# K032634: Normed Compression Bone Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Noviace Corporation
- Decided: Oct 6, 2003 after 41 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K151708: RECON system - Compression Screws (2016), 0 descendants of its own

## Indications for use
The Normed Compression Bone Screw System intended for use for fiactures or arthrodesis of carpals and metacarpals, radial head and radial stolid fractures, metatarsal fractures and osteotomies of the forefoot and intra- artcular arthrodesis in the wrist, pseudo-arthrosis, degenerative alteration and corrective osteotomies aiming to fiinctionally stable osteosynthesis such as, but not limited to scaphoid fractures, fractures of other carpal bones, scaphoid pseudearthrosis, intercarpal arthrodesis, arthrodesis of fmger eng and metacarpal joints and fractures of ulna head and radius head.

Source page: https://510kreport.com/device/K032634
Methodology: https://510kreport.com/methodology