510(k) Report

510(k) · Cleared

Cleared

The Bioplate Zip Craniotomy Fixation System

K013050510(k) TraditionalCleared Dec 10, 200190-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 Dec 10, 2001 as substantially equivalent to K993990 (Stryker Instruments, 2000) and 6 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1998. 4 later devices descend from it.

Decided
Dec 10, 2001
Review
90 days
Class
Class II
Product code
GXN
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K971252 (1998). 7 ancestors in all, the oldest K972332 (1998). 4 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 2 other ancestors1998: 2 other ancestors2008: 1 descendant cleared2005: 1 descendant cleared2002: 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 · 20001995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 4 descendants K993990 · 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 · 3 generations backK971252 Sevrain Cranial ClampIkonos Corp. · 1998
  2. 2 generations backK991029 Rapidflap Cranial ClampWalter Lorenz Surgical, Inc. · 1999
  3. 1 generation backK993990 Leibinger Quik Disk Titanium Clamp SystemStryker Instruments · 2000
  4. This deviceK013050 The Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2001
  5. Descendant · cites it directly · 2 of its ownK020088 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
  8. Descendant · cites it directly · 0 of its ownK051293 Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed…Ceremed, Inc. · 2005

Most influential descendants

Showing 4 of 4 · See all
  • K020088Modification of the Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2002 · cites it directly2descendants
  • 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
  • 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
−3K971252Sevrain Cranial ClampIkonos Corp.1998—
−2K991029Rapidflap Cranial ClampWalter Lorenz Surgical, Inc.1999—
−1K993990Leibinger Quik Disk Titanium Clamp SystemStryker Instruments2000—
0 (this device)K013050The Bioplate Zip Craniotomy Fixation SystemBioplate, Inc.2001—
+1K020088Modification 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—
+1K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation…Ceremed, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820
199920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200510
200710
200810
FIG. 1 — Lineage of K013050, 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? (7)

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
*K993990Leibinger Quik Disk Titanium Clamp System
Summary page 1
…on 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 (3) Synthes (USA) Synthes Cranial Flap Tube Clamp K992000 (4) Wa…
Stryker Instruments2000—
*K991860Synthes Cranial Flap Twist Clamp
Summary page 1
…Classification - 84GXN (21CFR - 882.5330) Predicate Devices (1) Stryker Instruments Leibinger Quik Disk K993990 (2) Synthes (USA) Synthes Cranial Flap Twist Clamp K991860 (3) Synthes (USA) Synthes Cranial Flap Tube Clamp K992000 (4) Walter Lorenz Surgical Rapidflap Cranial Clamp K991029 === Pag…
Synthes (Usa)1999—
*K992000Synthes Cranial Flap Tube Clamp
Summary page 1
…es (1) Stryker Instruments Leibinger Quik Disk K993990 (2) Synthes (USA) Synthes Cranial Flap Twist Clamp K991860 (3) Synthes (USA) Synthes Cranial Flap Tube Clamp K992000 (4) Walter Lorenz Surgical Rapidflap Cranial Clamp K991029 (5) lkonos Corp. Paf)e/ RD-C & Sevrain Cranial Clam…
Synthes (Usa)19991
*K991029Rapidflap Cranial Clamp
Summary page 1
…Synthes (USA) Synthes Cranial Flap Twist Clamp K991860 (3) Synthes (USA) Synthes Cranial Flap Tube Clamp K992000 (4) Walter Lorenz Surgical Rapidflap Cranial Clamp K991029 (5) lkonos Corp. Paf)e/ RD-C & Sevrain Cranial Clamp K971252 (6) Ikonos Corp. Sevrain Cranial Clamp SCC-200 S…
Walter Lorenz Surgical, Inc.1999—
*K971252Sevrain Cranial Clamp
Summary page 2
…nthes Cranial Flap Tube Clamp K992000 (4) Walter Lorenz Surgical Rapidflap Cranial Clamp K991029 (5) lkonos Corp. Paf)e/ RD-C & Sevrain Cranial Clamp K971252 (6) Ikonos Corp. Sevrain Cranial Clamp SCC-200 Series K971408 (7) Aesculap, Inc. Aesculap Craniofix Titanium Clamp System K9…
Ikonos Corp.1998—
*K971408Sevrain Cranial Clamp (SCC-200 Series)
Summary page 2
…l Rapidflap Cranial Clamp K991029 (5) lkonos Corp. Paf)e/ RD-C & Sevrain Cranial Clamp K971252 (6) Ikonos Corp. Sevrain Cranial Clamp SCC-200 Series K971408 (7) Aesculap, Inc. Aesculap Craniofix Titanium Clamp System K972332 Description of the device The Bioplate® ZIP™ Craniotomy F…
Ikonos Corp.1998—
*K972332Aesculap Craniofix Titanium Clamp System
Summary page 2
…f)e/ RD-C & Sevrain Cranial Clamp K971252 (6) Ikonos Corp. Sevrain Cranial Clamp SCC-200 Series K971408 (7) Aesculap, Inc. Aesculap Craniofix Titanium Clamp System K972332 Description of the device The Bioplate® ZIP™ Craniotomy Fixation System consists of two circular disks, in a parallel configura…
Aesculap, Inc.1998—

Also cleared against K993990: 2 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K020088Modification of the Bioplate Zip Craniotomy Fixation SystemBioplate, Inc.20022
K070901Modified Plate Design for Bioplate Zip Craniotomy Fixation SystemBioplate, Inc.20071
K082175Mofication to: Modified Plate Design for Bioplate Zip Craniotomy FixationBioplate, Inc.20080
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 3 years and passes through 4 companies; a new generation was cleared every 10 months on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K020088 (Bioplate, Inc., 2002) has gone furthest, with 2 descendants 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
  • K020088Modification of the Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2002

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/K013050 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013050: The Bioplate Zip 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/K013050

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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