# K062570: Patient Contoured Mesh (PCM)

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Oct 31, 2006 after 61 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: 3 generations back to K904111 (1990). 7 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052871: Stryker Custom TI Implant, Stryker Leibinger (2005) Summary page 1.
- K053199: Synthes Patient Specific Cranial/Craniofacial Implant, Synthes (Usa) (2005) Summary page 1.
- K033868: Synthes (Usa) Patient Specific Cranial/Craniofacial Implants, Synthes (Usa) (2004) Summary page 1.

## Most influential descendants
- 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
- K161090: Cranial PSI (2017), 2 descendants of its own

## Indications for use
Patient Contoured Mesh (PCM) is intended to replace bony voids in mandibular, maxillofacial or craniofacial skeleton.

Source page: https://510kreport.com/device/K062570
Methodology: https://510kreport.com/methodology