# K022665: Porous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks Including Epor, Biopor, Minopor & P-Hdpe

- Pathway: 510(k) (Traditional)
- Applicant: Hohenstein Enterprises, Inc.
- Decided: Oct 9, 2002 after 61 days
- Product code: KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction)
- Device class: 2
- Regulation: 21 CFR 878.3500
- 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 K922489 (1992). 1 ancestor in all.
46 later devices descend from it; 3 cite it directly.
2 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922489: Medpor Surg Implant Material:Prefor Cran/Fac Impla, Porex Technologies Corp. (1992) Summary page 2.

## 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
Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.

Source page: https://510kreport.com/device/K022665
Methodology: https://510kreport.com/methodology