# K052871: Stryker Custom TI Implant

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger
- Decided: Dec 16, 2005 after 66 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904111 (1990). 4 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 23 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 1.
- K033868: Synthes (Usa) Patient Specific Cranial/Craniofacial Implants, Synthes (Usa) (2004) Summary page 1.

## Most influential descendants
- K062570: Patient Contoured Mesh (PCM) (2006), 17 descendants of its own
- K072707: Patient Contoured Mesh-Peek (PCM-P) (2007), 13 descendants of its own
- K103582: Kelyniam Custom Skull Implant (Csi) (2011), 8 descendants of its own
- K121755: Custom Craniofacial Implant (Cci) (2012), 5 descendants of its own
- K182711: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (2019), 4 descendants of its own

## Indications for use
The Stryker®3 Custom Ti 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/K052871
Methodology: https://510kreport.com/methodology