# K972813: Gamma Locking Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Oct 9, 1997 after 72 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices 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’s Standard Gamma Locking Nails: named in the summary without a submission number
- (no number) Howmedica’s Long Gamma Locking Nails: named in the summary without a submission number
- (no number) Howmedica's Omega Compression Hip Screw System: named in the summary without a submission number

## Most influential descendants
- K143245: GPC Intramedullary Nailing Systems (2015), 2 descendants of its own
- K033286: Odi Talon Long Proximal Femoral Nail System (2004), 2 descendants of its own
- K111352: Talon Distalfix Proximal Femoral Nail (2011), 1 descendant of its own
- K253517: Reselute Tibial Nail (2026), 0 descendants of its own
- K223933: Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (2023), 0 descendants of its own

## Indications for use
This device is intended for use in stabilizing various types of intertrochanteric fractures of the proximal femur.

Source page: https://510kreport.com/device/K972813
Methodology: https://510kreport.com/methodology