# K971068: 34MM Scarf Thread-Head (TM) Screw

- Pathway: 510(k) (Traditional)
- Applicant: Landos, Inc.
- Decided: Jul 9, 1997 after 107 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Landos SCARF Thread-Head Screw: named in the summary without a submission number
- (no number) Zimmer Herbert-Whipple Bone Screw: named in the summary without a submission number
- (no number) Osteomed M3 Screw: named in the summary without a submission number

## Indications for use
Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the mid-foot, metatarsals and phalanges of the foot.

Source page: https://510kreport.com/device/K971068
Methodology: https://510kreport.com/methodology