# K922489: Medpor Surg Implant Material:Prefor Cran/Fac Impla

- Pathway: 510(k) (Traditional)
- Applicant: Porex Technologies Corp.
- Decided: Sep 2, 1992 after 98 days
- Product code: FWP (Prosthesis, Chin, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
132 later devices descend from it; 9 cite it directly.
2 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K970400: Bone Source Hydroxyapatite (1997), 50 descendants of its own
- K973789: Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System (CRS) Bone Cement- 10CC (1998), 49 descendants of its own
- K022665: Porous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks Including Epor, Biopor, Minopor & P-Hdpe (2002), 46 descendants of its own
- K991398: Bonesource Hydroxyapatite Cement (Hac) Expanded Kit (1999), 45 descendants of its own
- K043133: Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant, Cerepor (2005), 43 descendants of its own

## Recalls of this device
- Dec 17, 2014 · Class II · Z-1090-2015: Potential for implant damage, implant cracking off/breaking intra-operatively.

Source page: https://510kreport.com/device/K922489
Methodology: https://510kreport.com/methodology