# K963172: Synthes Sterile 4.5 MM Cannulated Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 8, 1996 after 86 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
No predicates in its family tree.
722 later devices descend from it; 20 cite it directly.
0 of 723 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 its predicate without a number.
- (no number) Synthes 4.0 mm Cancellous Screws: named in the summary without a submission number

## Most influential descendants
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), 306 descendants of its own
- K102343: Emerge Medical Cannulated Screw Fixation System (2010), 220 descendants of its own
- K103705: Low Profile Screws (2011), 219 descendants of its own
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), 217 descendants of its own
- K082874: Biodrive Cannulated Screw System (2009), 168 descendants of its own

## Indications for use
Synthes 4.5 mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.

Source page: https://510kreport.com/device/K963172
Methodology: https://510kreport.com/methodology