# K050947: Modification to: Modified Uss Polypropylene Suture

- Pathway: 510(k) (Special)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Jun 1, 2005 after 47 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954808 (1996). 2 ancestors in all.
76 later devices descend from it; 3 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954808: Ussc Polyproplene Suture, United States Surgical, A Division of Tyco Healthc (1996) Summary page 1.
- K010909: Nonabsorbable Polypropylene Surgical Suture, Tyco Healthcare Group LP (2001)

## Most influential descendants
- K063778: Force Fiber Polyethylene Nonabsorbable Suture (2007), 69 descendants of its own
- K092533: Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures (2009), 29 descendants of its own
- K070673: Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture (2007), 23 descendants of its own
- K100006: HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need (2010), 15 descendants of its own
- K150438: Force Fiber OrthoTape suture (2015), 14 descendants of its own

## Recalls of this device
- Jun 24, 2026 · Class II · Z-2922-2026: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalm
- Dec 2, 2022 · Class II · Z-1180-2023: Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

## Indications for use
Modified USS polypropylene sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.

Source page: https://510kreport.com/device/K050947
Methodology: https://510kreport.com/methodology