# K963546: SMF Titanium (TI) Alloy Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jun 24, 1997 after 292 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
460 later devices descend from it; 3 cite it directly.
0 of 461 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 1.0 mm bone screws: named in the summary without a submission number
- (no number) Synthes 1.3 mm bone screws: named in the summary without a submission number
- (no number) Synthes 2.0 mm bone screws: named in the summary without a submission number
- (no number) Synthes 2.4 mm bone screws: named in the summary without a submission number

## Most influential descendants
- K974555: Synthes 2.0 MM Locking Plate System (2.0 LPS) (1998), 457 descendants of its own
- K030448: Osteomed 2.0 Locking Plates and Screws (2003), 444 descendants of its own
- K032442: KLS-Martin Mandibular/Reconstruction System II (2003), 435 descendants of its own
- K040598: KLS Martin Hand Plating System (2004), 360 descendants of its own
- K050868: Maxlock (2005), 343 descendants of its own

## Indications for use
The SMF Ti Alloy Bone Screws are intended for craniofacial and mandibular trauma and reconstruction.

Source page: https://510kreport.com/device/K963546
Methodology: https://510kreport.com/methodology