# K230655: PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: May 3, 2023 after 55 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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: 8 generations back to K961555 (1996). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083635: Smith & Nephew Biosure PK Interference Screw, Smith & Nephew Endoscopy, Inc. (2009) Summary page 4.
- K032224: Biorci Screw, Smith & Nephew, Inc. (2003) Summary page 4.
- K142230: Apollo Suture Anchor System and Titan Screws, Valeris Medical (2014) Summary page 4.

## Indications for use
The Signature Orthopaedics PEEK RCI, Bio-Composite and SignaLoc Screws are RCI screws intended for use in fixation of soft tissue including ligament or tendon to bone for cruciate ligament reconstruction surgeries of the knee. The screws are also intended for use in the following procedures: • ACL repairs • PCL repairs • Extra-capsular repairs • Medial collateral ligament • Lateral collateral ligament • Posterior oblique ligament • Patellar realignment and tendon repairs • Vastus medialis obliquus advancement • Illiotibial band tenodesis

Source page: https://510kreport.com/device/K230655
Methodology: https://510kreport.com/methodology