# K142658: Biomet Headless Compression and Twist-off Screws

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Nov 13, 2014 after 56 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K792022 (1979). 13 ancestors in all.
36 later devices descend from it; 3 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062352: FRS Screw, DePuy Orthopaedics, Inc. (2006) Summary page 4.
- K971069: Twist-Off (TM) Screw, Landos, Inc. (1997) Summary page 4.
- K962233: Twist-Off Screw, Landos, Inc. (1996) Summary page 4.
- K082320: Darco Small Screw, Wrightmedicaltechnologyinc (2008) Summary page 4.
- K070039: Memometal Fixos Screws, Memometal Technologies (2007) Summary page 4.

## Most influential descendants
- K190586: Monster® Screw System (2019), 21 descendants of its own
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (2023), 8 descendants of its own
- K180541: DePuy Synthes 2.0 mm Quick Insertion Screws (2018), 8 descendants of its own
- K203011: Monster Screw System (2020), 6 descendants of its own

## Recalls of this device
- Mar 28, 2019 · Class II · Z-1303-2019: There is a potential of fracture, bending or shearing of the driver.
- Mar 28, 2019 · Class II · Z-1302-2019: There is a potential of fracture, bending or shearing of the driver.

## Indications for use
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.

Source page: https://510kreport.com/device/K142658
Methodology: https://510kreport.com/methodology