# K962236: Scarf Thread-Head Screw

- Pathway: 510(k) (Traditional)
- Applicant: Landos, Inc.
- Decided: Sep 20, 1996 after 101 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: 1 generation back to K792022 (1979). 4 ancestors in all.
548 later devices descend from it; 3 cite it directly.
1 of 553 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931155: Staple, Fixation Bone; Screw Fixation Bone, Roseburg SA (1994) Summary page 2.
- K792022: Herbert Bone Screw, Zimmer, Inc. (1979) Summary page 2.
- K924018: M3 Lag Screw Fixation System, Osteomed Corp. (1993) Summary page 2.
- K924138: Osteomed M3 System (SBF System), Osteomed Corp. (1993) Summary page 2.

## Most influential descendants
- K062352: FRS Screw (2006), 527 descendants of its own
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories (2009), 487 descendants of its own
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System (2010), 228 descendants of its own
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own
- K112583: Synthes Cortical Screws (2011), 118 descendants of its own

## Indications for use
The SCARF THREAD-HEAD™ SCREW is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.

Source page: https://510kreport.com/device/K962236
Methodology: https://510kreport.com/methodology