510(k) · Cleared
ClearedDepuy Restore Orthobiologic Soft Tissue Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · FTM Mesh, Surgical
Cleared on Jul 28, 2003 as substantially equivalent to K982330 (Depuy, Inc., 1998) and 1 other predicate after a 32-day review. Its family tree reaches back 5 generations to 1992. 91 later devices descend from it.
- Decided
- Jul 28, 2003
- Review
- 32 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K921895 (1992). 24 ancestors in all, the oldest K830889 (1983). 91 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 4 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 3 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 2 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 1 generation backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- This deviceK031969 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003
- Descendant · cites it directly · 72 of its ownK042809 CuffpatchOrganogenesis, Inc. · 2004
- Descendant · cites it directly · 44 of its ownK052830 SportmeshArtimplant AB · 2006
- Descendant · cites it directly · 41 of its ownK053562 Zimmer Collagen Repair PatchTissue Science Laboratories, Plc · 2006
- Descendant · 2 generations on · 35 of its ownK051766 OrthomendTei Biosciences, Inc. · 2005
- Descendant · 2 generations on · 28 of its ownK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K042809CuffpatchOrganogenesis, Inc. · 2004 · cites it directly72descendants
- K052830SportmeshArtimplant AB · 2006 · cites it directly44descendants
- K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc · 2006 · cites it directly41descendants
- K051766OrthomendTei Biosciences, Inc. · 2005 · 2 generations on35descendants
- K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007 · 2 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −4 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −3 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −2 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −1 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| 0 (this device) | K031969 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2003 | — |
| +1 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| +1 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| +1 | K053562 | Zimmer Collagen Repair Patch | Tissue Science Laboratories, Plc | 2006 | — |
| +2 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| +2 | K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 6 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 8 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 0 |
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 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K982330 | Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantSummary page 1…atient’s own soft tissue. BASIS OF SUBSTANTIAL EQUIVALENCE: The DePuy Restore@Orthobiologic Soft Tissue Implant is substantially equivalent to the above listed device (K982330, KOO1738) in that it is manufactured from the same material (SIS, porcine small intestine submucosa), has the same device design,… | 1998 |
| * | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | 2000 |
What descends from it? (91)
See all 918 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042809 | Cuffpatch | 2004 | 72 |
| K052830 | Sportmesh | 2006 | 44 |
| K053562 | Zimmer Collagen Repair Patch | 2006 | 41 |
| K070961 | Biomerix Surgical Mesh, Model: RCR-01 | 2008 | 17 |
| K061892 | Propatch Soft Tissue Repair Matrix | 2006 | 17 |
| K071016 | Depuy Restore Orthobiologic Soft Tissue Implant | 2007 | 13 |
| K043259 | Bioblanket Surgical Mesh | 2005 | 10 |
| K082079 | Regen Collagen Scaffold (CS) | 2008 | 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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K042809 (Organogenesis, Inc., 2004) has gone furthest, with 72 descendants of its own.
- 2 other devices also cite its predicate K982330.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 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, during rotator cuff repair surgery. The Restore@Implant is not intended to replace normal body structure or provide the full mechanical…
Read the full statement (118 words)
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, during rotator cuff repair surgery.
The Restore@Implant is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures to repair the tear and suture or bone anchors to reattach the tissue to the bone provide mechanical strength for the rotator cuff repair. The Restore@Implant reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient’s own soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031969 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031969: 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/K031969
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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