# K051845: The Bioplate Resorbable Endobrow Fixation System

- Pathway: 510(k) (Special)
- Applicant: Bioplate, Inc.
- Decided: Jul 27, 2005 after 20 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K012908 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012908: Bioplate Resorbable Bone Screw, Bioplate, Inc. (2001) Summary page 2.

## Cited in the summary but kept off the family tree
- K996040: The Bioplate Resorbable Bone Plating System For Craniomaxillofacial Surgery, Biolactate TM. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K061507: Sonicweld RX Endobrow Fixation (2006), 0 descendants of its own

## Recalls of this device
- Sep 12, 2006 · Not classified · Z-0043-2007: Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.

## Indications for use
The Bioplate Resorbable Bone Fixation Tack will be used to support non-load bearing tissues of the craniomaxillofacial anatomy, including but not limited to brow fixation.

Source page: https://510kreport.com/device/K051845
Methodology: https://510kreport.com/methodology