# K972217: Orthopedic Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Ferguson Medical
- Decided: Nov 20, 1997 after 161 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: 2 generations back to K792022 (1979). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792022: Herbert Bone Screw, Zimmer, Inc. (1979) Summary page 1.
- K792291: Synthes Reconstructive Plates 'Y' Plates, Synthes (Usa) (1979) Summary page 1.
- K921622: Alphatec Compression Hip Screw System, Alphatec Mfg., Inc. (1992) Summary page 1.
- K924018: M3 Lag Screw Fixation System, Osteomed Corp. (1993) Summary page 1.
- K931524: Fully Threaded Alta Cancellous Bone Screw, Howmedica Corp. (1994) Summary page 1.
- K940207: Titanium Alloy Bone Screws, Aesculap, Inc. (1994) Summary page 1.
- K960537: K2 Bone Screw System, Kinetikos Medical, Inc. (1996) Summary page 1.
- K961234: Depuy Advantage Fixation Screw System, Depuy, Inc. (1996) Summary page 1.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.

## Indications for use
The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.

Source page: https://510kreport.com/device/K972217
Methodology: https://510kreport.com/methodology