510(k) Report

510(k) · Cleared

Cleared

Depuy Restore Orthobiologic Soft Tissue Implant

K001738510(k) TraditionalCleared Dec 27, 2000203-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 Orthopaedics, Inc. · FTM Mesh, Surgical

Cleared on Dec 27, 2000 as substantially equivalent to K980431 (Cook Biotech, Inc., 1998) and 6 other predicates after a 203-day review. Its family tree reaches back 4 generations to 1992. 173 later devices descend from it.

Decided
Dec 27, 2000
Review
203 days
Class
Class II
Product code
FTM
Recalls
None
Predicates
7

Its longest line of descent runs back 4 generations to K921895 (1992). 22 ancestors in all, the oldest K830889 (1983). 173 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1998: 5 other ancestors1997: 1 other ancestor1996: 3 other ancestors1992: 1 other ancestor1991: 3 other ancestors1985: 1 other ancestor1983: 1 other ancestor1993: 1 other ancestor1988: 1 other ancestor2006: 7 descendants cleared2002: 3 descendants cleared2003: 3 descendants cleared2008: 8 descendants cleared2005: 3 descendants cleared2004: 3 descendants cleared2010: 9 descendants cleared2009: 11 descendants cleared2007: 8 descendants cleared2017: 12 descendants cleared2015: 5 descendants cleared2018: 8 descendants cleared2013: 6 descendants cleared2012: 8 descendants cleared2016: 7 descendants cleared2025: 10 descendants cleared2021: 5 descendants cleared2011: 9 descendants cleared2019: 5 descendants cleared2014: 6 descendants cleared2023: 6 descendants cleared2026: 10 descendants cleared2022: 7 descendants cleared2024: 12 descendants cleared2020: 2 descendants clearedReference device: K982330 · Depuy Orthotech Restore Orthobiologic Soft Tissue Implant · Depuy, Inc. · 1998K921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K980431 · Surgisis · Cook Biotech, Inc. · 1998K992159 · Surgisis Sling · Cook Biotech, Inc. · 199919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 10 other ancestors3 generations back: 3 other ancestors 1 generation forward: 10 descendants2 generations forward: 29 descendants3 generations forward: 46 descendants4 generations forward: 36 descendants5 generations forward: 38 descendants6 generations forward: 10 descendants7 generations forward: 4 descendants K992159 · Surgisis Sling · Cook Biotech, Inc. · 1999K980431 · Surgisis · Cook Biotech, Inc. · 1998K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 19920+5
  1. Root · 4 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 3 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. 2 generations backK980431 SurgisisCook Biotech, Inc. · 1998
  4. 1 generation backK992159 Surgisis SlingCook Biotech, Inc. · 1999
  5. This deviceK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  6. Descendant · cites it directly · 102 of its ownK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
  7. Descendant · cites it directly · 91 of its ownK031969 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003
  8. Descendant · 2 generations on · 72 of its ownK042809 CuffpatchOrganogenesis, Inc. · 2004
  9. Descendant · cites it directly · 51 of its ownK021056 PermacolTissue Science Laboratories, Plc · 2002
  10. Descendant · cites it directly · 49 of its ownK043388 Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc. · 2005

Showing 5 of 173 descendants. See all descendants

Descendants cleared per year

2002: 32003: 32004: 32005: 32006: 72007: 82008: 82009: 112010: 92011: 92012: 82013: 62014: 62015: 52016: 72017: 122018: 82019: 52020: 22021: 52022: 72023: 62024: 122025: 102026: 10
2002high 12 (2017) · low 2 (2020)2026

Most influential descendants

Showing 5 of 173 · See all
  • K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · cites it directly102descendants
  • K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003 · cites it directly91descendants
  • K042809CuffpatchOrganogenesis, Inc. · 2004 · 2 generations on72descendants
  • K021056PermacolTissue Science Laboratories, Plc · 2002 · cites it directly51descendants
  • K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc. · 2005 · cites it directly49descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K921895Tissue Patch, Tissue GraftBio-Vascular, Inc.1992—
−3K961810Supple Peri-Guard PericardiumBio-Vascular, Inc.1996—
−2K980431SurgisisCook Biotech, Inc.1998—
−1K992159Surgisis SlingCook Biotech, Inc.1999—
0 (this device)K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000—
+1K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002—
+1K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2003—
+2K042809CuffpatchOrganogenesis, Inc.2004—
+1K021056PermacolTissue Science Laboratories, Plc2002—
+1K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198510
198810
199130
199210
199310
199630
199710
199850
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200330
200430
200530
200670
200780
200880
2009110
201090
201190
201280
201360
201460
201550
201670
2017120
201880
201950
202020
202150
202270
202360
2024120
2025100
2026100
FIG. 1 — Lineage of K001738, 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? (7)

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
*K980431Surgisis
Summary page 1
…NAME: Surgical Mesh CLASSIFICATION: 878.3300 — Surgical Mesh DEVICE PRODUCT CODE: 79 FTM SUBSTANTIALLY EQUIVALENT DEVICES: ‘ ¢ Cook Biotech Inc. Surgisis Surgical Mesh (K980431) ¢ Cook Biotech Inc. SIS Wound Dressing (K973170) ¢ Cook Biotech Inc. SIS Wound Dressing IT (K993948) + Cook Biotech Inc. Surgisi…
Cook Biotech, Inc.1998—
*K973170Sis Wound Dressing
Summary page 1
…rgical Mesh DEVICE PRODUCT CODE: 79 FTM SUBSTANTIALLY EQUIVALENT DEVICES: ‘ ¢ Cook Biotech Inc. Surgisis Surgical Mesh (K980431) ¢ Cook Biotech Inc. SIS Wound Dressing (K973170) ¢ Cook Biotech Inc. SIS Wound Dressing IT (K993948) + Cook Biotech Inc. Surgisis Sling (K992159) ¢ Bio-Vascular Peri-guard (K983…
Cook Biotech, Inc.1998—
*K993948Sis Wound Dressing II
Summary page 1
…LY EQUIVALENT DEVICES: ‘ ¢ Cook Biotech Inc. Surgisis Surgical Mesh (K980431) ¢ Cook Biotech Inc. SIS Wound Dressing (K973170) ¢ Cook Biotech Inc. SIS Wound Dressing IT (K993948) + Cook Biotech Inc. Surgisis Sling (K992159) ¢ Bio-Vascular Peri-guard (K983162) ¢ Bio-Vascular Peri-Strips (K992159) # Organoge…
Cook Biotech, Inc.2000—
*K992159Surgisis Sling
Summary page 1
…Surgisis Surgical Mesh (K980431) ¢ Cook Biotech Inc. SIS Wound Dressing (K973170) ¢ Cook Biotech Inc. SIS Wound Dressing IT (K993948) + Cook Biotech Inc. Surgisis Sling (K992159) ¢ Bio-Vascular Peri-guard (K983162) ¢ Bio-Vascular Peri-Strips (K992159) # Organogenesis Graft Patch (K970561) + Sentron SIS Hem…
Cook Biotech, Inc.1999—
*K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…
Summary page 1
…ook Biotech Inc. SIS Wound Dressing (K973170) ¢ Cook Biotech Inc. SIS Wound Dressing IT (K993948) + Cook Biotech Inc. Surgisis Sling (K992159) ¢ Bio-Vascular Peri-guard (K983162) ¢ Bio-Vascular Peri-Strips (K992159) # Organogenesis Graft Patch (K970561) + Sentron SIS Hemia Repair Device (K974540) DEVICE D…
Bio-Vascular, Inc.19982
*K970561Graft Patch
Summary page 1
…Dressing IT (K993948) + Cook Biotech Inc. Surgisis Sling (K992159) ¢ Bio-Vascular Peri-guard (K983162) ¢ Bio-Vascular Peri-Strips (K992159) # Organogenesis Graft Patch (K970561) + Sentron SIS Hemia Repair Device (K974540) DEVICE DESCRIPTION AND INTENDED USE: The Restore Orthobiologic Soft Tissue Implant…
Organogenesis, Inc.1997—
*K974540Sis Hernia Repair Device
Summary page 1
…urgisis Sling (K992159) ¢ Bio-Vascular Peri-guard (K983162) ¢ Bio-Vascular Peri-Strips (K992159) # Organogenesis Graft Patch (K970561) + Sentron SIS Hemia Repair Device (K974540) DEVICE DESCRIPTION AND INTENDED USE: The Restore Orthobiologic Soft Tissue Implant is a round device, manufactured from 10 ply…
Sentron Medical, Inc.1998—
†K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc.1998—

Also cleared against K980431: 28 other devices →

What descends from it? (173)

See all 173

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

NumberDeviceApplicantDecidedDescendants
K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002102
K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200391
K021056PermacolTissue Science Laboratories, Plc200251
K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc.200549
K021637Acell Ubm Lyophilized Wound DressingAcell, Inc.200245
K052830SportmeshArtimplant AB200644
K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc.200339
K031188OrthomendTei Biosciences, Inc.200336
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 8 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
  • 1 of the 22 ancestors has a recall of any class.
  • Of its descendants, K020049 (Organogenesis, Inc., 2002) has gone furthest, with 102 descendants of its own.
  • 28 other devices also cite its predicate K980431.

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 Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. In addition, the implant is intended for use in the specific application of reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.

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 K980431

28 other devices cite the same predicate.

  • K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue GraftCook Biotech Incorporated · 2019
  • K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2016
  • K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated · 20161 recall
  • K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 20142 recalls
  • K134033Miromatrix Biological MeshMiromatrix Medical, Inc. · 2014
  • K130547Endoform Reconstructive TemplateMesynthe, Ltd. · 2013

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

Recent decisions in FTM

The FTM category page

  • K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific · 2026
  • K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd. · 2025
  • K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc. · 2024
  • K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc. · 2024
  • K241126OviTex PRSTELA Bio, Inc. · 2024

https://510kreport.com/device/K001738 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001738: Depuy 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/K001738

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026