# K043176: Arc Surgical Resorbable Compression Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Arc Surgical, LLC
- Decided: Jun 17, 2005 after 213 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 K992301 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032098: Arthrex Bio-Compression Screw, Small, Arthrex Bio-Compression Screw, Large, Models AR-5024B, AR-5025B, Arthrex, Inc. (2003) Summary page 1.
- K003077: Smartscrew Model 222006...227510, Bionx Implants, Ltd. (2001) Summary page 1.
- K992301: Reunite Screws, Biomet Manufacturing, Inc. (1999) Summary page 1.

## Indications for use
The Arc Surgical Resorbable Compression Screw System is intended to fix osteochondral fragments, osteotomies and fractures in the foot, and limited fractures in the wrist, elbow, and ankle, as listed: * Osteochondral fragments o Femoral condyle o Talus o Navicular * Hallux Valgus correction * Tarsal fractures * Distal Radius fractures * Radial Head fractures

Source page: https://510kreport.com/device/K043176
Methodology: https://510kreport.com/methodology