# K963118: Extremity Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Oct 10, 1996 after 59 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.
59 later devices descend from it; 1 cites it directly.
0 of 60 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) Synthes’ 3mm Cannulated Screw System: named in the summary without a submission number

## Most influential descendants
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis (2012), 58 descendants of its own
- K141784: Ortho Solutions Ultos Plating System (2014), 28 descendants of its own
- K131722: I.T.S. Extremity Fixation Systems (2013), 24 descendants of its own
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own
- K193222: Tyber Medical Anatomical Plating System (2020), 11 descendants of its own

## Indications for use
The 2.7mm Extremity Bone Screw is intended for fracture and osteotomy fixation of the upper and lowcr extremities. This screw is not intended for usage in the spine and is not for use with any available bone plates, washers, etc.

Source page: https://510kreport.com/device/K963118
Methodology: https://510kreport.com/methodology