510(k) Report

510(k) · Cleared

Cleared

Modification of the Bioplate Zip Craniotomy Fixation System

K020088510(k) SpecialCleared Feb 8, 200229-day reviewClass II21 CFR 882.5330

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

Bioplate, Inc. · GXN Plate, Cranioplasty, Preformed, Non-Alterable

Cleared on Feb 8, 2002 as substantially equivalent to K993990 (Stryker Instruments, 2000) and 6 other predicates after a 29-day review. Its family tree reaches back 4 generations to 1998. 2 later devices descend from it.

Decided
Feb 8, 2002
Review
29 days
Class
Class II
Product code
GXN
Recalls
None
Predicates
8

Its longest line of descent runs back 4 generations to K971252 (1998). 8 ancestors in all, the oldest K972332 (1998). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 2 other ancestors1998: 2 other ancestors2008: 1 descendant cleared2007: 1 descendant clearedK971252 · Sevrain Cranial Clamp · Ikonos Corp. · 1998K991029 · Rapidflap Cranial Clamp · Walter Lorenz Surgical, Inc. · 1999K993990 · Leibinger Quik Disk Titanium Clamp System · Stryker Instruments · 2000K013050 · The Bioplate Zip Craniotomy Fixation System · Bioplate, Inc. · 20011995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 2 descendants K013050 · The Bioplate Zip Craniotomy Fixation System · Bioplate, Inc. · 2001K993990 · Leibinger Quik Disk Titanium Clamp System · Stryker Instruments · 2000K991029 · Rapidflap Cranial Clamp · Walter Lorenz Surgical, Inc. · 1999K971252 · Sevrain Cranial Clamp · Ikonos Corp. · 19980
  1. Root · 4 generations backK971252 Sevrain Cranial ClampIkonos Corp. · 1998
  2. 3 generations backK991029 Rapidflap Cranial ClampWalter Lorenz Surgical, Inc. · 1999
  3. 2 generations backK993990 Leibinger Quik Disk Titanium Clamp SystemStryker Instruments · 2000
  4. 1 generation backK013050 The Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2001
  5. This deviceK020088 Modification of the Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2002
  6. Descendant · cites it directly · 1 of its ownK070901 Modified Plate Design for Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2007
  7. Descendant · cites it directly · 0 of its ownK082175 Mofication to: Modified Plate Design for Bioplate Zip Craniotomy…Bioplate, Inc. · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K070901Modified Plate Design for Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2007 · cites it directly1descendant
  • K082175Mofication to: Modified Plate Design for Bioplate Zip Craniotomy FixationBioplate, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K971252Sevrain Cranial ClampIkonos Corp.1998—
−3K991029Rapidflap Cranial ClampWalter Lorenz Surgical, Inc.1999—
−2K993990Leibinger Quik Disk Titanium Clamp SystemStryker Instruments2000—
−1K013050The Bioplate Zip Craniotomy Fixation SystemBioplate, Inc.2001—
0 (this device)K020088Modification of the Bioplate Zip Craniotomy Fixation SystemBioplate, Inc.2002—
+1K070901Modified Plate Design for Bioplate Zip Craniotomy Fixation SystemBioplate, Inc.2007—
+1K082175Mofication to: Modified Plate Design for Bioplate Zip Craniotomy FixationBioplate, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820
199920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
FIG. 1 — Lineage of K020088, 1998–2008Source: 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 GXN? 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 GXN device

  1. #1 K260709 ClearFit Ti Ring 14mm (171750);ClearFit Ti…score 13.7 · 8 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? (8)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K993990Leibinger Quik Disk Titanium Clamp System
Summary page 1
…fication name Plate, Cranioplasty, Preformed, Non-Alterable Device Classification 84GXN (21CFR - 882.5330) Predicate Devices (1) Stryker Instruments Leibinger Quik Disk K993990 (2) Synthes (USA) Synthes Cranial Flap Twist Clamp K991860 }COLO Y14 fl/a (3) Synthes (USA) Synthes Cranial F…
Stryker Instruments2000—
*K991860Synthes Cranial Flap Twist Clamp
Summary page 1
…Device Classification 84GXN (21CFR - 882.5330) Predicate Devices (1) Stryker Instruments Leibinger Quik Disk K993990 (2) Synthes (USA) Synthes Cranial Flap Twist Clamp K991860 }COLO Y14 fl/a (3) Synthes (USA) Synthes Cranial Flap Tube Clamp K992000 (4) Walter Lorenz Surgical Rapidflap…
Synthes (Usa)1999—
*K992000Synthes Cranial Flap Tube Clamp
Summary page 2
…ibinger Quik Disk K993990 (2) Synthes (USA) Synthes Cranial Flap Twist Clamp K991860 }COLO Y14 fl/a (3) Synthes (USA) Synthes Cranial Flap Tube Clamp K992000 (4) Walter Lorenz Surgical Rapidflap Cranial Clamp K991029 (8) lkonos Corp. Sevrain Cranial Clamp KS71252 (6) Ikonos Corp. S…
Synthes (Usa)19991
*K991029Rapidflap Cranial Clamp
Summary page 2
…Flap Twist Clamp K991860 }COLO Y14 fl/a (3) Synthes (USA) Synthes Cranial Flap Tube Clamp K992000 (4) Walter Lorenz Surgical Rapidflap Cranial Clamp K991029 (8) lkonos Corp. Sevrain Cranial Clamp KS71252 (6) Ikonos Corp. Sevrain Cranial Clamp SCC-200 Series Kg971408 (7) Aesculap,…
Walter Lorenz Surgical, Inc.1999—
Kept off the family treeK971252FDA’s K971252 is Sevrain Cranial Clamp
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Ikonos Corp.1998—
*K971408Sevrain Cranial Clamp (SCC-200 Series)
Summary page 2
…0 (4) Walter Lorenz Surgical Rapidflap Cranial Clamp K991029 (8) lkonos Corp. Sevrain Cranial Clamp KS71252 (6) Ikonos Corp. Sevrain Cranial Clamp SCC-200 Series Kg971408 (7) Aesculap, Inc. Aesculap Craniofix Titanium Clamp System K972332 (8) Bioplate, Inc. The Bioplate® ZIP™ Craniotomy Fixation…
Ikonos Corp.1998—
*K972332Aesculap Craniofix Titanium Clamp System
Summary page 2
…konos Corp. Sevrain Cranial Clamp KS71252 (6) Ikonos Corp. Sevrain Cranial Clamp SCC-200 Series Kg971408 (7) Aesculap, Inc. Aesculap Craniofix Titanium Clamp System K972332 (8) Bioplate, Inc. The Bioplate® ZIP™ Craniotomy Fixation System K013050 Description of the device The Bioplate® ZIP™ Craniot…
Aesculap, Inc.1998—
*K013050The Bioplate Zip Craniotomy Fixation System
Summary page 2
…l Clamp SCC-200 Series Kg971408 (7) Aesculap, Inc. Aesculap Craniofix Titanium Clamp System K972332 (8) Bioplate, Inc. The Bioplate® ZIP™ Craniotomy Fixation System K013050 Description of the device The Bioplate® ZIP™ Craniotomy Fixation System consists of two circular disks, in a parallel configura…
Bioplate, Inc.2001—

Also cleared against K993990: 2 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K070901Modified Plate Design for Bioplate Zip Craniotomy Fixation SystemBioplate, Inc.20071
K082175Mofication to: Modified Plate Design for Bioplate Zip Craniotomy FixationBioplate, Inc.20080

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 4 years and passes through 4 companies; a new generation was cleared every 10 months on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K070901 (Bioplate, Inc., 2007) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K993990.

How does its category compare?

All GXN devices

GXN Plate, Cranioplasty, Preformed, Non-Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXN

2in 2025

2007: 22008: 12011: 22012: 32013: 12014: 22015: 22016: 12017: 22018: 32020: 52021: 32022: 22023: 12024: 12025: 22026 (partial year): 4
2007high 5 (2020) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXN

69in 2021

2012: 102 days median2018: 199 days median2020: 33 days median2021: 69 days median2026 (partial year): 193 days median
2007high 199 (2018) · low 33 (2020)2026

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

Recalls per year · GXN

6in 2018

2018: 6
2007high 6 (2018) · low 0 (2007)2026

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

Adverse event reports per year · GXN

24in 2025

2007: 32008: 172009: 172010: 232011: 202012: 292013: 572014: 602015: 472016: 352017: 742018: 562019: 542020: 632021: 632022: 572023: 322024: 352025: 24
2007high 74 (2017) · low 3 (2007)2025

MAUDE reports naming product code GXN, 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
20072—03
20081—017
20090—017
20100—023
20112—020
20123102029
20131—057
20142—060
20152—047
20161—035
20172—074
20183199656
20190—054
2020533063
2021369063
20222—057
20231—032
20241—035
20252—024
202641930—

What is it indicated for?

The Bioplate® ZIP™ Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilized 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.

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 K993990

2 other devices cite the same predicate.

  • K030378Stryker Leibinger Cranial Fixation SystemStryker Instruments · 2003
  • K013050The Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2001

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 GXN

The GXN category page

  • K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm…Longeviti Neuro Solutions · 2026
  • K2531163D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA) · 2026
  • K252251Easymade-TICG Bio Co., Ltd. · 2026
  • K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd. · 2026
  • K243715Synthes Patient Specific ImplantsSynthes GmbH · 2025

https://510kreport.com/device/K020088 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020088: Modification of the Bioplate Zip Craniotomy Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020088

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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