# K053158: Optilene Mesh LP

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jan 18, 2006 after 65 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- 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 K962530 (1996). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962530: Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh, ETHICON, Inc. (1996) Summary page 1.
- K001122: Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh, ETHICON, Inc. (2000) Summary page 1.

## Most influential descendants
- K061704: Optilene Mesh (2006), 4 descendants of its own
- K073579: Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNN (2008), 3 descendants of its own
- K131530: Dynamesh -Cicat (2013), 2 descendants of its own
- K161550: DynaMesh-VENTRAL (2016), 1 descendant of its own
- K182087: DynaMesh-POSTERIOR (2018), 0 descendants of its own

## Indications for use
Optilene Mesh LP is indicated for hernioplasty and repair of other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Source page: https://510kreport.com/device/K053158
Methodology: https://510kreport.com/methodology