# K982873: Zeta Multizone SCN Locking Nail

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Oct 21, 1998 after 68 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) Howmedica’s SCN Nail: named in the summary without a submission number
- (no number) Depuy Ace’s AIM® Titanium Supracondylar Nail: named in the summary without a submission number

## Indications for use
The Zeta MultiZone SCN Locking 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/K982873
Methodology: https://510kreport.com/methodology