# K111065: Stryker (R) Patient Specific Polymer Implant

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp. Dba Stryker Orthopeadics
- Decided: Jul 14, 2011 after 87 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904111 (1990). 6 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103010: Stryker Patient Specific Polymer Implant, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2010) Summary page 1.
- K083621: Medpor Customized Surgical Implant, Porex Surgical, Inc. (2009) Summary page 2.

## Most influential descendants
- 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
- K132519: Stryker Customized Mandible Recon Plate Kit (2013), 3 descendants of its own

## Indications for use
The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

Source page: https://510kreport.com/device/K111065
Methodology: https://510kreport.com/methodology