# K051293: Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ceremed, Inc.
- Decided: Jun 14, 2005 after 27 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K971252 (1998). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023810: Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Bioplate, Inc. (2002) Summary page 1.
- K021684: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Bioplate, Inc. (2002) Summary page 1.
- K013055: The Bioplate Bioclip Craniotomy Fixation System, Bioplate, Inc. (2001) Summary page 1.
- K013050: The Bioplate Zip Craniotomy Fixation System, Bioplate, Inc. (2001) Summary page 1.
- K011380: Modification to the Bioplate Bioclip Craniotomy Fixation System, Bioplate, Inc. (2001) Summary page 1.
- K992330: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Biomedics (1999) Summary page 2.
- K972463: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Biomedics (1997) Summary page 2.
- K953273: Bioplate Rigid Fixation Bone Plating System, Biomedics (1995) Summary page 2.
- K943071: The Titanium Fixation System, Biomedics (1995) Summary page 2.

## Cited in the summary but kept off the family tree
- K020880: Marknew Products Acupuncture Needles, Marknew Products (2002). Our reading of the summary gave K020880, FDA’s number for Marknew Products Acupuncture Needles (Marknew Products). Its FDA name has none of the distinctive words the summary uses for the device it names, “Zip Craniotomy Fixation System”. Kept off the family tree. Summary page 1.

## Indications for use
The CranionTM Cranial Fixation System intended for reconstruction of the craniomaxillofacial skeleton and for reattachment of cranial bone flaps after craniotomy procedures. The system is used to align and stabilized bony tissue while normal healing occurs. Each implantable component is intended for single use only and may be combined only with other titanium and titanium alloy implants.

Source page: https://510kreport.com/device/K051293
Methodology: https://510kreport.com/methodology