510(k) Report

510(k) · Cleared

Cleared

Depuy Orthotech Restore Orthobiologic Soft Tissue Implant

K982330510(k) TraditionalCleared Sep 25, 199885-day reviewClass II21 CFR 878.3300

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

Depuy, Inc. · FTM Mesh, Surgical

Cleared on Sep 25, 1998 as substantially equivalent to K970561 (Organogenesis, Inc., 1997) and 4 other predicates after an 85-day review. Its family tree reaches back 3 generations to 1992. 92 later devices descend from it.

Decided
Sep 25, 1998
Review
85 days
Class
Class II
Product code
FTM
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K921895 (1992). 8 ancestors in all, the oldest K830889 (1983). 92 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 2 other ancestors1997: 1 other ancestor1992: 1 other ancestor1983: 1 other ancestor2008: 7 descendants cleared2003: 1 descendant cleared2006: 5 descendants cleared2004: 1 descendant cleared2005: 2 descendants cleared2007: 5 descendants cleared2010: 6 descendants cleared2012: 8 descendants cleared2017: 5 descendants cleared2009: 7 descendants cleared2025: 6 descendants cleared2021: 3 descendants cleared2024: 4 descendants cleared2019: 1 descendant cleared2011: 8 descendants cleared2014: 5 descendants cleared2022: 3 descendants cleared2016: 3 descendants cleared2013: 3 descendants cleared2023: 3 descendants cleared2026: 4 descendants cleared2015: 2 descendants clearedK921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K980431 · Surgisis · Cook Biotech, Inc. · 199819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 9 descendants3 generations forward: 14 descendants4 generations forward: 17 descendants5 generations forward: 17 descendants6 generations forward: 17 descendants7 generations forward: 10 descendants8 generations forward: 5 descendants K980431 · Surgisis · Cook Biotech, Inc. · 1998K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 19920+5
  1. Root · 3 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 2 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. 1 generation backK980431 SurgisisCook Biotech, Inc. · 1998
  4. This deviceK982330 Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc. · 1998
  5. Descendant · cites it directly · 91 of its ownK031969 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003
  6. Descendant · 2 generations on · 72 of its ownK042809 CuffpatchOrganogenesis, Inc. · 2004
  7. Descendant · 2 generations on · 44 of its ownK052830 SportmeshArtimplant AB · 2006
  8. Descendant · 2 generations on · 41 of its ownK053562 Zimmer Collagen Repair PatchTissue Science Laboratories, Plc · 2006
  9. Descendant · 3 generations on · 35 of its ownK051766 OrthomendTei Biosciences, Inc. · 2005

Showing 5 of 92 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 22006: 52007: 52008: 72009: 72010: 62011: 82012: 82013: 32014: 52015: 22016: 32017: 52019: 12021: 32022: 32023: 32024: 42025: 62026: 4
2003high 8 (2011) · low 0 (2018)2026

Most influential descendants

Showing 5 of 92 · See all
  • K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003 · cites it directly91descendants
  • K042809CuffpatchOrganogenesis, Inc. · 2004 · 2 generations on72descendants
  • K052830SportmeshArtimplant AB · 2006 · 2 generations on44descendants
  • K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc · 2006 · 2 generations on41descendants
  • K051766OrthomendTei Biosciences, Inc. · 2005 · 3 generations on35descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K921895Tissue Patch, Tissue GraftBio-Vascular, Inc.1992—
−2K961810Supple Peri-Guard PericardiumBio-Vascular, Inc.1996—
−1K980431SurgisisCook Biotech, Inc.1998—
0 (this device)K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc.1998—
+1K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2003—
+2K042809CuffpatchOrganogenesis, Inc.2004—
+2K052830SportmeshArtimplant AB2006—
+2K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc2006—
+3K051766OrthomendTei Biosciences, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199210
199710
199820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200520
200650
200750
200870
200970
201060
201180
201280
201330
201450
201520
201630
201750
201910
202130
202230
202330
202440
202560
202640
FIG. 1 — Lineage of K982330, 1992–2026Source: 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 FTM? 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 FTM device

  1. #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 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? (5)

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
*K970561Graft Patch
Summary page 1
…e Implant COMMON NAME: Surgical Mesh CLASSIFICATION: 878.3300 - Surgical Mesh DEVICE PRODUCT CODE: 79 FTM SUBSTANTIALLY EQUIVALENT DEVICES: ¢ Organogenesis Graft Patch (K970561) ¢ Sentron SIS Hernia Repair Device (K974540) ¢ Bio-Vascular Supple Peri-guard (K923657) ¢ Cook Biotech Inc. SIS Wound Dressing (…
Organogenesis, Inc.1997—
*K974540Sis Hernia Repair Device
Summary page 1
…CATION: 878.3300 - Surgical Mesh DEVICE PRODUCT CODE: 79 FTM SUBSTANTIALLY EQUIVALENT DEVICES: ¢ Organogenesis Graft Patch (K970561) ¢ Sentron SIS Hernia Repair Device (K974540) ¢ Bio-Vascular Supple Peri-guard (K923657) ¢ Cook Biotech Inc. SIS Wound Dressing (K973170) ¢ Cook Biotech Inc. SIS Surgical Mes…
Sentron Medical, Inc.1998—
*K923657Supple Peri-Guard
Summary page 1
…DUCT CODE: 79 FTM SUBSTANTIALLY EQUIVALENT DEVICES: ¢ Organogenesis Graft Patch (K970561) ¢ Sentron SIS Hernia Repair Device (K974540) ¢ Bio-Vascular Supple Peri-guard (K923657) ¢ Cook Biotech Inc. SIS Wound Dressing (K973170) ¢ Cook Biotech Inc. SIS Surgical Mesh (K980431) DEVICE DESCRIPTION AND INTENDE…
Bio-Vascular, Inc.1992—
*K973170Sis Wound Dressing
Summary page 1
…ES: ¢ Organogenesis Graft Patch (K970561) ¢ Sentron SIS Hernia Repair Device (K974540) ¢ Bio-Vascular Supple Peri-guard (K923657) ¢ Cook Biotech Inc. SIS Wound Dressing (K973170) ¢ Cook Biotech Inc. SIS Surgical Mesh (K980431) DEVICE DESCRIPTION AND INTENDED USE: The Restore Orthebiologic Soft Tissue Imp…
Cook Biotech, Inc.1998—
*K980431Surgisis
Summary page 1
…ron SIS Hernia Repair Device (K974540) ¢ Bio-Vascular Supple Peri-guard (K923657) ¢ Cook Biotech Inc. SIS Wound Dressing (K973170) ¢ Cook Biotech Inc. SIS Surgical Mesh (K980431) DEVICE DESCRIPTION AND INTENDED USE: The Restore Orthebiologic Soft Tissue Implant is a round device, manufactured from 10 ply…
Cook Biotech, Inc.1998—

Also cleared against K970561: 4 other devices →

What descends from it? (92)

See all 92

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

NumberDeviceApplicantDecidedDescendants
K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200391
K061892Propatch Soft Tissue Repair MatrixCryolife, Inc.200617
K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082

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?

  • The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K031969 (DePuy Orthopaedics, Inc., 2003) has gone furthest, with 91 descendants of its own.
  • 4 other devices also cite its predicate K970561.

How does its category compare?

All FTM devices

FTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTM

1in 2025

2007: 92008: 92009: 72010: 22011: 62012: 42013: 42014: 82015: 42016: 72017: 92018: 22019: 62020: 42021: 42023: 22024: 32025: 12026 (partial year): 1
2007high 9 (2007) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTM

29in 2024

2007: 104 days median2008: 86 days median2009: 86 days median2011: 100 days median2012: 66 days median2013: 123 days median2014: 153 days median2015: 316 days median2016: 88 days median2017: 147 days median2019: 107 days median2020: 59 days median2021: 61 days median2024: 29 days median
2007high 316 (2015) · low 29 (2024)2026

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

Recalls per year · FTM

1in 2023

2007: 72008: 12010: 12011: 82018: 212019: 42020: 12021: 12023: 1
2007high 21 (2018) · low 0 (2009)2026

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

Adverse event reports per year · FTM

232in 2025

2007: 602008: 1412009: 4762010: 1972011: 2882012: 4672013: 3,3512014: 1,0932015: 9772016: 5092017: 5292018: 3572019: 4182020: 4572021: 3692022: 3752023: 4852024: 3832025: 232
2007high 3,351 (2013) · low 60 (2007)2025

MAUDE reports naming product code FTM, 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
20079104760
20089861141
20097860476
20102—1197
201161008288
20124660467
2013412303,351
2014815301,093
201543160977
20167880509
201791470529
20182—21357
201961074418
20204591457
20214611369
20220—0375
20232—1485
20243290383
20251—0232
20261—0—

What is it indicated for?

The DePuy OrthoTech Restore Orthobiologic Soft Tissue Implant is intended for use in

general surgical procedures for reinforcement of soft tissue where weakness exists.

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

Also cleared against K970561

4 other devices cite the same predicate.

  • K021107Fortaflex Surgical SlingOrganogenesis, Inc. · 2002
  • K021105Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
  • K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  • K980431SurgisisCook Biotech, Inc. · 1998

More from Depuy, Inc.

719 FDA decisions under this applicant name. See the company

  • P830055/S379ATTUNE Revision Knee SystemDepuy, Inc. · 2026
  • P830055/S377ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Revision Rotating Platform (RP) Total Knee System…Depuy, Inc. · 2026
  • P830055/S380LCS® Total Knee SystemDepuy, Inc. · 2026
  • P830055/S375LCS® Total Knee SystemDepuy, Inc. · 2026
  • P830055/S351Attune Revision Knee SystemDepuy, Inc. · 2026

Recent decisions in FTM

The FTM category page

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https://510kreport.com/device/K982330 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982330: Depuy Orthotech Restore Orthobiologic Soft Tissue Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982330

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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