# K993873: Alphatec External Fixation System Compression/Distraction Rod

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Mfg., Inc.
- Decided: Jan 3, 2000 after 49 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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. The FDA summary names its predicate without a number.
- (no number) Howmedica Hoffmann II External Fixation System: named in the summary without a submission number
- (no number) Ace Unifix External Fixation System: named in the summary without a submission number
- (no number) Smith & Nephew Ilizarov External Fixator: named in the summary without a submission number

## Indications for use
The Alphatec External Fixation System is indicated for limb salvage from traumatic injury; fracture treatment (i.e., long bone fracture, including the tibia, femur, humerus, radius, and ulnar bones); reconstruction of extremities with deformity and dysfunction; limb lengthening; arthrodesis; and pelvic fractures.

Source page: https://510kreport.com/device/K993873
Methodology: https://510kreport.com/methodology