# K083621: Medpor Customized Surgical Implant

- Pathway: 510(k) (Traditional)
- Applicant: Porex Surgical, Inc.
- Decided: Feb 3, 2009 after 57 days
- Product code: JOF (Polymer, Ent Synthetic, Porous Polyethylene)
- Device class: 2
- Regulation: 21 CFR 874.3620
- 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.
29 later devices descend from it; 5 cite it directly.
0 of 31 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 1.

## Most influential descendants
- K111065: Stryker (R) Patient Specific Polymer Implant (2011), 20 descendants of its own
- K121153: Peek Customized Craial Implant Kit (2012), 13 descendants of its own
- K121315: Stryker CMF Medpor Customized Implant (2012), 5 descendants of its own
- K182711: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (2019), 4 descendants of its own
- K143173: Stryker CMF MEDPOR Customized Implant (2015), 4 descendants of its own

## Indications for use
The MEDPOR Customized Surgical Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

Source page: https://510kreport.com/device/K083621
Methodology: https://510kreport.com/methodology