510(k) Report

510(k) · Cleared

Cleared

The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery

K031028510(k) SpecialCleared Apr 28, 200327-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 Apr 28, 2003 as substantially equivalent to K022890 (Bioplate, Inc., 2002) and 3 other predicates after a 27-day review. Its family tree reaches back 6 generations to 1976.

Decided
Apr 28, 2003
Review
27 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K761228 (1976). 31 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor1997: 4 other ancestors1995: 2 other ancestors1998: 2 other ancestors1994: 4 other ancestors1993: 1 other ancestor1992: 2 other ancestors1991: 3 other ancestors1986: 2 other ancestors1996: 3 other ancestors1988: 1 other ancestorK761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997K970912 · Leibinger Self-Drilling Screw · Howmedica Leibinger, Inc. · 1997K974785 · Auto-Drive Bone Screw · Osteomed Corp. · 1998K013954 · Lorenz Self Drilling Screws · Walter Lorenz Surgical, Inc. · 2002K022890 · Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery · Bioplate, Inc. · 20021975198019851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 14 other ancestors3 generations back: 1 other ancestor4 generations back: 2 other ancestors5 generations back: 5 other ancestors K022890 · Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery · Bioplate, Inc. · 2002K013954 · Lorenz Self Drilling Screws · Walter Lorenz Surgical, Inc. · 2002K974785 · Auto-Drive Bone Screw · Osteomed Corp. · 1998K970912 · Leibinger Self-Drilling Screw · Howmedica Leibinger, Inc. · 1997K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997K761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976−50
  1. Root · 6 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 5 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
  3. 4 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
  4. 3 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
  5. 2 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
  6. 1 generation backK022890 Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone…Bioplate, Inc. · 2002
  7. This deviceK031028 The Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K761228Luhr Mandibular Compression-Screw SystemHowmedica Corp.1976—
−5K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997—
−4K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997—
−3K974785Auto-Drive Bone ScrewOsteomed Corp.1998—
−2K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002—
−1K022890Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating…Bioplate, Inc.2002—
0 (this device)K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198620
198810
199130
199220
199310
199440
199520
199630
199740
199820
200210
FIG. 1 — Lineage of K031028, 1976–2003Source: 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? (4)

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
*K022890Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for…
Summary page 2
…axillofacial surgery have the same indications for use as the BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K943071 - K972463 - KO21684 - K022890) predicate devices. All of the technical characteristics are substantially equivalent to the corresponding characteristics of the…
Bioplate, Inc.2002—
*K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.2002—
*K972463The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Summary page 1
…Craniomaxillofacial Surgery KO21684 Bioplate, Inc. Bioplatm Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K972463 (4) Bioplate, Inc. Bioplatm Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K94307…
Biomedics1997—
*K943071The Titanium Fixation System
Summary page 2
…Craniomaxillofacial Surgery K972463 (4) Bioplate, Inc. Bioplatm Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K943071 Description of the device The modified screw designs for use in conjunction with the BioplateB Rigid Fixation Bone Plating Syst…
Biomedics1995—

Also cleared against K022890: 2 other devices →

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 27 years and passes through 5 companies; a new generation was cleared every 8 months on median.
  • 2 of the 31 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K022890.

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 BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation, brow fixation and orbital 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 K022890

2 other devices cite the same predicate.

  • K141764Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
  • K030806Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2003

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/K031028 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031028: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031028

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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