510(k) Report

510(k) · Cleared

Cleared

The Bioplate Bioclip Craniotomy Fixation System

K013055510(k) TraditionalCleared Dec 7, 200187-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 7, 2001 as substantially equivalent to K001530 (Bioplate, Inc., 2000) and 2 other predicates after an 87-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided
Dec 7, 2001
Review
87 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K001530 (2000). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 1 other ancestor2005: 1 descendant clearedK001530 · The Bioplate Bioclip Craniotomy Fixation System · Bioplate, Inc. · 2000200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K001530 · The Bioplate Bioclip Craniotomy Fixation System · Bioplate, Inc. · 20000
  1. Root · 1 generation backK001530 The Bioplate Bioclip Craniotomy Fixation SystemBioplate, Inc. · 2000
  2. This deviceK013055 The Bioplate Bioclip Craniotomy Fixation SystemBioplate, Inc. · 2001
  3. 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
−1K001530The Bioplate Bioclip Craniotomy Fixation SystemBioplate, Inc.2000—
0 (this device)K013055The Bioplate Bioclip Craniotomy Fixation SystemBioplate, Inc.2001—
+1K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation…Ceremed, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K013055, 2000–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K001530The Bioplate Bioclip Craniotomy Fixation System
Summary page 1
…nhame Bone Plate lassification nam Bone Plate Device Classification 76 JEY (21CFR - 872.4760) " Predicate Devices The Bioplate® Bioclip® Craniotomy Fixation System -(K001530) (K002879) (K011380) Description of the device The Bioplate® Bioclip® Craniotomy Fixation System consists of a bone plate manuf…
Bioplate, Inc.2000—
*K002879Modification to Bioplate Bioclip Craniotomy Fixation System
Summary page 1
…ne Plate lassification nam Bone Plate Device Classification 76 JEY (21CFR - 872.4760) " Predicate Devices The Bioplate® Bioclip® Craniotomy Fixation System -(K001530) (K002879) (K011380) Description of the device The Bioplate® Bioclip® Craniotomy Fixation System consists of a bone plate manufactured of…
Bioplate, Inc.2000—
*K011380Modification to the Bioplate Bioclip Craniotomy Fixation System
Summary page 1
…assification nam Bone Plate Device Classification 76 JEY (21CFR - 872.4760) " Predicate Devices The Bioplate® Bioclip® Craniotomy Fixation System -(K001530) (K002879) (K011380) Description of the device The Bioplate® Bioclip® Craniotomy Fixation System consists of a bone plate manufactured of 6Al 4V ti…
Bioplate, Inc.2001—

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K051293 (Ceremed, Inc., 2005) has gone furthest, with 0 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 Bioplate® Bioclip® Craniotomy Fixation System is intended to re-attach a cranial bone flap following a craniotomy procedure. The clip/plate is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

The Bioplate® Bioclip® Craniotomy Fixation System is contraindicated in the following conditions:

The gap in the cranial bone is greater than 2.5mm for standard sizes.

The gap in the cranial bone is greater than 4mm for XT sizes.

The skull thickness is less than 4.5mm

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

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/K013055 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013055: The Bioplate Bioclip Craniotomy Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013055

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026