Apparatus, Traction, Non-Powered
FDA product code HST · Class I (low risk) · 21 CFR 888.5850 · Orthopedic
38510(k) clearances
0PMA approvals
10recalls
GMP exemptexempt from GMP rules
Manufacturers
- Orthopedic Systems, Inc. 8
- Lossing Orthopedic, Inc. 3
- Biomet, Inc. 2
- Comfortex, Inc. 2
- Smith & Nephew, Inc. 1
- Orthopedic Equipment Co., Inc. 1
- Stl International, Inc. 1
- Acufex Microsurgical, Inc. 1
- Portable Travtion Device Co. 1
- Warm & Form, Orthopedic Materials 1
- Danek Medical, Inc. 1
- American Health Tech., Inc. 1
- George W. Cottrell 1
- Ballert Orthopedic Corp. 1
- Zee Medical Products Co., Inc. 1
- The Telos Co. 1
- Tech Engineering, Inc. 1
- Robert I. Branick, M.D. 1
- Taylor Medical Equipment 1
- Haggin Industries, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162702 | Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation…HST · Traditional | Stl International, Inc. | 12/30/2016SE |
| K110858 | Lo-Bak TraxHST · Traditional | Roland F Berthiaume, DC | 08/02/2011SE |
| K984190 | Back-On-Trac, Model 101BOTHST · Traditional | Back-On-Track, Inc. | 03/15/1999SE |
| K872121 | K and D Home TractHST · Traditional | Joseph A. Kott, M.D. | 08/12/1987SE |
| K870212 | Arthroscopic Shoulder HolderHST · Traditional | Dyonics, Inc. | 02/20/1987SE |
| K870125 | Extremity ElevatorHST · Traditional | Orthopedic Systems, Inc. | 02/04/1987SE |
| K870102 | Tupper TrolleyHST · Traditional | Orthopedic Systems, Inc. | 02/03/1987SE |
| K864765 | Model 668, Traction Splint, AdultHST · Traditional | Ferno-Washington, Inc. | 12/17/1986SE |
| K862874 | The Towered 90/90 UnitHST · Traditional | Lossing Orthopedic, Inc. | 08/07/1986SE |
| K860037 | Suspender Orthopedic Suspension DeviceHST · Traditional | Comfortex, Inc. | 01/21/1986SE |
| K855179 | Transfer-Trax (TM) Splint TractionHST · Traditional | Comfortex, Inc. | 01/21/1986SE |
| K844239 | Nec-Kradle by VencorHST · Traditional | Vencor | 11/19/1984SE |
| K841388 | Acufex Shoulder HolderHST · Traditional | Acufex Microsurgical, Inc. | 05/16/1984SE |
| K841368 | Hyperbaric Oxygen Gurney-HST · Traditional | Orthopedic Systems, Inc. | 05/16/1984SE |
| K831888 | Computerized Tomography-Hyperbaric OxygHST · Traditional | Portable Travtion Device Co. | 07/12/1983SE |
| K830244 | Traction AccessoriesHST · Traditional | Warm & Form, Orthopedic Materials | 03/09/1983SE |
| K823813 | Traction AccessoriesHST · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K823395 | Traction-Steel Framing SystemHST · Traditional | Orthopedic Systems, Inc. | 12/03/1982SE |
| K823372 | Octagonal Aluminum Framing SystemHST · Traditional | Orthopedic Systems, Inc. | 12/03/1982SE |
| K823392 | Forearm Reduction UnitHST · Traditional | Orthopedic Systems, Inc. | 11/29/1982SE |
| K822993 | SenatekHST · Traditional | American Health Tech., Inc. | 10/26/1982SE |
| K821522 | Cervitrac Traction Frame & CordHST · Traditional | George W. Cottrell | 06/21/1982SE |
| K820612 | Tensoplast Skin Traction KitHST · Traditional | Smith & Nephew, Inc. | 03/31/1982SE |
| K813017 | NecktracHST · Traditional | Lossing Orthopedic, Inc. | 11/25/1981SE |
| K813016 | Zee Traction SplintHST · Traditional | Zee Medical Products Co., Inc. | 11/24/1981SE |
| K812779 | Extensions-LusatztischHST · Traditional | The Telos Co. | 10/26/1981SE |
| K803021 | Upper Extremity Traction DeviceHST · Traditional | Orthopedic Systems, Inc. | 12/12/1980SE |
| K802555 | Cottrell 90/90 BacktracHST · Traditional | Lossing Orthopedic, Inc. | 10/31/1980SE |
| K802072 | Prot-A-TracHST · Traditional | Robert I. Branick, M.D. | 09/26/1980SE |
| K792248 | Taylor Traction CordHST · Traditional | Taylor Medical Equipment | 11/30/1979SE |
| K791919 | Bac JacHST · Traditional | Haggin Industries, Inc. | 10/04/1979SE |
| K791396 | Medi-Trak Portable Traction DeviceHST · Traditional | Medicorp, Inc. | 08/16/1979SE |
| K790729 | Octagonal Aluminum Framing SystemHST · Traditional | Orthopedic Systems, Inc. | 05/01/1979SE |
| K771988 | VertetracHST · Traditional | Ballert Orthopedic Corp. | 02/01/1979SE |
| K781647 | Back TracHST · Traditional | Tech Engineering, Inc. | 10/17/1978SE |
| K780233 | Traction Weight BagsHST · Traditional | Biomet, Inc. | 02/23/1978SE |
| K780228 | Traction UnitsHST · Traditional | Biomet, Inc. | 02/23/1978SE |
| K770080 | Baker Mobile TractionHST · Traditional | Orthopedic Equipment Co., Inc. | 01/25/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1329-2024 Class II | HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support…Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System… | Baxter Healthcare Corporation | 03/11/2024Open, Classified |
| Z-1198-2017 Class II | Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex…During use, there is a potential scenario which could allow the fastening screws attaching covers to come… | Allen Medical Systems, Inc. | 01/03/2017Terminated |
| Z-0928-2017 Class II | Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed…During use, the unit could separate un-expectantly. This failure would allow the patient's arm to fall out… | Allen Medical Systems, Inc. | 11/23/2016Terminated |
| Z-1003-2015 Class II | Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by…Reports of customers falling from the Inversion Table and sustaining injuries. The Inversion Table is a… | Dick's Sporting Goods | 12/29/2014Terminated |
| Z-1063-2014 Class II | Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be…Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it… | Implantech Associates Inc | 01/29/2014Terminated |
| Z-1786-2013 Class II | STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is…A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release… | Steris Corporation | 05/20/2013Terminated |
| Z-0959-2013 Class II | Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table…Some units may have been assembled incorrectly which could result in the boot breaking free from the… | Allen Medical Systems, Inc. | 02/28/2013Terminated |
| Z-1546-2013 Class II | Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is…The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach… | Zimmer, Inc. | 02/14/2013Terminated |
| Z-0067-2010 | Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo FL 33773, Made in USA. RX only.…ConMed has determined there is a possibility that the device may not fully retract once it is deployed. | Linvatec Corp. dba ConMed Linvatec | 07/31/2009Terminated |
| Z-1603-2010 | Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by…Latex-- Certain lots of Product contain undeclared latex. | Stryker Endoscopy | 07/27/2009Terminated |