# K962233: Twist-Off Screw

- Pathway: 510(k) (Traditional)
- Applicant: Landos, Inc.
- Decided: Oct 3, 1996 after 114 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 K924138 (1993). 4 ancestors in all.
92 later devices descend from it; 3 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924018: M3 Lag Screw Fixation System, Osteomed Corp. (1993) Summary page 2.
- K924138: Osteomed M3 System (SBF System), Osteomed Corp. (1993) Summary page 2.
- K950595: Luhr Mandibular/Small Fixation Implants, Howmedica Corp. (1995) Summary page 2.
- K952272: TI. Alloy 2.0 MM Cortex Screw, Synthes (Usa) (1995) Summary page 2.

## Most influential descendants
- K070039: Memometal Fixos Screws (2007), 84 descendants of its own
- K120493: Mini Cannulated Headed and Headless Screw Set (2012), 39 descendants of its own
- K142658: Biomet Headless Compression and Twist-off Screws (2014), 36 descendants of its own
- K123890: Acumed Cannulated Screw System (2013), 36 descendants of its own
- K131722: I.T.S. Extremity Fixation Systems (2013), 24 descendants of its own

## Indications for use
The TWIST-OFF™ SCREW is indicated for fixing and stabilizing elective osteotomies of metatarsals and phalanges of the foot.

Source page: https://510kreport.com/device/K962233
Methodology: https://510kreport.com/methodology