# K023594: Teno Fix

- Pathway: 510(k) (Traditional)
- Applicant: Ortheon Medical, LLC
- Decided: May 15, 2003 after 202 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: 2 generations back to K931271 (1994). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 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.
- K991073: Acier Sutures, Cardio Thoracic Systems (1999) Summary page 1.
- (no number) Prolene sutures: named in the summary without a submission 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
- K203855: CoNextions TR Tendon Repair System (2022), 0 descendants 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

## Indications for use
The Ortheon Medical Ten0 Fixm Tendon Repair System is intended for the repair of severed or lacerated digital flexor tendons.

Source page: https://510kreport.com/device/K023594
Methodology: https://510kreport.com/methodology