510(k) Report

510(k) · Cleared

Cleared

Imtec/Titanium Mesh

K970841510(k) TraditionalCleared Apr 30, 199754-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

Imtec Corp. · JEY Plate, Bone

Cleared on Apr 30, 1997 as substantially equivalent to K862532 (Walter Lorenz Surgical, Inc., 1986) and 3 other predicates after a 54-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.

Decided
Apr 30, 1997
Review
54 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K862482 (1986). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1993: 1 other ancestor1986: 1 other ancestor2010: 1 descendant cleared2011: 1 descendant clearedK862482 · Steinhauser Titanium Mini Bone Plates & Screws · Walter Lorenz Surgical, Inc. · 19861990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K862482 · Steinhauser Titanium Mini Bone Plates & Screws · Walter Lorenz Surgical, Inc. · 19860
  1. Root · 1 generation backK862482 Steinhauser Titanium Mini Bone Plates & ScrewsWalter Lorenz Surgical, Inc. · 1986
  2. This deviceK970841 Imtec/Titanium MeshImtec Corp. · 1997
  3. Descendant · cites it directly · 1 of its ownK091120 Medpor Contain ImplantPorex Surgical, Inc. · 2010
  4. Descendant · 2 generations on · 0 of its ownK102184 Medpor Contain Can ImplantPorex Surgical, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K091120Medpor Contain ImplantPorex Surgical, Inc. · 2010 · cites it directly1descendant
  • K102184Medpor Contain Can ImplantPorex Surgical, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K862482Steinhauser Titanium Mini Bone Plates & ScrewsWalter Lorenz Surgical, Inc.1986—
0 (this device)K970841Imtec/Titanium MeshImtec Corp.1997—
+1K091120Medpor Contain ImplantPorex Surgical, Inc.2010—
+2K102184Medpor Contain Can ImplantPorex Surgical, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199310
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
FIG. 1 — Lineage of K970841, 1986–2011Source: 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? (4)

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
*K862532Dumbach Titanium Mesh Implant System
Summary page 1
…um foil (CFR 878.3300) Common/ Usual Name: Titanium Mesh. Proprietary Name: IMTEC/ TitaniumMesh PREDICATE DEVICE: Leibinger, Micro-Titanium Augmentation Mesh ( M-TAM™) K 862532 Osteomed, , Osteomed MSS (Ti Ridge Augmentation Material) K963394 Wailter Lorenz Surgical, Inc., Ti Mini Bone Plate and Screws, K…
Walter Lorenz Surgical, Inc.1986—
*K963394Osteomed Tram
Summary page 1
…ry Name: IMTEC/ TitaniumMesh PREDICATE DEVICE: Leibinger, Micro-Titanium Augmentation Mesh ( M-TAM™) K 862532 Osteomed, , Osteomed MSS (Ti Ridge Augmentation Material) K963394 Wailter Lorenz Surgical, Inc., Ti Mini Bone Plate and Screws, K862482 TiMesh Inc., Reconstructive Surgery System,K923491 DEVICE…
Osteomed Corp.1996—
*K862482Steinhauser Titanium Mini Bone Plates & Screws
Summary page 1
…nium Augmentation Mesh ( M-TAM™) K 862532 Osteomed, , Osteomed MSS (Ti Ridge Augmentation Material) K963394 Wailter Lorenz Surgical, Inc., Ti Mini Bone Plate and Screws, K862482 TiMesh Inc., Reconstructive Surgery System,K923491 DEVICE DESCRIPTION: The IMTEC/TitaniumMesh consists of a laser cut segment of…
Walter Lorenz Surgical, Inc.1986—
*K923419Tismesh System
Our OCR of the scanned summary read K923491, FDA’s number for Bte Hearing Aid Personic 425 (Oticon Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “TiMesh Inc., Reconstructive Surgery System”.
Ti-Mesh, Inc.1993—

Also cleared against K862532: 2 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K091120Medpor Contain ImplantPorex Surgical, Inc.20101

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K091120 (Porex Surgical, Inc., 2010) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K862532.

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—

Also cleared against K862532

2 other devices cite the same predicate.

  • K022185Universal CMF SystemStryker Instruments · 2002
  • K983360Macropore Protective SheetPacific Materials and Interfaces · 1999

More from Imtec Corp.

28 FDA decisions under this applicant name. See the company

  • K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 20081 recall
  • K081347Iluma VisionImtec Corp. · 20081 recall
  • K072660Endure Implant, Model 5108, 5111, 5113, 5114Imtec Corp. · 2007
  • K053046Iluma Orthocat/DentalcatImtec Corp. · 2005
  • K043226Endure Implant, Models 3508, 4308, 3520, 4320Imtec Corp. · 2005

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/K970841 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970841: Imtec/Titanium Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970841

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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