# K041894: Orthofiber

- Pathway: 510(k) (Special)
- Applicant: Cp Medical
- Decided: Sep 17, 2004 after 66 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K990088 (1999). 8 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001172: Polyester Nonabsorbable Surgical Sutures Urp, Cp Medical (2000) Summary page 1.
- K010673: Arthrex Fiberwire, Model Spu-02NB-3800, Arthrex, Inc. (2001) Summary page 1.
- K021434: Arthrex Fiberwire in Usp Sizes, Arthrex, Inc. (2002) Summary page 1.

## Most influential descendants
- K094028: CP-Fiber (Orthofiber) (2010), 0 descendants of its own
- K082518: Dual Needle Suture Passer System (2009), 0 descendants of its own
- K071796: Capsew Plication System (2007), 0 descendants of its own
- K050150: Mani Needle & Suture Pack (2005), 0 descendants of its own

## Indications for use
General soft tissue approximation including use in cardiovascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K041894
Methodology: https://510kreport.com/methodology