# K183472: DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Mar 13, 2019 after 89 days
- Product code: FTM (Mesh, Surgical)
- 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: 2 generations back to K922489 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051879: Synthes (Usa) Porous Polyethylene Implants, Synthes (Usa) (2005) Summary page 6.
- K040364: Medpor Craniofacial Implants with Embedded Titanium Mesh, Porex Surgical, Inc. (2004) Summary page 6.
- K952677: Medpor Barrier Surgical Implant Biomaterial, Porex Surgical, Inc. (1995) Summary page 6.
- K832283: Medpar Surgical Implants, Porex Medical (1984) Summary page 6.
- K022665: Porous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks Including Epor, Biopor, Minopor & P-Hdpe, Hohenstein Enterprises, Inc. (2002) Summary page 6.
- K041333: Synthes (Usa) Titanium Wire, Synthes (Usa) (2004) Summary page 8.
- K042606: Modification to:Synthes (Usa) Titanium Wire, Synthes (Usa) (2005) Summary page 10.
- (no number) Ethilon™ Nylon Suture: named in the summary without a submission number

## Indications for use
The DePuy Synthes Porous Polyethylene Implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma. The DePuy Synthes Titanium Wire is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair. The DePuy Synthes Titanium Wire With Barb is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.

Source page: https://510kreport.com/device/K183472
Methodology: https://510kreport.com/methodology