# K103010: Stryker Patient Specific Polymer Implant

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Oct 26, 2010 after 14 days
- Product code: KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction)
- Device class: 2
- Regulation: 21 CFR 878.3500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904111 (1990). 3 ancestors in all.
23 later devices descend from it; 3 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)
- K043250: Stryker Patient Specific Polymer Implant, Stryker Leibinger (2005) Summary page 2.

## 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

## Recalls of this device
- Dec 6, 2013 · Class II · Z-0975-2014: Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.

## 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/K103010
Methodology: https://510kreport.com/methodology