PIP Fix
The PIP Fix is an external skeletal fixator for unstable dorsal fracture-dislocations of the proximal interphalangeal finger joint. It maintains joint alignment while allowing active…
The PIP Fix is an external skeletal fixator for unstable dorsal fracture-dislocations of the proximal interphalangeal finger joint. It maintains joint alignment while allowing active bending and straightening during healing of the bone and surrounding soft tissues.
A surgeon places a transverse bone pin through the joint’s rotation axis and a dorsal pin into the middle phalanx. The fixator mounts on the dorsal pin and connects to the transverse pin with elastic bands, which apply the forces that maintain reduction.
Listed Item
External fixation system for dorsal fracture dislocations of the PIP joint.
Force Adjustment
Rotating the elastic-band posts changes the direction of the applied force. An angle-lock screw holds that setting, and a tension screw adjusts band tension. The sterile device and its components are intended for single use.
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Hand Biomechanics LAB, Inc., United States |
|---|---|
| FDA product code | JEC |
| Device type | Component, Traction, Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer |
| 510(k) | K181192 |
| Record published | 2019-02-20 |
| Record revised | 2025-07-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PFX-426 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 115 |
| Fragment Fixation System | Orthofix SRL | 77 |
| Anjon Bremer Halo System | Anjon Holdings, LLC | 68 |
| Sheffield Ring Fixator | Orthofix SRL | 68 |
| Hoffmann | Stryker GmbH | 65 |
| Hybrid Fixator System | Orthofix SRL | 30 |
| Triax | Stryker GmbH | 26 |
| Bremer | Depuy Spine, Inc. | 11 |
| Additional Accessories FOR THE Orthofix System | Orthofix SRL | 10 |
| Component, Traction, Invasive | Synthes Gmbh | 9 |
| Distraction, Internal | KLS-Martin L.P. | 9 |
| Halo Systems | Ossur Americas | 4 |
Showing 12 of 65. All products under Component, Traction, Invasive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181192 | 2018-10-22 |
| K072432 | 2008-01-09 |
| K030519 | 2003-06-10 |
| K984442 | 1999-02-12 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-09-14 | Class II | Under Investigation by firm | A number of Agee WristJack Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty fine-tuning the length (red) and radial/ulnar alignment (bl | 65 units | 2016-11-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.