# K101609: Self Retaining Soft Tissue Retractor

- Pathway: 510(k) (Traditional)
- Applicant: Koros USA, Inc.
- Decided: Dec 9, 2010 after 184 days
- Product code: LXH (Orthopedic Manual Surgical Instrument)
- Device class: 1
- Regulation: 21 CFR 888.4540
- 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
Device is intended for use in surgical Procedures to provide surgical access to the spine by placing the retractor in incision Prepared by the surgeon down towards the larnina.

Source page: https://510kreport.com/device/K101609
Methodology: https://510kreport.com/methodology