# K143172: ACL SMART System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 4, 2015 after 92 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K792022 (1979). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980155: Endobutton Continuous Loop, Smith & Nephew, Inc. (1998) Summary page 5.
- K081098: Endobutton Continuous Loop (CL), Smith & Nephew Inc., Endoscopy Division (2008) Summary page 5.
- K040542: Smith & Nephew GTS Sleeve and GTS Tapered Screw, Smith & Nephew, Inc. (2004) Summary page 5.
- K992396: Biorci Screw, Smith & Nephew Endoscopy, Inc. (2000) Summary page 5.
- K032224: Biorci Screw, Smith & Nephew, Inc. (2003) Summary page 5.

## Indications for use
The Smith & Nephew ACL SMART System is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K143172
Methodology: https://510kreport.com/methodology