# K081060: Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5

- Pathway: 510(k) (Abbreviated)
- Applicant: Core Essence Orthopaedics, LLC
- Decided: Dec 24, 2008 after 254 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- 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
- K143582: Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel (2015), 0 descendants of its own
- K141711: Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis Ultra-High Molecular Weight Polye (2014), 0 descendants of its own
- K133579: Multifilament Stainless Steel Sutures with Crimps (2014), 0 descendants of its own

## Indications for use
ferroFibre TM Stainless Steel Sutures are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.

Source page: https://510kreport.com/device/K081060
Methodology: https://510kreport.com/methodology