510(k) Report

510(k) · Cleared

Cleared

Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery

K062819510(k) TraditionalCleared Dec 4, 200675-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 4, 2006 as substantially equivalent to K021684 (Bioplate, Inc., 2002) and 7 other predicates after a 75-day review. Its family tree reaches back 2 generations to 1986. 3 later devices descend from it.

Decided
Dec 4, 2006
Review
75 days
Class
Class II
Product code
GXN
Recalls
None
Predicates
8

Its longest line of descent runs back 2 generations to K854886 (1986). 18 ancestors in all. 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1998: 2 other ancestors1997: 2 other ancestors1995: 3 other ancestors1991: 2 other ancestors1994: 3 other ancestors1993: 1 other ancestor1992: 2 other ancestors2008: 1 descendant cleared2013: 1 descendant cleared2010: 1 descendant clearedK854886 · Wuerzburg Titanium Mini Bone Plates & Bone Screws · Walter Lorenz Surgical, Inc. · 1986 · recalledK021684 · The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery · Bioplate, Inc. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 10 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants K021684 · The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery · Bioplate, Inc. · 2002K854886 · Wuerzburg Titanium Mini Bone Plates & Bone Screws · Walter Lorenz Surgical, Inc. · 1986 · recalled0
  1. Root · 2 generations backK854886 Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc. · 1986 · Recalled
  2. 1 generation backK021684 The Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc. · 2002
  3. This deviceK062819 Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2006
  4. Descendant · cites it directly · 2 of its ownK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
  5. Descendant · 2 generations on · 0 of its ownK121606 Resorb-X GKLS-Martin L.P. · 2013
  6. Descendant · 2 generations on · 0 of its ownK101835 Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010

Most influential descendants

Showing 3 of 3 · See all
  • K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008 · cites it directly2descendants
  • K121606Resorb-X GKLS-Martin L.P. · 2013 · 2 generations on0descendants
  • K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K854886Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc.19861
−1K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.2002—
0 (this device)K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.2006—
+1K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.2008—
+2K121606Resorb-X GKLS-Martin L.P.2013—
+2K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199220
199310
199430
199530
199720
199820
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201310
FIG. 1 — Lineage of K062819, 1986–2013Source: 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 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.

TypeNumberDeviceApplicantDecidedRecalls
*K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Our reading of the summary gave K021864, FDA’s number for Primagard Nonsterile Femoral Angiography Drapes (Models… (Primeline Medical Products, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Modified Plate designs for use with the Bioplate® Rigid Fixation…”.
Bioplate, Inc.2002—
*K992330The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Summary page 1
…lofacial Surgery (K021864) Plate designs for use in conjunction with the Bioplate® Rigid Fixation Bone plating System for Craniomaxillofacial Surgery (K992330) The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K980983). The Bioplate® Ri…
Biomedics1999—
*K980983The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Summary page 1
…xation Bone plating System for Craniomaxillofacial Surgery (K992330) The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K980983). The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K972463).…
Biomedics1998—
*K972463The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Summary page 1
…ation Bone Plating System for Craniomaxillofacial Surgery (K980983). The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K972463). 23 The Bioplate® Rigid Fixation Bone Plating System for Cranio…
Biomedics1997—
*K953273Bioplate Rigid Fixation Bone Plating System
Summary page 2
…Surgery (K972463). 23 The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K953273). The Bioplate® Titanium Fixation System (K943071). The Wurzberg Titanium Mini Bone Plates and Bone Screws…
Biomedics1995—
*K943071The Titanium Fixation System
Summary page 2
…The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K953273). The Bioplate® Titanium Fixation System (K943071). The Wurzberg Titanium Mini Bone Plates and Bone Screws (K854886) and the Maxillofacial Titanium Micro Set (K8548…
Biomedics1995—
*K854886Wuerzburg Titanium Mini Bone Plates & Bone Screws
Summary page 2
…Craniomaxillofacial Surgery (K953273). The Bioplate® Titanium Fixation System (K943071). The Wurzberg Titanium Mini Bone Plates and Bone Screws (K854886) and the Maxillofacial Titanium Micro Set (K854886). The Synthes Maxillofacial Titanium Micro Set (K912932). Descriptio…
Walter Lorenz Surgical, Inc.19861
*K912932Synthes Maxillofacial Titanium Micro Set
Summary page 2
…berg Titanium Mini Bone Plates and Bone Screws (K854886) and the Maxillofacial Titanium Micro Set (K854886). The Synthes Maxillofacial Titanium Micro Set (K912932). Description of the Device: The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery include a variet…
Synthes (Usa)1991—

Also cleared against K021684: 3 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082

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 20 years and passes through 2 companies; a new generation was cleared every 16.4 years on median.
  • 2 of the 18 ancestors have a recall of any class.
  • Of its descendants, K073006 (Takiron Co., Ltd., 2008) has gone furthest, with 2 descendants of its own.
  • 3 other devices also cite its predicate K021684.

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 modified plate designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery are intended for use in the reconstruction of the cranium (skull) following surgical decompression procedures of the posterior fossa or transcervical skull-based approach, with or without duraplasty including but not limited to procedures to treat Chiari I Malformation. The plate designs are also intended for use in non-load bearing fixation, including but not limited to cranial bone fixation. Each device is intended for single use only, and only in conjunction with other titanium and titanium alloy implants.

Indications for use as stated in the FDA summary.

Also cleared against K021684

3 other devices cite the same predicate.

  • K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation SystemCeremed, Inc. · 2005
  • K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2003
  • K023810Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, 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
  • K051845The Bioplate Resorbable Endobrow Fixation SystemBioplate, Inc. · 20051 recall
  • K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2003

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/K062819 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062819: Bioplate Rigid 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/K062819

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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