# K992350: Pylon Intramedullaary Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Mfg., Inc.
- Decided: Sep 22, 1999 after 70 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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) ACE AIM Titanium Nails (Depuy ACE, a Johnson and Johnson company): named in the summary without a submission number

## Indications for use
The Pylon Intramedullary Nail System is indicated for internal fixation of tibial or femoral fractures including low subtrochanteric fractures, transverse fractures, oblique and spiral fractures, segmental fractures, comminuted fractures, high supracondylar fractures, fractures with bone loss, stabilization for bone transport or lengthening and shortening, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the bone shaft, nonunions, malunions, metaphyseal/diaphyseal junction fractures, and acute bone lengthening and shortening.

Source page: https://510kreport.com/device/K992350
Methodology: https://510kreport.com/methodology