# K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jan 9, 1995 after 21 days
- Product code: GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile)
- Device class: 2
- Regulation: 21 CFR 878.4495
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
155 later devices descend from it; 19 cite it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K110789: Synthes Sternal Zipfix System (2011), 85 descendants of its own
- K111908: Biomet Microfixation Sternal Closure System (2011), 78 descendants of its own
- K121302: Biomet Microfixation Sternal Closure System (2012), 75 descendants of its own
- K122293: Pioneer Sternal Cable Plate System (2012), 46 descendants of its own
- K151983: KLS Martin LSS Plating System (2016), 45 descendants of its own

## Recalls of this device
- Sep 23, 2026 · Not classified · Z-0284-2027: Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vesse
- Sep 8, 2026 · Class II · Z-0153-2027: Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surg
- Mar 7, 2025 · Class II · Z-1516-2025: Identified curing issues with the silicone during the needles manufacturing process.
- Dec 20, 2024 · Class II · Z-1097-2025: Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to t
- Jun 10, 2020 · Class II · Z-2486-2020: Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
- Apr 19, 2019 · Class II · Z-1842-2019: Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
- Apr 19, 2019 · Class II · Z-1841-2019: Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
- Dec 18, 2018 · Class II · Z-0747-2019: The sutures inside the packaging are not the same size or type as indicated on the label.
- May 8, 2015 · Class II · Z-1839-2015: Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.
- Oct 17, 2014 · Class II · Z-0492-2015: Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.

Source page: https://510kreport.com/device/K946173
Methodology: https://510kreport.com/methodology