# K033115: Orthodek

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Nov 17, 2003 after 48 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: 1 generation back to K974299 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974299: Panacryl, ETHICON, Inc. (1998) Summary page 2.

## Indications for use
Orthodek Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and /or ligation, and orthopedic uses including tendon and ligament repairs and reattachment to bone but not for use in ophthalmic, cardiovascular or neurological tissue. Orthodek suture is particularly useful where extended wound support (up to 6 months) is desirable.

Source page: https://510kreport.com/device/K033115
Methodology: https://510kreport.com/methodology