510(k) Report

510(k) · Cleared

Recalled · 2010

Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium Fixation System

K082757510(k) SpecialCleared Oct 1, 200812-day reviewClass II21 CFR 872.4760Recalls 1

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 Oct 1, 2008 as substantially equivalent to K022033 (Bioplate, Inc., 2002) and 11 other predicates after a 12-day review. Its family tree reaches back 2 generations to 1991. It has been recalled once.

Decided
Oct 1, 2008
Review
12 days
Class
Class II
Product code
JEY
Recalls
1
Predicates
13

Its longest line of descent runs back 2 generations to K910038 (1991). 13 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 2 other ancestors1995: 1 other ancestor1994: 3 other ancestors1993: 1 other ancestor1992: 2 other ancestors1991: 1 other ancestor1998: 1 other ancestorK910038 · Lorenz Ultra-Micro Titanium Osteosynthesis System · Walter Lorenz Surgical, Inc. · 1991K022033 · Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation System · Bioplate, Inc. · 200219901995200020052010
Other ancestors, by generation 1 generation back: 10 other ancestors2 generations back: 1 other ancestor K022033 · Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation System · Bioplate, Inc. · 2002K910038 · Lorenz Ultra-Micro Titanium Osteosynthesis System · Walter Lorenz Surgical, Inc. · 19910
  1. Root · 2 generations backK910038 Lorenz Ultra-Micro Titanium Osteosynthesis SystemWalter Lorenz Surgical, Inc. · 1991
  2. 1 generation backK022033 Sterile Plate & Screw Kit Configurations for Use with the Bioplate…Bioplate, Inc. · 2002
  3. This deviceK082757 Modified Sterile Plate & Screw Kit Configurations for Use with…Bioplate, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K910038Lorenz Ultra-Micro Titanium Osteosynthesis SystemWalter Lorenz Surgical, Inc.1991—
−1K022033Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium…Bioplate, Inc.2002—
0 (this device)K082757Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate…Bioplate, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199220
199310
199430
199510
199720
199810
FIG. 1 — Lineage of K082757, 1991–2008Source: 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? (13)

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
*K022033Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation…
Summary page 1
…Y Predicate Devices: Sterile Plate & Screw Configurations for use with the Bioplate® Titanium Fixation System (K022033) Walter Lorenz instruments, Inc. Lorenz 1.5mm Neuro Pack/Lorenz 2.OFT plates ( Sterile Version)…
Bioplate, Inc.2002—
*K972322Lorenz 1.5 MM Neuro Pack/Lorenz 2.0 FT Plates
Summary page 1
…(K022033) Walter Lorenz instruments, Inc. Lorenz 1.5mm Neuro Pack/Lorenz 2.OFT plates ( Sterile Version) (K972322) Synthes (USA) Maxillofacial Titanium Micro Set (K912932)…
Walter Lorenz Surgical, Inc.19971
*K912932Synthes Maxillofacial Titanium Micro Set
Summary page 1
…ro Pack/Lorenz 2.OFT plates ( Sterile Version) (K972322) Synthes (USA) Maxillofacial Titanium Micro Set (K912932) PG 24 TiMesh…
Synthes (Usa)1991—
*K923419Tismesh System
Summary page 2
…PG 24 TiMesh Inc., Softplates and Screws. (K923419, K923802, K973145) Techmedica, Inc., Anspach Fixation System (K921801) Walter Lorenz Surgical Instr…
Ti-Mesh, Inc.1993—
*K923802Timesh Titanium Mini-Softplate/Screw
Summary page 2
…PG 24 TiMesh Inc., Softplates and Screws. (K923419, K923802, K973145) Techmedica, Inc., Anspach Fixation System (K921801) Walter Lorenz Surgical Instruments, I…
Ti-Mesh, Inc.1992—
*K973145Timesh Titanium Mini-Softplate and Micro-Soft Plate/Screw System
Summary page 2
…PG 24 TiMesh Inc., Softplates and Screws. (K923419, K923802, K973145) Techmedica, Inc., Anspach Fixation System (K921801) Walter Lorenz Surgical Instruments, Inc.,…
Sofamor Danek USA,Inc.1997—
*K921801Modification Techmedica MP (Miniplating) System
Summary page 2
…24 TiMesh Inc., Softplates and Screws. (K923419, K923802, K973145) Techmedica, Inc., Anspach Fixation System (K921801) Walter Lorenz Surgical Instruments, Inc., Ultra-Micro Titanium Cranial Osteosynthesis System, (K910038)…
Techmedica, Inc.1992—
*K910038Lorenz Ultra-Micro Titanium Osteosynthesis System
Summary page 2
…nc., Anspach Fixation System (K921801) Walter Lorenz Surgical Instruments, Inc., Ultra-Micro Titanium Cranial Osteosynthesis System, (K910038) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.0mm) (K944561) KLS-Martin L.P. KL…
Walter Lorenz Surgical, Inc.1991—
*K944561Micro Osteosynthesis System (1.0)
Summary page 2
…, Inc., Ultra-Micro Titanium Cranial Osteosynthesis System, (K910038) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.0mm) (K944561) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.5mm) (K944545) KLS-Martin L.P. KL…
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
…Martin L.P. KLS-Martin Micro Osteosynthesis System (1.5mm) (K944545) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (2.0mm)) (K943347) Sofamor Danek Timesh System (K947017) HFwmedica, Inc., Luhr Titanium Pan Fixation System…
Patton, Boggs & Blow1994—
Kept off the family treeK947017Timesh System
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 2
….5mm) (K944545) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (2.0mm)) (K943347) Sofamor Danek Timesh System (K947017) HFwmedica, Inc., Luhr Titanium Pan Fixation System (K945139) Description of the Device: The Bioplate® T…
*K945139Luhr Titanium Pan Fixation System
Summary page 2
…is System (2.0mm)) (K943347) Sofamor Danek Timesh System (K947017) HFwmedica, Inc., Luhr Titanium Pan Fixation System (K945139) Description of the Device: The Bioplate® Titanium Fixation System includes a variety of plate configurations for different an…
Howmedica Corp.1995—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 31, 2010Not classifiedZ-0143-2012Process designThere is potential defect in seal of the sterile barrier containing the device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 11.4 years on median.
  • 2 of the 13 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. 2008, this device’s year, is highlighted.

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 sterile plate and screw kit configurations for use with the Bioplate ® Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant

Indications for use as stated in the FDA summary.

More from Bioplate, Inc.

23 FDA decisions under this applicant name. See the company

  • 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
  • K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2003

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/K082757 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082757: Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium 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/K082757

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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