# K040364: Medpor Craniofacial Implants with Embedded Titanium Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Porex Surgical, Inc.
- Decided: Jun 30, 2004 after 138 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
45 later devices descend from it; 3 cite it directly.
2 of 46 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) MEDPOR® Surgical Implant Material: named in the summary without a submission number
- (no number) MEDPOR® Barrier Implants: named in the summary without a submission number
- (no number) MEDPOR® Barrier Channel Implants: named in the summary without a submission number
- (no number) Other titanium bone meshes currently marketed: named in the summary without a submission number

## Most influential descendants
- K043133: Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant, Cerepor (2005), 43 descendants of its own
- K062280: Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste (2006), 38 descendants of its own
- K070093: Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, Actipaste (2007), 29 descendants of its own
- K082491: Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene & Ceretene (2008), 28 descendants of its own
- K091636: Ostene CT, Aoc CT, Osteotene, Ceretene (2009), 20 descendants of its own

## Recalls of this device
- Dec 29, 2021 · Class II · Z-0715-2022: Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.
- Dec 17, 2014 · Class II · Z-1093-2015: Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW - MTB - Left. The appropriate articles were actually included in the shipment. However, the
- Dec 16, 2011 · Not classified · Z-0922-2012: The template that is packaged with this implant was not packaged according to specification. The template was packaged in a single pouch instead of a double pouch.

## Indications for use
MEDPOR Biomaterial with Embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.

Source page: https://510kreport.com/device/K040364
Methodology: https://510kreport.com/methodology