# K123668: Orthocord

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, Inc., A Johnson and Johnson Company
- Decided: Feb 26, 2013 after 89 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904436 (1990). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040004: Orthocord Suture, Depuy Mitek (2004) Summary page 1.
- K043298: Blue Orthocord Suture, Depuy Mitek (2004) Summary page 1.
- K071257: Mini Quickanchor and Quickanchor Plus with Orthocord, Depuy Mitek, A Johnson & Johnson Company (2007) Summary page 1.
- K080352: Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+ Anchor with #3-0 Orthocord Suture, Depuy Mitek, A Johnson & Johnson Company (2008) Summary page 1.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 1.
- K022715: Coated Vicryl Plus Antimicrobial (Polyglactin 910) Suture, ETHICON, Inc. (2002) Summary page 1.
- K122374: Arthrex Suture (Uhmwpe), Arthrex, Inc. (2012) Summary page 1.
- K071622: Arthrex Fiberwire, Arthrex, Inc. (2007) Summary page 1.
- K041553: Arthrex Suture Grafting Kit, Arthrex, Inc. (2004) Summary page 1.

## Indications for use
The Small Size ORTHOCORD® Suture is indicated for: ORTHOCORD Suture is indicated for use in general soft tissue approximation, and/or ligation, including orthopaedic procedures.

Source page: https://510kreport.com/device/K123668
Methodology: https://510kreport.com/methodology