# K981261: Howmedica SCN Nail

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jun 22, 1998 after 76 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) Zimmer’s Supracondylar Intramedullary Nail: named in the summary without a submission number
- (no number) Smith & Nephew Richards’ Intramedullary Supracondylar Nail: named in the summary without a submission number

## Indications for use
The Howmedica® SCN Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the distal femur including the supracondylar region. Other types of procedures include reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions. The condyle screw when used with the condyle nut provides good fixation in osteoporotic bone and provides compression and stabilization of the supracondylar fragments.

Source page: https://510kreport.com/device/K981261
Methodology: https://510kreport.com/methodology