510(k) Report

FDA applicant

Bioplate, Inc.

Los Angeles, CA23 decisions2000–20082 recalls

FDA records 23 decisions for Bioplate, Inc. (Los Angeles, CA) from 2000 to 2008: 23 510(k) clearances. Most are in product codes JEY (Plate, Bone) and GXN (Plate, Cranioplasty, Preformed, Non-Alterable). Its devices cite 109 predicates, 16 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Bioplate, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2007: 12008: 2
2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bioplate, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bioplate, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JEYPlate, Bone16decisions
  • GXNPlate, Cranioplasty, Preformed, Non-Alterable5decisions
  • DZLScrew, Fixation, Intraosseous1decision
  • HBCMotor, Drill, Electric1decision

Whose devices does it build on?

Its devices cite 109 predicates; 16 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 28 times; 16 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K013050The Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 20014cite it
  • K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 20024cite it
  • K022890Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc. · 20023cite it
  • K011380Modification to the Bioplate Bioclip Craniotomy Fixation SystemBioplate, Inc. · 20012cite it
  • K020088Modification of the Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 20022cite it
  • K030806Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 20032cite it

What has FDA decided for it lately?

  • K082757Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium Fixation SystemBioplate, Inc. · 20081 recall
  • K082175Mofication to: Modified Plate Design for Bioplate Zip Craniotomy FixationBioplate, Inc. · 2008
  • K070901Modified Plate Design for Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2007
  • K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2006
  • K051845The Bioplate Resorbable Endobrow Fixation SystemBioplate, Inc. · 20051 recall
  • K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2003
  • K030806Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2003
  • K023810Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2002

All 23 as Bioplate, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K082757Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit…Mar 31, 2010
  • K051845Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45Sep 12, 2006