# K032966: The Answer Screw Supplementation System

- Pathway: 510(k) (Traditional)
- Applicant: Simplicity Orthopedic Solutions, LLC
- Decided: Jan 13, 2004 after 112 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The device is intended to be used for internal fracture fixation of small and large bones. It is to be used in combination with 3.5mm diameter and 4.5 mm diameter stainless steel cortical bone screws. It is not intended for use in the attachment of screws or other devices to the posterior elements of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K032966
Methodology: https://510kreport.com/methodology