510(k) Report

510(k) · Cleared

Recalled · 2006

Timesh System

K974017510(k) TraditionalCleared Jan 16, 199886-day reviewClass II21 CFR 888.3030Recalls 1

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. · HRS Plate, Fixation, Bone

Cleared on Jan 16, 1998 after an 86-day review. The FDA summary names no predicate by number. 53 later devices descend from it. It has been recalled once.

Decided
Jan 16, 1998
Review
86 days
Class
Class II
Product code
HRS
Recalls
1
Predicates
0

53 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared1999: 1 descendant cleared2002: 6 descendants cleared2006: 3 descendants cleared2005: 5 descendants cleared2003: 1 descendant cleared2008: 4 descendants cleared2010: 2 descendants cleared2004: 3 descendants cleared2001: 1 descendant cleared2007: 3 descendants cleared2013: 2 descendants cleared2011: 1 descendant cleared2012: 2 descendants cleared2018: 2 descendants cleared2016: 1 descendant cleared2024: 2 descendants cleared2020: 3 descendants cleared2021: 2 descendants cleared2025: 1 descendant cleared2023: 2 descendants cleared2022: 2 descendants cleared2019: 2 descendants cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK974017 Timesh SystemSofamor Danek USA,Inc. · 1998
  2. Descendant · cites it directly · 35 of its ownK994158 Macrosorbos Protective SheetMacropore Biosurgery, Inc. · 2000
  3. Descendant · 2 generations on · 21 of its ownK031961 Inion Otps Biodegradable Mesh Plating SystemInion, Ltd. · 2004
  4. Descendant · 3 generations on · 17 of its ownK123672 Inion Freedomscrew (Alternative Marketing Name: Inion Otps…Inion OY · 2013
  5. Descendant · 4 generations on · 8 of its ownK160304 OsteoBullet Compression ScrewPhalanx Innovations · 2016
  6. Descendant · 2 generations on · 7 of its ownK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

1999: 12000: 12001: 12002: 62003: 12004: 32005: 52006: 32007: 32008: 42010: 22011: 12012: 22013: 22016: 12018: 22019: 22020: 32021: 22022: 22023: 22024: 22025: 12026: 1
1999high 6 (2002) · low 0 (2009)2026

Most influential descendants

Showing 5 of 53 · See all
  • K994158Macrosorbos Protective SheetMacropore Biosurgery, Inc. · 2000 · cites it directly35descendants
  • K031961Inion Otps Biodegradable Mesh Plating SystemInion, Ltd. · 2004 · 2 generations on21descendants
  • K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY · 2013 · 3 generations on17descendants
  • K160304OsteoBullet Compression ScrewPhalanx Innovations · 2016 · 4 generations on8descendants
  • K022139Hip Tool ImplantOrthopedic Sciences, Inc. · 2002 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K974017Timesh SystemSofamor Danek USA,Inc.1998—
+1K994158Macrosorbos Protective SheetMacropore Biosurgery, Inc.2000—
+2K031961Inion Otps Biodegradable Mesh Plating SystemInion, Ltd.2004—
+3K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY2013—
+4K160304OsteoBullet Compression ScrewPhalanx Innovations2016—
+2K022139Hip Tool ImplantOrthopedic Sciences, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200110
200260
200310
200430
200550
200630
200730
200840
201020
201110
201220
201320
201610
201820
201920
202030
202120
202220
202320
202420
202510
202610
FIG. 1 — Lineage of K974017, 1998–2026Source: 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 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? (53)

See all 53

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

NumberDeviceApplicantDecidedDescendants
K994158Macrosorbos Protective SheetMacropore Biosurgery, Inc.200035
K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20027
K062348Timesh Self Drilling ScrewMedtronic Neurosurgery20063
K022033Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation…Bioplate, Inc.20021
K023665Modification to Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20020
K020853Nuvasive MeshNuvasive, Inc.20020
K992106Modus System Self-Drilling ScrewsMedartis AG19990

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 8, 2006Not classifiedZ-0849-06OtherMedtronic Neurosurgery has initiated this action because it was determined that two lots of the Modular Screwdriver Blade components may exhiibt burrs along the tips of the Screwdriver, which may prevent adequate engagement with the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K994158 (Macropore Biosurgery, Inc., 2000) has gone furthest, with 35 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The TIMESH System is intended for use in any oral-maxillo-cranio-facial surgical reconstructive procedure, either orthognathic or trauma, wherein rigid or semi-rigid internal fixation is utilized as a means of holding bone fragments together. Alternatively, the TIMESH System is also indicated for use in reinforcing weak bony tissues in orthopaedic surgical procedures such as pelvic reconstruction. acetabular reconstruction, and cement restriction. This product is not intended for spinal use.

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 HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K974017 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974017: Timesh System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974017

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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