# K924935: Hard Tissue Replace (HTR (R))-Patient-Match Implant

- Pathway: 510(k) (Traditional)
- Applicant: Polyclinic Medical Center
- Decided: Sep 2, 1993 after 337 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
No predicates in its family tree.
51 later devices descend from it; 2 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K043250: Stryker Patient Specific Polymer Implant (2005), 50 descendants of its own
- 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

## Recalls of this device
- Jun 13, 2016 · Class II · Z-2751-2016: Potential sterility deficiency.

Source page: https://510kreport.com/device/K924935
Methodology: https://510kreport.com/methodology