510(k) · Cleared

Cleared

Timesh Self Drilling Screw

K062348510(k) SpecialCleared Sep 8, 200628-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Neurosurgery · HWC Screw, Fixation, Bone

Cleared on Sep 8, 2006 as substantially equivalent to K974017 (Sofamor Danek USA,Inc., 1998) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it.

Decided: Sep 8, 2006
Review: 28 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K923419 (1993). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK923419 Tismesh SystemTi-Mesh, Inc. · 1993
This deviceK062348 Timesh Self Drilling ScrewMedtronic Neurosurgery · 2006
Descendant · cites it directly · 2 of its ownK100779 Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2010
Descendant · 2 generations on · 1 of its ownK110259 Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2011
Descendant · 2 generations on · 0 of its ownK120271 Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2012

Most influential descendants

Showing 3 of 3 · See all

K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2010 · cites it directly2descendants
K110259Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on1descendant
K120271Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923419	Tismesh System	Ti-Mesh, Inc.	1993	—
0 (this device)	K062348	Timesh Self Drilling Screw	Medtronic Neurosurgery	2006	—
+1	K100779	Sustain Space Maintenance System	Medtronic Sofamor Danek USA, Inc.	2010	—
+2	K110259	Architex Space Maintenance System	Medtronic Sofamor Danek USA, Inc.	2011	—
+2	K120271	Artisan Space Maintenance System	Medtronic Sofamor Danek USA, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	1	0
2012	1	0

FIG. 1 — Lineage of K062348, 1993–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K974017	Timesh System Summary page 1 …on usual or Classification Name: Single/multiple component metallic bone fixation appliances and accessories (888.3030) Predicate Device Identification: TiMesh® System (K974017, K923419) Description: The device consists of a system of mesh, wire, screws, and plates of various sizes and shapes to be used…	Sofamor Danek USA,Inc.	1998	1
*	K923419	Tismesh System Summary page 1 …or Classification Name: Single/multiple component metallic bone fixation appliances and accessories (888.3030) Predicate Device Identification: TiMesh® System (K974017, K923419) Description: The device consists of a system of mesh, wire, screws, and plates of various sizes and shapes to be used for rigid…	Ti-Mesh, Inc.	1993	—

Also cleared against K974017: 6 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K100779	Sustain Space Maintenance System	Medtronic Sofamor Danek USA, Inc.	2010	2

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 2 ancestors has a recall of any class.
Of its descendants, K100779 (Medtronic Sofamor Danek USA, Inc., 2010) has gone furthest, with 2 descendants of its own.
6 other devices also cite its predicate K974017.

How does its category compare?

All HWC devices

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

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

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 fixatlon 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.

https://510kreport.com/device/K062348 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062348: Timesh Self Drilling Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062348

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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