# K140127: Ferrofibre Stainless Steel Suture with Crimp

- Pathway: 510(k) (Special)
- Applicant: Pontis Orthopaedics, LLC
- Decided: May 28, 2014 after 132 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: 5 generations back to K961555 (1996). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081060: Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5, Core Essence Orthopaedics, LLC (2008) Summary page 1.
- K101126: Pontis Sutures and Suture Anchors with Optional Crimps, Core Essence Orthopaedics, Inc. (2010) Summary page 1.

## Most influential descendants
- K143582: Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel (2015), 0 descendants of its own

## Indications for use
ferroFlBRETM Stainless Steel Suture are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerciage and tendon repair.

Source page: https://510kreport.com/device/K140127
Methodology: https://510kreport.com/methodology