510(k) Report

510(k) · Cleared

Cleared

Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation System

K051293510(k) TraditionalCleared Jun 14, 200527-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

Ceremed, Inc. · JEY Plate, Bone

Cleared on Jun 14, 2005 as substantially equivalent to K023810 (Bioplate, Inc., 2002) and 8 other predicates after a 27-day review. Its family tree reaches back 4 generations to 1998.

Decided
Jun 14, 2005
Review
27 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
10

Its longest line of descent runs back 4 generations to K971252 (1998). 31 ancestors in all, the oldest K854886 (1986). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 2 other ancestors2001: 2 other ancestors1999: 3 other ancestors1997: 2 other ancestors1995: 3 other ancestors2000: 2 other ancestors1998: 4 other ancestors1994: 3 other ancestors1993: 1 other ancestor1992: 2 other ancestors1991: 2 other ancestors1986: 1 other ancestorK971252 · 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. · 200119851990199520002005
Other ancestors, by generation 1 generation back: 8 other ancestors2 generations back: 19 other ancestors 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 deviceK051293 Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed…Ceremed, Inc. · 2005
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)K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation…Ceremed, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199120
199220
199310
199430
199530
199720
199840
199930
200020
200120
200220
FIG. 1 — Lineage of K051293, 1998–2005Source: 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? (10)

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
*K023810Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…
Summary page 1
…anioplasty preformed, non-alterable Predicate Devices 1. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K023810 2. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K021684 3. Bioplate, Inc. Zip Craniotomy Fixation Sy…
Bioplate, Inc.2002—
*K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Summary page 1
…redicate Devices 1. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K023810 2. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K021684 3. Bioplate, Inc. Zip Craniotomy Fixation System K020880 4. Bioplate, Inc. Bioclip Craniotomy Fixation System K0130…
Bioplate, Inc.2002—
Kept off the family treeK020880FDA’s K020880 is Marknew Products Acupuncture Needles
Our reading of the summary gave K020880, FDA’s number for Marknew Products Acupuncture Needles (Marknew Products). Its FDA name has none of the distinctive words the summary uses for the device it names, “Zip Craniotomy Fixation System”. Kept off the family tree.
Summary page 1
…maxillofacial Surgery K023810 2. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K021684 3. Bioplate, Inc. Zip Craniotomy Fixation System K020880 4. Bioplate, Inc. Bioclip Craniotomy Fixation System K013055 5. Bioplate, Inc. Zip Craniotomy Fixation System K0130…
Marknew Products2002—
*K013055The Bioplate Bioclip Craniotomy Fixation System
Summary page 1
…em for Craniomaxillofacial Surgery K021684 3. Bioplate, Inc. Zip Craniotomy Fixation System K020880 4. Bioplate, Inc. Bioclip Craniotomy Fixation System K013055 5. Bioplate, Inc. Zip Craniotomy Fixation System K013050 6. Bioplate, Inc. Bioclip Craniotomy Fixation System K0113…
Bioplate, Inc.2001—
*K013050The Bioplate Zip Craniotomy Fixation System
Summary page 1
…Zip Craniotomy Fixation System K020880 4. Bioplate, Inc. Bioclip Craniotomy Fixation System K013055 5. Bioplate, Inc. Zip Craniotomy Fixation System K013050 6. Bioplate, Inc. Bioclip Craniotomy Fixation System K011380 7. Bioplate, Inc.…
Bioplate, Inc.2001—
*K011380Modification to the Bioplate Bioclip Craniotomy Fixation System
Summary page 1
…Bioclip Craniotomy Fixation System K013055 5. Bioplate, Inc. Zip Craniotomy Fixation System K013050 6. Bioplate, Inc. Bioclip Craniotomy Fixation System K011380 7. Bioplate, Inc. Ceremed, Inc. Page 7 - 2…
Bioplate, Inc.2001—
*K992330The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Summary page 2
…arket Notification - CranionT Cranial Fixation System M Fixation System for Craniomaxillofacial Surgery K992330 8. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K972463 9. Bioplate, Inc. Fixation System for Cranio…
Biomedics1999—
*K972463The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Summary page 2
…M Fixation System for Craniomaxillofacial Surgery K992330 8. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K972463 9. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K953273 10. Bioplate, Inc. Fixation System for Cran…
Biomedics1997—
*K953273Bioplate Rigid Fixation Bone Plating System
Summary page 2
…ery K992330 8. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K972463 9. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K953273 10. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K943071 Description of the device: The CranionTM C…
Biomedics1995—
*K943071The Titanium Fixation System
Summary page 2
…y K972463 9. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K953273 10. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K943071 Description of the device: The CranionTM Cranial Fixation System includes a variety of plate configurations for different anat…
Biomedics1995—

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 7 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
  • 3 of the 31 ancestors have a recall of any class.

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 CranionTM Cranial Fixation System intended for reconstruction of the craniomaxillofacial skeleton and for reattachment of cranial bone flaps after craniotomy procedures. The system is used to align and stabilized bony tissue while normal healing occurs. Each implantable component is intended for single use only and may be combined only with other titanium and titanium alloy implants.

Indications for use as stated in the FDA summary.

More from Ceremed, Inc.

20 FDA decisions under this applicant name. See the company

  • K161446Biopor Porous Polyethylene ImplantsCeremed, Inc. · 2016
  • K160988Biopor, AOC Porous Polyethylene, CereporCeremed, Inc. · 2016
  • K141880Biopor Aoc Porous Polyethylene, CereporCeremed, Inc. · 2015
  • K132198Adaptain, Adaptain Fastwrap, Envelock, BiowaiCeremed, Inc. · 2013
  • K122561Adaptain Fastwrap, Envelock, GraftainCeremed, Inc. · 2012

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/K051293 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051293: Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed 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/K051293

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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