510(k) Report

510(k) · Cleared

Cleared

Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery

K023810510(k) SpecialCleared Dec 4, 200219-day reviewClass II21 CFR 872.4760

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bioplate, Inc. · JEY Plate, Bone

Cleared on Dec 4, 2002 as substantially equivalent to K021684 (Bioplate, Inc., 2002) and 4 other predicates after a 19-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.

Decided
Dec 4, 2002
Review
19 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K854886 (1986). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 2 other ancestors1997: 2 other ancestors1995: 3 other ancestors1994: 3 other ancestors1993: 1 other ancestor1992: 2 other ancestors1991: 2 other ancestors2005: 1 descendant clearedK854886 · Wuerzburg Titanium Mini Bone Plates & Bone Screws · Walter Lorenz Surgical, Inc. · 1986 · recalledK021684 · The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery · Bioplate, Inc. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 11 other ancestors 1 generation forward: 1 descendant K021684 · The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery · Bioplate, Inc. · 2002K854886 · Wuerzburg Titanium Mini Bone Plates & Bone Screws · Walter Lorenz Surgical, Inc. · 1986 · recalled0
  1. Root · 2 generations backK854886 Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc. · 1986 · Recalled
  2. 1 generation backK021684 The Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc. · 2002
  3. This deviceK023810 Modification to Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc. · 2002
  4. Descendant · cites it directly · 0 of its ownK051293 Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed…Ceremed, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation SystemCeremed, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K854886Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc.19861
−1K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.2002—
0 (this device)K023810Modification to Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc.2002—
+1K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation…Ceremed, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199220
199310
199430
199530
199720
199820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K023810, 1986–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JEY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JEY device

  1. #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.2002—
*K980983The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Summary page 1
…CraniomaxillofaciaI Surgery KO2 1684 Bioplate, Inc. BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K980983 Bioplate, Inc. BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K972463…
Biomedics1998—
*K972463The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Summary page 1
…Craniomaxillofacial Surgery K980983 Bioplate, Inc. BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K972463 (4) Bioplate, Inc. BioplateO Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery…
Biomedics1997—
*K953273Bioplate Rigid Fixation Bone Plating System
Summary page 2
…llofacial Surgery K972463 (4) Bioplate, Inc. BioplateO Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K953273 (5) Bioplate, Inc. Bioplat- Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K943071…
Biomedics1995—
*K943071The Titanium Fixation System
Summary page 2
…Craniomaxillofacial Surgery K953273 (5) Bioplate, Inc. Bioplat- Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K943071 Description of the device The modified plate designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating Syst…
Biomedics1995—

Also cleared against K021684: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation SystemCeremed, Inc.20050

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 16.4 years on median.
  • 2 of the 17 ancestors have a recall of any class.
  • Of its descendants, K051293 (Ceremed, Inc., 2005) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K021684.

How does its category compare?

All JEY devices

JEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JEY

2in 2025

2007: 92008: 72009: 42010: 62011: 52012: 102013: 82014: 62015: 72016: 12017: 52018: 72019: 62020: 62021: 42022: 52023: 22024: 52025: 22026 (partial year): 3
2007high 10 (2012) · low 1 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEY

159in 2024

2007: 115 days median2008: 84 days median2009: 121 days median2010: 199 days median2011: 75 days median2012: 194 days median2013: 126 days median2014: 223 days median2015: 160 days median2017: 190 days median2018: 255 days median2019: 163 days median2020: 198 days median2021: 299 days median2022: 135 days median2024: 159 days median2026 (partial year): 258 days median
2007high 299 (2021) · low 75 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JEY

1in 2020

2008: 32009: 62010: 852013: 12020: 1
2007high 85 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JEY

1,003in 2025

2007: 292008: 242009: 932010: 2152011: 2412012: 4282013: 7662014: 6162015: 7672016: 5582017: 5682018: 6082019: 5952020: 6802021: 4512022: 3442023: 4952024: 6962025: 1,003
2007high 1,003 (2025) · low 24 (2008)2025

MAUDE reports naming product code JEY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079115029
2008784324
20094121693
2010619985215
20115750241
2012101940428
201381261766
201462230616
201571600767
20161—0558
201751900568
201872550608
201961630595
202061981680
202142990451
202251350344
20232—0495
202451590696
20252—01,003
202632580—

What is it indicated for?

The modified plates designs for use with the BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Indications for use as stated in the FDA summary.

Also cleared against K021684

3 other devices cite the same predicate.

  • K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2006
  • K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation SystemCeremed, Inc. · 2005
  • K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2003

More from Bioplate, Inc.

23 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in JEY

The JEY category page

  • K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual…KLS-Martin L.P. · 2026
  • K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026
  • K252246Leforte MMF SystemJeil Medical Corporation · 2026
  • K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025
  • K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY · 2025

https://510kreport.com/device/K023810 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023810: Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023810

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026