510(k) Report

510(k) · Cleared

Cleared

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

K022033510(k) SpecialCleared Jul 19, 200228-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 Jul 19, 2002 as substantially equivalent to K972322 (Walter Lorenz Surgical, Inc., 1997) and 11 other predicates after a 28-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.

Decided
Jul 19, 2002
Review
28 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. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1997: 2 other ancestors1995: 1 other ancestor1994: 3 other ancestors1993: 1 other ancestor1992: 2 other ancestors1991: 1 other ancestor2008: 1 descendant clearedK910038 · Lorenz Ultra-Micro Titanium Osteosynthesis System · Walter Lorenz Surgical, Inc. · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors 1 generation forward: 1 descendant 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 deviceK022033 Sterile Plate & Screw Kit Configurations for Use with the Bioplate…Bioplate, Inc. · 2002
  3. Descendant · cites it directly · 0 of its ownK082757 Modified Sterile Plate & Screw Kit Configurations for Use with…Bioplate, Inc. · 2008 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K082757Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium…Bioplate, Inc. · 2008 · cites it directly0descendants
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)K022033Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium…Bioplate, Inc.2002—
+1K082757Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate…Bioplate, Inc.20081

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199220
199310
199430
199510
199720
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K022033, 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? (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
*K972322Lorenz 1.5 MM Neuro Pack/Lorenz 2.0 FT Plates
Summary page 1
…te (21 CFR 872.4760) Predicate Devices Walter Lorenz Surgical Instruments, lnc. Lorenz 1.5mm Neuro PacWLorenz 2.0FT Plates (Sterile Version) K972322 Synthes (USA) Maxillofacial Titanium Micro Set K912932 TiMesh Inc. Softplates and screw…
Walter Lorenz Surgical, Inc.19971
*K912932Synthes Maxillofacial Titanium Micro Set
Summary page 1
…uments, lnc. Lorenz 1.5mm Neuro PacWLorenz 2.0FT Plates (Sterile Version) K972322 Synthes (USA) Maxillofacial Titanium Micro Set K912932 TiMesh Inc. Softplates and screws K923419, K923802, K973145 Techmedica, Inc. Anspach Fi…
Synthes (Usa)1991—
*K923419Tismesh System
Summary page 1
…erile Version) K972322 Synthes (USA) Maxillofacial Titanium Micro Set K912932 TiMesh Inc. Softplates and screws K923419, K923802, K973145 Techmedica, Inc. Anspach Fixation System K921801 (5) Walter Lorenz Sur…
Ti-Mesh, Inc.1993—
*K923802Timesh Titanium Mini-Softplate/Screw
Summary page 1
…sion) K972322 Synthes (USA) Maxillofacial Titanium Micro Set K912932 TiMesh Inc. Softplates and screws K923419, K923802, K973145 Techmedica, Inc. Anspach Fixation System K921801 (5) Walter Lorenz Surgical Ins…
Ti-Mesh, Inc.1992—
*K973145Timesh Titanium Mini-Softplate and Micro-Soft Plate/Screw System
Summary page 1
…K972322 Synthes (USA) Maxillofacial Titanium Micro Set K912932 TiMesh Inc. Softplates and screws K923419, K923802, K973145 Techmedica, Inc. Anspach Fixation System K921801 (5) Walter Lorenz Surgical Instruments,…
Sofamor Danek USA,Inc.1997—
*K921801Modification Techmedica MP (Miniplating) System
Summary page 1
…et K912932 TiMesh Inc. Softplates and screws K923419, K923802, K973145 Techmedica, Inc. Anspach Fixation System K921801 (5) Walter Lorenz Surgical Instruments, Inc. Ultra-micro Titanium Cranial Osteosynthesis System K910038…
Techmedica, Inc.1992—
*K910038Lorenz Ultra-Micro Titanium Osteosynthesis System
Summary page 2
…. 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 Mic…
Walter Lorenz Surgical, Inc.1991—
*K944561Micro Osteosynthesis System (1.0)
Summary page 2
…l 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 Oseosynth…
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
…m) L944561 (7) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.5mm) K944545 (8) KLS-Martin L.P. KLS-Martin Oseosynthesis System (2.0mm) K943347 (9) Sofamor Danek Timesh System K974017 (10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139 Descr…
Patton, Boggs & Blow1994—
*K974017Timesh System
Summary page 2
…tin Micro Osteosynthesis System (1.5mm) K944545 (8) KLS-Martin L.P. KLS-Martin Oseosynthesis System (2.0mm) K943347 (9) Sofamor Danek Timesh System K974017 (10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139 Description of the device The sterile plate and screw…
Sofamor Danek USA,Inc.19981
*K945139Luhr Titanium Pan Fixation System
Summary page 2
…KLS-Martin Oseosynthesis System (2.0mm) K943347 (9) Sofamor Danek Timesh System K974017 (10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139 Description of the device The sterile plate and screw kit configurations for use with the BioplateB Titanium Fixation System in…
Howmedica Corp.1995—

Also cleared against K972322: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K082757Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium…Bioplate, Inc.20080

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?

  • 2 of the 12 ancestors have a recall of any class.
  • Of its descendants, K082757 (Bioplate, Inc., 2008) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K972322.

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 sterile plate and screw kit configurations for use with the BioplateB Titanium Fixation System are intended for use in non-load bearing fixation, including cranial bone fixation and brow fixation, and the treatment of fractures and reconstructive procedures of the craniomaxillofacialskeleton and. Each device is intended for single use only, and only in conjunctionwith other titanium and titanium alloy implants.

Indications for use as stated in the FDA summary.

Also cleared against K972322

2 other devices cite the same predicate.

  • K102641Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A · 2010
  • K082757Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium Fixation SystemBioplate, Inc. · 20081 recall

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/K022033 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022033: Sterile Plate & Screw Kit Configurations for Use with the 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/K022033

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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