510(k) Report

510(k) · Cleared

Cleared

The Bioplate Resorbable Bone Plating System for Craniomaxillofacial Surgery, Biolactate

K994060510(k) TraditionalCleared Jan 24, 2001421-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 Jan 24, 2001 as substantially equivalent to K955729 (Poly-Medics,Inc., 1996) and 3 other predicates after a 421-day review. Its family tree reaches back 2 generations to 1996.

Decided
Jan 24, 2001
Review
421 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K955729 (1996). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 2 other ancestors1996: 2 other ancestorsK955729 · Lactosorb Trauma Plating System · Poly-Medics,Inc. · 1996 · recalledK974554 · Synthes Resorbable Fixation System · Synthes (Usa) · 19981996199820002002
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K974554 · Synthes Resorbable Fixation System · Synthes (Usa) · 1998K955729 · Lactosorb Trauma Plating System · Poly-Medics,Inc. · 1996 · recalled0
  1. Root · 2 generations backK955729 Lactosorb Trauma Plating SystemPoly-Medics,Inc. · 1996 · Recalled
  2. 1 generation backK974554 Synthes Resorbable Fixation SystemSynthes (Usa) · 1998
  3. This deviceK994060 The Bioplate Resorbable Bone Plating System for Craniomaxillofacial…Bioplate, Inc. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K955729Lactosorb Trauma Plating SystemPoly-Medics,Inc.19961
−1K974554Synthes Resorbable Fixation SystemSynthes (Usa)1998—
0 (this device)K994060The Bioplate Resorbable Bone Plating System for Craniomaxillofacial Surgery…Bioplate, Inc.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199820
FIG. 1 — Lineage of K994060, 1996–2001Source: 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? (4)

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
*K955729Lactosorb Trauma Plating System
Summary page 1
…The substantial equivalence of this device is demonstrated by its similarity in intended use, design, dimensions, and materials to the LactoSorb® Trauma Plating System (K955729), which is manufactured from 82:18 poly(L-lactide-co-glycolide)., the Synthes (U.S.A.) Resorbable Fixation System (K974554), whic…
Poly-Medics,Inc.19961
*K974554Synthes Resorbable Fixation System
Summary page 1
…rials to the LactoSorb® Trauma Plating System (K955729), which is manufactured from 82:18 poly(L-lactide-co-glycolide)., the Synthes (U.S.A.) Resorbable Fixation System (K974554), which is manufactured from 70:30 poly(L/DL-lactide), and the Howmedica Leibinger Resorbable Fixation System (K982531), manufact…
Synthes (Usa)1998—
*K982531Howmedica Leibinger Resorbable Fixation System
Summary page 1
…, the Synthes (U.S.A.) Resorbable Fixation System (K974554), which is manufactured from 70:30 poly(L/DL-lactide), and the Howmedica Leibinger Resorbable Fixation System (K982531), manufactured of material described in the 510(k) as "substantially equivalent to that used in the LactoSorb Device”. The devic…
Howmedica Corp.1998—
*K980983The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Summary page 1
…Device”. The device is also substantially equivalent in its intended use and design to the Bioplate® Rigid fixation Bone Plating System for Craniomaxillofacial Surgery (K980983), which is manufactured of non-resorbable titanium. (> o snvrc,,_"" HEAL; LA _/C DEPARTMENT OF HEALTH & HUMAN…
Biomedics1998—

Also cleared against K955729: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 5 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • 5 other devices also cite its predicate K955729.

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 Bioplate Resorbable Bone Plating System is intended for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for craniomaxillofacial indications in which resorbable fixation is desired. Plates and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs.

The resorbable plates and screws are intended for minimally load bearing fixation for the following indications:

Craniofacial fractures

Reconstructive procedures of the craniomaxillofacial skeleton

Cranial bone fixation

Brow lift procedures

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

Also cleared against K955729

5 other devices cite the same predicate.

  • K030425Lorenz Resorbable Distraction System or ExpanderWalter Lorenz Surgical, Inc. · 2004
  • K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
  • K972913Macropore Protective Sheet (Protego System)Pacific Materials and Interfaces · 1998
  • K972919Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift ScrewBionx Implants, Inc. · 1998
  • K974554Synthes Resorbable Fixation SystemSynthes (Usa) · 1998

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/K994060 · printed Nov 5, 2026

Cite this page

510(k) Report. “K994060: The Bioplate Resorbable Bone Plating System for Craniomaxillofacial Surgery, Biolactate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994060

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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