510(k) Report

510(k) · Cleared

Cleared

Modification to Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery

K023665510(k) SpecialCleared Nov 22, 200222-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 Nov 22, 2002 as substantially equivalent to K943071 (Biomedics, 1995) and 11 other predicates after a 22-day review. Its family tree reaches back 1 generation to 1991.

Decided
Nov 22, 2002
Review
22 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
12

Its longest line of descent runs back 1 generation to K910038 (1991). 12 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestor1995: 2 other ancestors1994: 3 other ancestors1993: 1 other ancestor1992: 2 other ancestorsK910038 · Lorenz Ultra-Micro Titanium Osteosynthesis System · Walter Lorenz Surgical, Inc. · 199119901992199419961998200020022004
Other ancestors, by generation 1 generation back: 11 other ancestors K910038 · Lorenz Ultra-Micro Titanium Osteosynthesis System · Walter Lorenz Surgical, Inc. · 19910
  1. Root · 1 generation backK910038 Lorenz Ultra-Micro Titanium Osteosynthesis SystemWalter Lorenz Surgical, Inc. · 1991
  2. This deviceK023665 Modification to Bioplate Rigid Bone Plating System for…Bioplate, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K910038Lorenz Ultra-Micro Titanium Osteosynthesis SystemWalter Lorenz Surgical, Inc.1991—
0 (this device)K023665Modification to Bioplate Rigid Bone Plating System for Craniomaxillofacial…Bioplate, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199310
199430
199520
199710
199810
199910
FIG. 1 — Lineage of K023665, 1991–2002Source: 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 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? (12)

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
*K943071The Titanium Fixation System
Summary page 1
…Bone Plate (21 CFR 872.4760) Predicate Devices Bioplate, Inc. BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K943071 Bioplate, Inc. BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K992330…
Biomedics1995—
*K992330The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Summary page 1
…for Craniomaxillofacial Surgery K943071 Bioplate, Inc. BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K992330 TiMesh Inc. Softplates and screws K923419, K923802, K973145 (4) Techmedica, Inc. Anspach F…
Biomedics1999—
*K923419Tismesh System
Summary page 1
…ioplate, Inc. BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K992330 TiMesh Inc. Softplates and screws K923419, K923802, K973145 (4) Techmedica, Inc. Anspach Fixation System K921801 (5) Walter Lorenz Surgical Instru…
Ti-Mesh, Inc.1993—
*K923802Timesh Titanium Mini-Softplate/Screw
Summary page 1
…Inc. BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K992330 TiMesh Inc. Softplates and screws K923419, K923802, K973145 (4) Techmedica, Inc. Anspach Fixation System K921801 (5) Walter Lorenz Surgical Instruments, In…
Ti-Mesh, Inc.1992—
*K973145Timesh Titanium Mini-Softplate and Micro-Soft Plate/Screw System
Summary page 1
…BioplateB Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K992330 TiMesh Inc. Softplates and screws K923419, K923802, K973145 (4) Techmedica, Inc. Anspach Fixation System K921801 (5) Walter Lorenz Surgical Instruments, Inc. Ul…
Sofamor Danek USA,Inc.1997—
*K921801Modification Techmedica MP (Miniplating) System
Summary page 2
…Surgery K992330 TiMesh Inc. Softplates and screws K923419, K923802, K973145 (4) Techmedica, Inc. Anspach Fixation System K921801 (5) Walter Lorenz Surgical Instruments, Inc. Ultra-micro Titanium Cranial Osteosynthesis System K910038 (6) KLS-Martin…
Techmedica, Inc.1992—
*K910038Lorenz Ultra-Micro Titanium Osteosynthesis System
Summary page 2
…=== (4) Techmedica, Inc. Anspach Fixation System K921801 (5) Walter Lorenz Surgical Instruments, Inc. Ultra-micro Titanium Cranial Osteosynthesis System K910038 (6) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.Omm) L944561 (7) KLS-Martin L.P. KLS-Martin Micro…
Walter Lorenz Surgical, Inc.1991—
*K944561Micro Osteosynthesis System (1.0)
Summary page 2
…urgical Instruments, Inc. Ultra-micro Titanium Cranial Osteosynthesis System K910038 (6) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.Omm) L944561 (7) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.5mm) K944545 (8) KLS-Martin L.P. KLS-Martin…
KLS-Martin L.P.1994—
*K944565KLS-Martin Micro Osteosythesis System (1.5MM)
Our reading of the summary gave K944545, FDA’s number for Body Fluids Barrier Kit (Ani Safety, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “KLS-Martin Micro Osteosynthesis System (1.5mm)”.
KLS-Martin L.P.1994—
*K943347KLS Mini Osteosynthesis System
Summary page 2
…561 (7) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.5mm) K944545 (8) KLS-Martin L.P. KLS-Martin Osteosynthesis System (2.Omm) K943347 (9) Sofamor Danek Timesh System K974017 (10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139 Desc…
Patton, Boggs & Blow1994—
*K974017Timesh System
Summary page 2
…Osteosynthesis System (1.5mm) K944545 (8) KLS-Martin L.P. KLS-Martin Osteosynthesis System (2.Omm) K943347 (9) Sofamor Danek Timesh System K974017 (10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139 Description of the device Modified plate designs for…
Sofamor Danek USA,Inc.19981
*K945139Luhr Titanium Pan Fixation System
Summary page 2
…KLS-Martin Osteosynthesis System (2.Omm) K943347 (9) Sofamor Danek Timesh System K974017 (10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139 Description of the device Modified plate designs for use with the BioplateB Rigid Fixation Bone Plating System for Craniomaxil…
Howmedica Corp.1995—

Also cleared against K943071: 4 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?

  • 1 of the 12 ancestors has a recall of any class.
  • 4 other devices also cite its predicate K943071.

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 modified plate designs for use with the Bioplate 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-load bearing fixation, including cranial bone 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 K943071

4 other devices cite the same predicate.

  • K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2006
  • 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
  • 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/K023665 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023665: Modification to 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 6, 2026. https://510kreport.com/device/K023665

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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