# K991073: Acier Sutures

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Thoracic Systems
- Decided: Jul 30, 1999 after 121 days
- Product code: GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile)
- Device class: 2
- Regulation: 21 CFR 878.4495
- 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 K931271 (1994). 1 ancestor in all.
11 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931271: Ethi-Pack* Surgical Stainless Steel Suture, ETHICON, Inc. (1994) Summary page 1.

## Most influential descendants
- K023594: Teno Fix (2003), 5 descendants of its own
- K023411: Steelex Sternum Set (2002), 4 descendants of its own
- K101126: Pontis Sutures and Suture Anchors with Optional Crimps (2010), 3 descendants of its own
- K140127: Ferrofibre Stainless Steel Suture with Crimp (2014), 1 descendant of its own
- K063603: Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 (2007), 1 descendant of its own

## Indications for use
Acier Surgical Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure, and certain orthopedic procedures including cerclage and tendon repair.

Source page: https://510kreport.com/device/K991073
Methodology: https://510kreport.com/methodology