# K980788: Alphatec Wire External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Mfg., Inc.
- Decided: May 22, 1998 after 81 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
External Fixation is useful in many areas of orthopedic surgery. Following are the major categories of application: 1) Limb salvage from traumatic injury. 2) Fracture treatment (i.e. long bone fracture, including the tibia, femur, humerous, radius, and ulnar bones). 3) Reconstruction of extremities with deformity and dysfunction. 4) Arthrodesis. The surgeon must carefully evaluate the purpose for external fixation in the individual patient if the treatment is to be successful. Consideration should be given to the following factors necessary for the successful application of an external fixator. Fracture osteotmy stability, soft tissue viability, adjacent function or injury, and functional demands of the patient.

Source page: https://510kreport.com/device/K980788
Methodology: https://510kreport.com/methodology