# K972722: Ultimate Compression Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Designs, Inc.
- Decided: Jan 23, 1998 after 186 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K792022 (1979). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944330: Acutrak Plus Fixation System, Acu Med, Inc. (1995) Summary page 4.
- K792022: Herbert Bone Screw, Zimmer, Inc. (1979) Summary page 4.
- K923477: 3.5MM Universal Compression Screw, Howmedica Corp. (1993) Summary page 4.

## Indications for use
The ODi Ultimate Compression Screw System™ was designed for use on indications comparable to those for approved and marketed devices. The primary indications are for the stabilization of osteotomies in small bones, and the fixation of unstable or interfragmentary fractures. This device is not intended for use in the spine. The ODi Ultimate Compression Screw™ is indicated for: Small Hand Bone Fractures Carpal and Metacarpal Fractures Tarsal and Metatarsal Fractures Distal Metatarsal Osteotomies (Austin Chevron, Scarf) Interfragmentary Radius and Ulna Fractures Osteochondral Fractures Intra-articular fractures Arthrodesis of small joints Reconstructive osteotomies in small carpal or tarsal bones Osteochondritis Dissecans Oblique fractures of the fibula Metatarsal osteotomies and other reconstructive surgeries in the foot

Source page: https://510kreport.com/device/K972722
Methodology: https://510kreport.com/methodology