510(k) Report

510(k) · Cleared

Cleared

The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery

K972463510(k) TraditionalCleared Sep 25, 199786-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

Biomedics · JEY Plate, Bone

Cleared on Sep 25, 1997 after an 86-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.

Decided
Sep 25, 1997
Review
86 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
0

14 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2006: 1 descendant cleared2005: 1 descendant cleared2003: 2 descendants cleared2002: 2 descendants cleared2010: 2 descendants cleared2008: 1 descendant cleared2018: 1 descendant cleared2013: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK972463 The Bioplate Rigid Fixation Bone Plating System for…Biomedics · 1997
  2. Descendant · cites it directly · 7 of its ownK022890 Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone…Bioplate, Inc. · 2002
  3. Descendant · cites it directly · 5 of its ownK030806 Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc. · 2003
  4. Descendant · 2 generations on · 4 of its ownK091812 Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic…Frontier Devices, Inc. · 2010
  5. Descendant · cites it directly · 3 of its ownK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
  6. Descendant · cites it directly · 3 of its ownK062819 Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2006

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2002: 22003: 22005: 12006: 12008: 12010: 22013: 12014: 12018: 12020: 12023: 1
2002high 2 (2002) · low 0 (2004)2026

Most influential descendants

Showing 5 of 14 · See all
  • K022890Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc. · 2002 · cites it directly7descendants
  • K030806Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2003 · cites it directly5descendants
  • K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc. · 2010 · 2 generations on4descendants
  • K141764Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014 · cites it directly3descendants
  • K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2006 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K972463The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBiomedics1997—
+1K022890Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating…Bioplate, Inc.2002—
+1K030806Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.2003—
+2K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.2010—
+1K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.2014—
+1K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200320
200510
200610
200810
201020
201310
201410
201810
202010
202310
FIG. 1 — Lineage of K972463, 1997–2023Source: 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? (3)

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
*—Biomedics, Inc.
Named without a submission number
—
*—W.L. Lorenz
Named without a submission number
—
*—Synthes (USA.)
Named without a submission number
—

What descends from it? (14)

See all 14

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022890Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc.20027
K030806Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20035
K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143
K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20063
K023810Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc.20021
K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation SystemCeremed, Inc.20050
K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20030

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?

  • Of its descendants, K022890 (Bioplate, Inc., 2002) has gone furthest, with 7 descendants of its own.

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 plate and screw designs for use in conjunction with the I}ioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the facial skeleton and qon-}oaq bearing fixation, _lncludmg crania bone fixation, brow fixation, zygomatic fixation, orbital rim fixation , maxilary fixation, gratft fixation and membrane fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Biomedics

10 FDA decisions under this applicant name. See the company

  • K992330The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBiomedics · 1999
  • K984583The Bioplate Shunt ConnectorBiomedics · 1999
  • K980983The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBiomedics · 1998
  • K961976The Bioplate Fixation SystemBiomedics · 1996
  • K953273Bioplate Rigid Fixation Bone Plating SystemBiomedics · 1995

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/K972463 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972463: The 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 4, 2026. https://510kreport.com/device/K972463

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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