# K971069: Twist-Off (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.
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 Twist-off Screw: named in the summary without a submission number
- (no number) Howmedica Luhr Screw System: named in the summary without a submission number
- (no number) Synthes Cortex Screw: named in the summary without a submission number
- (no number) Osteomed M3 Screw: named in the summary without a submission number

## Most influential descendants
- K142658: Biomet Headless Compression and Twist-off Screws (2014), 36 descendants of its own
- K190586: Monster® Screw System (2019), 21 descendants of its own
- K023365: Leforte System Bone Screw (2003), 20 descendants of its own
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K131311: Arix Foot System (2013), 9 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/K971069
Methodology: https://510kreport.com/methodology