510(k) Report

510(k) · Cleared

Cleared

Timesh Titanium Mini-Softplate and Micro-Soft Plate/Screw System

K973145510(k) TraditionalCleared Nov 19, 199789-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

Sofamor Danek USA,Inc. · JEY Plate, Bone

Cleared on Nov 19, 1997 after an 89-day review. The FDA summary names no predicate by number. 12 later devices descend from it.

Decided
Nov 19, 1997
Review
89 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
0

12 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2002: 5 descendants cleared2008: 2 descendants cleared2006: 1 descendant cleared2005: 1 descendant cleared2003: 1 descendant cleared2013: 1 descendant cleared2010: 1 descendant cleared1995200020052010201520202025
  1. This deviceK973145 Timesh Titanium Mini-Softplate and Micro-Soft Plate/Screw SystemSofamor Danek USA,Inc. · 1997
  2. Descendant · cites it directly · 7 of its ownK021684 The Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc. · 2002
  3. Descendant · 2 generations on · 3 of its ownK062819 Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2006
  4. Descendant · 3 generations on · 2 of its ownK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
  5. Descendant · 2 generations on · 1 of its ownK023810 Modification to Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc. · 2002
  6. Descendant · cites it directly · 1 of its ownK022033 Sterile Plate & Screw Kit Configurations for Use with the Bioplate…Bioplate, Inc. · 2002

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2002: 52003: 12005: 12006: 12008: 22010: 12013: 1
2002high 5 (2002) · low 0 (2004)2026

Most influential descendants

Showing 5 of 12 · See all
  • K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2002 · cites it directly7descendants
  • K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2006 · 2 generations on3descendants
  • K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008 · 3 generations on2descendants
  • K023810Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc. · 2002 · 2 generations on1descendant
  • K022033Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation…Bioplate, Inc. · 2002 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973145Timesh Titanium Mini-Softplate and Micro-Soft Plate/Screw SystemSofamor Danek USA,Inc.1997—
+1K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.2002—
+2K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.2006—
+3K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.2008—
+2K023810Modification to Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc.2002—
+1K022033Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium…Bioplate, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200250
200310
200510
200610
200820
201010
201310
FIG. 1 — Lineage of K973145, 1997–2013Source: 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?

The FDA summary names no predicate by number.

What descends from it? (12)

See all 12

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20027
K022033Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation…Bioplate, Inc.20021
K082757Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium…Bioplate, Inc.20080
K023665Modification to Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20020
K020853Nuvasive MeshNuvasive, Inc.20020

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?

  • Of its descendants, K021684 (Bioplate, Inc., 2002) has gone furthest, with 7 descendants of its own.

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 TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System is intended for use in any oral-maxilio-cranio-facial surgical procedure, either orthognathic or trauma, wherein rigid or semi-rigid internal fixation is utilized as a means of holding bone fragments together.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Sofamor Danek USA,Inc.

41 FDA decisions under this applicant name. See the company

  • K991031Colorado II Spinal SystemSofamor Danek USA,Inc. · 20001 recall
  • K984360Colorado II Spinal SystemSofamor Danek USA,Inc. · 2000
  • K992928CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
  • K991036Danek Plate and Screw SystemSofamor Danek USA,Inc. · 1999
  • K991198Dyna-Lok Plus Spinal SystemSofamor Danek USA,Inc. · 1999

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/K973145 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973145: Timesh Titanium Mini-Softplate and Micro-Soft Plate/Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973145

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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