# K020962: G4 Sleeved Nail

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: May 24, 2002 after 60 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
Longest line of descent: 1 generation back to K982953 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982953: Titanium Intramedullary Nails-Various Styles, Biomet, Inc. (1998) Summary page 1.
- (no number) Kuntscher Nails: named in the summary without a submission number

## Indications for use
These devices are to be implanted into the long bones for alignment, stabilization, and fixation of fractures caused by trauma or disease, the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. Intramedullary rods are used in the femur.

Source page: https://510kreport.com/device/K020962
Methodology: https://510kreport.com/methodology