | 01/24/1991SE |
| K903938 | C Fit CupJDI · Traditional | 01/04/1991SN |
| K892503 | Nuffield Total KneeJWH · Traditional | 05/04/1990SN |
| K896678 | Silicone PlugHRX · Traditional | 01/30/1990SE |
| K894283 | Comprehensive Spine Motion AnalyzerKQX · Traditional | 01/19/1990SE |
| K890498 | Freeman Modular Hip Stem Ridged VersionJDI · Traditional | 10/13/1989SN |
| K890331 | Freeman Total Hip System Ridged StemLWJ · Traditional | 10/13/1989SE |
| K895219 | Cancellous Screw Long Thread Diameter 6.5MMHWC · Traditional | 09/12/1989SE |
| K895218 | Cancellous Screw Short Thread Diameter 6.5MMHWC · Traditional | 09/12/1989SE |
| K895217 | Cortical ScrewHWC · Traditional | 09/12/1989SE |
| K894249 | Universal Cemented CupJDI · Traditional | 08/03/1989SE |
| K891539 | Cti II Straight StemLWJ · Traditional | 06/08/1989SE |
| K891903 | Cohn TargeteerLXH · Traditional | 05/15/1989SE |
| K890187 | The C-S Distraction Rod AssemblyKWP · Traditional | 04/06/1989SE |
| K890185 | C-S ImpactorLYP · Traditional | 04/06/1989SE |
| K875130 | Bone Nail W/Washer & an Arthroscopic Insertion SysHRX · Traditional | 01/30/1989SE |
| K884483 | CruciometerJZE · Traditional | 01/18/1989SE |
| K884641 | Bovac Smoke CollectorGEI · Traditional | 12/22/1988SE |
| K883457 | ASST-3000 Spinal Surgery TableFWY · Traditional | 08/26/1988SE |
| K881511 | Fixator Pin (External)JDW · Traditional | 06/30/1988SE |
| K881289 | Corin Bipolar ProsthesisKWY · Traditional | 06/29/1988SE |
| K881288 | Corin Modular Moore StemLWJ · Traditional | 06/29/1988SE |
| K880203 | Herman Cannula SetHRX · Traditional | 04/14/1988SE |
| K881060 | Osi Rizzoli Trauma Table (Electric Version)JEA · Traditional | 03/25/1988SE |
| K880264 | Bone Suture Fixation DeviceHXY · Traditional | 03/23/1988SN |
| K880263 | Osi Rizzoli Orthopedic Table/Manual VersionJEB · Traditional | 03/15/1988SE |
| K880253 | Blakemore RetainerFEF · Traditional | 03/11/1988SE |
| K880265 | Wehbe Arm HolderFWZ · Traditional | 02/18/1988SE |
| K874616 | Moore Hip Prosthesis Fenestrated StemJDI · Traditional | 01/29/1988SE |
| K874599 | Moore Hip Prosthesis Solid StemJDI · Traditional | 01/29/1988SE |
| K875235 | Isokinetic System, Testing and EvaluationIKK · Traditional | 01/19/1988SE |
| K873660 | Roper-Tuke ElbowJDB · Traditional | 01/06/1988SN |
| K873626 | Freeman Total Hip System Titanium Modular SystemJDI · Traditional | 12/31/1987SN |
| K873627 | Cti Straight StemJDG · Traditional | 12/30/1987SE |
| K874617 | Thompson Hip ProsthesisJDG · Traditional | 12/10/1987SE |
| K874130 | Titanium Bone ScrewsHWC · Traditional | 12/07/1987SE |
| K873632 | Hi-Nek Total HipJDI · Traditional | 12/07/1987SE |
| K874300 | AesthesiometerGWI · Traditional | 11/06/1987SE |
| K871323 | Arthroscopic Meniscal Suture SystemHWT · Traditional | 05/01/1987SE |
| K871287 | Orthopedic Drill GuideHSZ · Traditional | 04/15/1987SE |
| K871225 | Hand Surgery Table ExtensionFWZ · Traditional | 04/07/1987SE |
| K870105 | Infant Cast Table · Traditional | 02/06/1987SE |
| K870104 | Radiolucent Table ExtensionFWZ · Traditional | 02/06/1987SE |
| K870101 | Clark Socket, Side Rail Socket, Side Rail SectionFWZ · Traditional | 02/06/1987SE |
| K870099 | Pivoting Surgical Arm Boards · Traditional | 02/06/1987SE |
| K870098 | Lithotomy HoldersFWZ · Traditional | 02/06/1987SE |
| K870125 | Extremity ElevatorHST · Traditional | 02/04/1987SE |
| K870126 | Femur WrenchGEG · Traditional | 02/03/1987SE |
| K870102 | Tupper TrolleyHST · Traditional | 02/03/1987SE |
| K870100 | Plaster StandLGG · Traditional | 01/28/1987SE |
| K870103 | Lead Apron CaddyEAJ · Traditional | 01/21/1987SE |
| K864879 | Osi Papoose Board · Traditional | 01/21/1987SE |
| K864878 | Icu/Cpu Transport TrayFNJ · Traditional | 01/06/1987SE |
| K864881 | Arthroscopic Ankle HolderFWZ · Traditional | 12/29/1986SE |
| K864880 | Collins Positioning DeviceFWZ · Traditional | 12/29/1986SE |
| K862991 | Ligament WasherHRX · Traditional | 10/29/1986SE |
| K862990 | Cancellous ScrewHRX · Traditional | 10/29/1986SE |
| K861622 | Sagittal & Rotary Act/Pass Knee Ligament TesterIKK · Traditional | 05/27/1986SE |
| K861268 | Arthroscope W/Cannulated Obtur/Drill Bits & WrenchHRX · Traditional | 05/16/1986SE |
| K853764 | Tendon Leader · Traditional | 10/07/1985SE |
| K853763 | Tendon Stripper · Traditional | 10/07/1985SE |
| K853762 | Isometric Acl Drill GuideGEY · Traditional | 10/07/1985SE |
| K853761 | Drilling TemplateGEY · Traditional | 10/07/1985SE |
| K841368 | Hyperbaric Oxygen Gurney-HST · Traditional | 05/16/1984SE |
| K832494 | Scoliometer · Traditional | 08/16/1983SE |
| K831040 | Lamoreux-Osi ElectrogoniometerKQX · Traditional | 07/12/1983SE |
| K831044 | Limited Motion Functional Knee BraceITQ · Traditional | 06/24/1983SE |
| K831041 | Sagittal Knee TesterFTY · Traditional | 06/24/1983SE |
| K831042 | Chemonucleolysis Table ExtensionFSE · Traditional | 05/16/1983SE |
| K831043 | Andrews Remote Chuck DrillHXY · Traditional | 04/28/1983SE |
| K823395 | Traction-Steel Framing SystemHST · Traditional | 12/03/1982SE |
| K823394 | Walking HeelLGF · Traditional | 12/03/1982SE |
| K823393 | Stax Finger SplintsILH · Traditional | 12/03/1982SE |
| K823372 | Octagonal Aluminum Framing SystemHST · Traditional | 12/03/1982SE |
| K823400 | Arthroscopic Leg Holder · Traditional | 11/29/1982SE |
| K823399 | Cover LimbIPM · Traditional | 11/29/1982SE |
| K823397 | Anatomic Fracture BraceITQ · Traditional | 11/29/1982SE |
| K823396 | Free Flex Heel Height AdjustorISH · Traditional | 11/29/1982SE |
| K823392 | Forearm Reduction UnitHST · Traditional | 11/29/1982SE |
| K823391 | Leg Prep Holder · Traditional | 11/29/1982SE |
| K823398 | Lateral Positioner · Traditional | 11/24/1982SE |
| K822885 | Halo Traction Cervical ImmobilizationHAX · Traditional | 11/22/1982SE |
| K811015 | Positive Closure Anesthetic ValveCAI · Traditional | 05/15/1981SE |
| K803029 | TLC Support Products · Traditional | 12/22/1980SE |
| K803021 | Upper Extremity Traction DeviceHST · Traditional | 12/12/1980SE |
| K801436 | Orthopedic Lower Extremity SuspensionFYH · Traditional | 06/26/1980SE |
| K801214 | Hamilton Tuckaway DeskKNO · Traditional | 05/30/1980SE |
| K790729 | Octagonal Aluminum Framing SystemHST · Traditional | 05/01/1979SE |
| K771109 | Orthopedic Soft GoodsHSS · Traditional | 06/27/1977SE |
| K771020 | Spinal Surgery FrameJEB · Traditional | 06/17/1977SE |
| K770891 | Splinh, ForearmIQM · Traditional | 05/26/1977SE |
| K770890 | Splint, CockupIQM · Traditional | 05/26/1977SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0780-2007 | Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s…Material used to manufacture accessory bracket does not meet product specification. The screw is normally… | 02/14/2007Terminated |