# K082178: Tephaflex Absorbable Suture

- Pathway: 510(k) (Traditional)
- Applicant: Tepha, Inc.
- Decided: Oct 30, 2008 after 90 days
- Product code: NWJ (Suture, Recombinant Technology)
- Device class: 2
- Regulation: 21 CFR 878.4494
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TephaFLEX Absorbable Suture: named in the summary without a submission number
- (no number) BioElast Absorbable suture: named in the summary without a submission number
- (no number) PDS II Absorbable Suture: named in the summary without a submission number

## Most influential descendants
- K122487: Biofiber Syture (2012), 2 descendants of its own
- K130422: Phantom Fiber Biofiber Suture (2013), 1 descendant of its own
- K211307: GalaSTITCH Absorbable Monofilament Suture (2021), 0 descendants of its own
- K132348: Tephaflex Braided Suture (2013), 0 descendants of its own
- K100876: Aesculap Monomax Absorbable Suture (2010), 0 descendants of its own

## Indications for use
TephaFLEX absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Source page: https://510kreport.com/device/K082178
Methodology: https://510kreport.com/methodology