# K100120: Alexis Orthopaedic Wound Retractor

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Apr 2, 2010 after 77 days
- Product code: KGW (Ring (Wound Protector), Drape Retention, Internal)
- Device class: 2
- Regulation: 21 CFR 878.4370
- 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 K062907 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062907: Alexis Wound Retractor, Applied Medical Resources (2007) Summary page 2.

## Indications for use
The Alexis Orthopaedic Wound Retractor is indicated for use to access the musculoskeletal system through an atraumatically retracted wound

Source page: https://510kreport.com/device/K100120
Methodology: https://510kreport.com/methodology