# K012350: Medpor Plus Surgical Implant Biomaterial

- Pathway: 510(k) (Traditional)
- Applicant: Porex Surgical, Inc.
- Decided: Mar 14, 2002 after 232 days
- Product code: FWP (Prosthesis, Chin, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
44 later devices descend from it; 1 cites it directly.
2 of 45 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) Bioglass® Synthetic Bone Graft Particulate: 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

## Indications for use
MEDPOR® Plus Surgical Implants in block, sheet and preformed shapes are intended for the augmentation or restoration of contour in craniofacial applications.

Source page: https://510kreport.com/device/K012350
Methodology: https://510kreport.com/methodology