# K121315: Stryker CMF Medpor Customized Implant

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 1, 2012 after 183 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
Longest line of descent: 4 generations back to K904111 (1990). 7 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083621: Medpor Customized Surgical Implant, Porex Surgical, Inc. (2009) Summary page 1.
- K103010: Stryker Patient Specific Polymer Implant, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2010) Summary page 1.
- K111065: Stryker (R) Patient Specific Polymer Implant, Howmedica Osteonics Corp. Dba Stryker Orthopeadics (2011)

## Most influential descendants
- K143173: Stryker CMF MEDPOR Customized Implant (2015), 4 descendants of its own
- K153508: Stryker CMF MEDPOR Customized Implant (2016), 2 descendants of its own
- K191916: Stryker CMF MEDPOR Priority Customized Implant Kit (2019), 1 descendant of its own
- K254233: MEDPOR Customized Implant Kit (2026), 0 descendants of its own
- K152463: SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant (2016), 0 descendants of its own

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

Source page: https://510kreport.com/device/K121315
Methodology: https://510kreport.com/methodology