# K042233: Passing Needle with Ethibond, Panacryl or Orthocord Suture

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Sep 28, 2004 after 41 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- 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 K010673 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964345: Ethicon Absorbable Poly (L-Lactide/Glycolide) Surgical Suture, Undyed, ETHICON, Inc. (1996) Summary page 1.
- K040004: Orthocord Suture, Depuy Mitek (2004) Summary page 1.
- K041806: Passing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle with Ethibond Loop, Depuy Mitek, A Johnson & Johnson Company (2004) Summary page 2.
- (no number) ETHIBOND sutures: named in the summary without a submission number

## Indications for use
Passing Needle with ETHIBOND. PANACRYL or ORTHCORD suture is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction..

Source page: https://510kreport.com/device/K042233
Methodology: https://510kreport.com/methodology