# K971070: Scarf Thread-Head (TM) Head 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.
61 later devices descend from it; 3 cite it directly.
0 of 62 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) 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) Ostcomed M3 Screw: named in the summary without a submission number

## Most influential descendants
- K050346: Stabilization Screw (2005), 55 descendants of its own
- K071639: Qwix Positioning Screw (2007), 52 descendants of its own
- K091798: Merete Compression Screws (2009), 26 descendants of its own
- K131722: I.T.S. Extremity Fixation Systems (2013), 24 descendants of its own
- K131920: Stabilization Screw (2014), 18 descendants of its own

## Indications for use
Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the hand.

Source page: https://510kreport.com/device/K971070
Methodology: https://510kreport.com/methodology