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 Sep 4, 2007 as substantially equivalent to K031969 (DePuy Orthopaedics, Inc., 2003) and 2 other predicates after a 147-day review. Its family tree reaches back 8 generations to 1992. 13 later devices descend from it.
- Decided
- Sep 4, 2007
- Review
- 147 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K921895 (1992). 45 ancestors in all, the oldest K810428 (1981). 13 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 5 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 4 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 3 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 2 generations backK043388 Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc. · 2005
- 1 generation backK061892 Propatch Soft Tissue Repair MatrixCryolife, Inc. · 2006
- This deviceK071016 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 12 of its ownK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
- Descendant · 2 generations on · 11 of its ownK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
- Descendant · 3 generations on · 10 of its ownK131143 Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013
- Descendant · 3 generations on · 9 of its ownK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
- Descendant · 4 generations on · 4 of its ownK222978 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc. · 2008 · cites it directly12descendants
- K120019Collagen RibbonWrightmedicaltechnologyinc · 2012 · 2 generations on11descendants
- K131143Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013 · 3 generations on10descendants
- K151083BioBridge Collagen MatrixFibralign Corporation · 2016 · 3 generations on9descendants
- K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −7 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −5 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −4 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −2 | K043388 | Pegasus Biologics Orthadapt Surgical Mesh | Pegasus Biologics, Inc. | 2005 | — |
| −1 | K061892 | Propatch Soft Tissue Repair Matrix | Cryolife, Inc. | 2006 | — |
| 0 (this device) | K071016 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal… | American Medical Systems, Inc. | 2008 | — |
| +2 | K120019 | Collagen Ribbon | Wrightmedicaltechnologyinc | 2012 | — |
| +3 | K131143 | Trellis Collagen Ribbon | Wrightmedicaltechnologyinc | 2013 | — |
| +3 | K151083 | BioBridge Collagen Matrix | Fibralign Corporation | 2016 | — |
| +4 | K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K031969 | Depuy Restore Orthobiologic Soft Tissue ImplantSummary page 1…sh CLASSIFICATION: 21 CIFR §878.3300, Class II PRODUCT CODE: FTM SUBSTANTIALLY EQUIVALENT DEVICES: * DePuy Restore Orthobiologic Soft Tissue Implant (K031969) * Cryol-ife ProPatch Soft Tissue Repair Matrix (K0611892) * W.L. Gore Absorbable Mesh (K0336711) DEVICE DESCRIPTION AND INTE… | 2003 |
| * | K061892 | Propatch Soft Tissue Repair MatrixSummary page 1…own soft tissue. BASIS OF SUBSTANTIAL EQUIVALENCE: The DePuy Restore Orthobiologic Soft Tissue Implant is substantially equivalent to the above listed devices (K031 969, K061892, K033671) in that it is manufactured from the same material (S15) as K031 969, and has the same intended use and similar indicati… | 2006 |
| * | K033671 | Gore Bioabsorbable MeshSummary page 1…IVALENT DEVICES: * DePuy Restore Orthobiologic Soft Tissue Implant (K031969) * Cryol-ife ProPatch Soft Tissue Repair Matrix (K0611892) * W.L. Gore Absorbable Mesh (K0336711) DEVICE DESCRIPTION AND INTENDED USE: The DePuy Restore Orthobiologic Soft Tissue Implant is manufactured from porcine small int… | 2003 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6… | 2008 | 12 |
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 15 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 45 ancestors have a recall of any class.
- Of its descendants, K073219 (American Medical Systems, Inc., 2008) has gone furthest, with 12 descendants of its own.
- 7 other devices also cite its predicate K031969.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 to reinforce soft tissue where weakness exists, specifically for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, and other tendons. The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair…
Read the full statement (141 words)
The DePuy Restore Orthobiologic Soft Tissue Implant is intended to reinforce soft tissue
where weakness exists, specifically for the reinforcement of soft tissue repaired by
sutures or suture anchors during tendon repair surgery, including reinforcement of the
rotator cuff, patellar, Achilles, biceps, quadriceps, and other tendons. The device is not
intended to replace normal body structure or provide the full mechanical strength to
support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other
tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach
the tissue to the bone, provide biomechanical strength for the tendon repair. The DePuy
Restore Orthobiologic Soft Tissue Implant is also intended for use during general tissue
reconstruction of the periosteum. The device 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/K071016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071016: 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/K071016
Report an extraction error
Are you the manufacturer?
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