# K043250: Stryker Patient Specific Polymer Implant

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger
- Decided: Apr 15, 2005 after 143 days
- Product code: KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction)
- Device class: 2
- Regulation: 21 CFR 878.3500
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904111 (1990). 2 ancestors in all.
50 later devices descend from it; 4 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924935: Hard Tissue Replace (HTR (R))-Patient-Match Implant, Polyclinic Medical Center (1993) Summary page 1.
- K904111: HTR Polymer, HTR-MX, United States Surgical, A Division of Tyco Healthc (1990) Summary page 1.
- (no number) Hard Tissue Replacement - Malleable Facial Implant: named in the summary without a submission number
- (no number) Surgical Simplex P Radiopaque Bone Cement: named in the summary without a submission number

## Most influential descendants
- K103010: Stryker Patient Specific Polymer Implant (2010), 23 descendants of its own
- K111065: Stryker (R) Patient Specific Polymer Implant (2011), 20 descendants of its own
- K072601: Osteosymbionics Patient Specific Cranial Implant (2007), 20 descendants of its own
- K052871: Stryker Custom TI Implant (2005), 18 descendants of its own
- K062570: Patient Contoured Mesh (PCM) (2006), 17 descendants of its own

## Recalls of this device
- Oct 24, 2008 · Not classified · Z-0510-2009: Lack of assurance of sterility.
- Oct 24, 2008 · Not classified · Z-0512-2009: Lack of assurance of sterility.
- Oct 24, 2008 · Not classified · Z-0509-2009: Lack of assurance of sterility.
- Oct 24, 2008 · Not classified · Z-0511-2009: Lack of assurance of sterility.

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

Source page: https://510kreport.com/device/K043250
Methodology: https://510kreport.com/methodology