510(k) · Cleared
ClearedPropatch Soft Tissue Repair Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryolife, Inc. · FTM Mesh, Surgical
Cleared on Nov 22, 2006 as substantially equivalent to K043388 (Pegasus Biologics, Inc., 2005) and 3 other predicates after a 142-day review. Its family tree reaches back 7 generations to 1992. 17 later devices descend from it.
- Decided
- Nov 22, 2006
- Review
- 142 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K921895 (1992). 28 ancestors in all, the oldest K830889 (1983). 17 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 5 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 4 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 3 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 2 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 1 generation backK043388 Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc. · 2005
- This deviceK061892 Propatch Soft Tissue Repair MatrixCryolife, Inc. · 2006
- Descendant · cites it directly · 13 of its ownK071016 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2007
- Descendant · 2 generations on · 12 of its ownK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
- Descendant · 3 generations on · 11 of its ownK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
- Descendant · 4 generations on · 10 of its ownK131143 Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013
- Descendant · 4 generations on · 9 of its ownK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2007 · cites it directly13descendants
- K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc. · 2008 · 2 generations on12descendants
- K120019Collagen RibbonWrightmedicaltechnologyinc · 2012 · 3 generations on11descendants
- K131143Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013 · 4 generations on10descendants
- K151083BioBridge Collagen MatrixFibralign Corporation · 2016 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −6 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −5 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −4 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −3 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −1 | K043388 | Pegasus Biologics Orthadapt Surgical Mesh | Pegasus Biologics, Inc. | 2005 | — |
| 0 (this device) | K061892 | Propatch Soft Tissue Repair Matrix | Cryolife, Inc. | 2006 | — |
| +1 | K071016 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2007 | — |
| +2 | K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal… | American Medical Systems, Inc. | 2008 | — |
| +3 | K120019 | Collagen Ribbon | Wrightmedicaltechnologyinc | 2012 | — |
| +4 | K131143 | Trellis Collagen Ribbon | Wrightmedicaltechnologyinc | 2013 | — |
| +4 | K151083 | BioBridge Collagen Matrix | Fibralign Corporation | 2016 | — |
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 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043388 | Pegasus Biologics Orthadapt Surgical MeshSummary page 1…e. Predicate Devices:l o 4 ‘ 510 (k) Number(s), | Product ~ Device’ . |- . Company. s “Clearance Date | "Code- Pegasus Biologics : . ™ g"ml’l Q:T 6 Jenner, Suite 150 KO043388 — 08/05/2005 FIM P Irvine, CA 92618 ® L Depuy Orthopaedics, Inc. K031969 - 07/28/2003 g:;:?rr; su‘:’;:‘:‘i;‘;‘l"gw 700 Orthopaedi… | 2005 |
| * | K031969 | Depuy Restore Orthobiologic Soft Tissue ImplantSummary page 1…|- . Company. s “Clearance Date | "Code- Pegasus Biologics : . ™ g"ml’l Q:T 6 Jenner, Suite 150 KO043388 — 08/05/2005 FIM P Irvine, CA 92618 ® L Depuy Orthopaedics, Inc. K031969 - 07/28/2003 g:;:?rr; su‘:’;:‘:‘i;‘;‘l"gw 700 Orthopaedic Drive K001738 — 12/27/2000 FTM p Warsaw, IN 46581 K982330 - 09/25/1998… | 2003 |
| * | K001738 | Depuy Restore Orthobiologic Soft Tissue ImplantSummary page 1…Q:T 6 Jenner, Suite 150 KO043388 — 08/05/2005 FIM P Irvine, CA 92618 ® L Depuy Orthopaedics, Inc. K031969 - 07/28/2003 g:;:?rr; su‘:’;:‘:‘i;‘;‘l"gw 700 Orthopaedic Drive K001738 — 12/27/2000 FTM p Warsaw, IN 46581 K982330 - 09/25/1998 Device Description: ProPatch™ Soft Tissue Repair Matrix is an acelluar… | 2000 |
| * | K982330 | Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantSummary page 1…5 FIM P Irvine, CA 92618 ® L Depuy Orthopaedics, Inc. K031969 - 07/28/2003 g:;:?rr; su‘:’;:‘:‘i;‘;‘l"gw 700 Orthopaedic Drive K001738 — 12/27/2000 FTM p Warsaw, IN 46581 K982330 - 09/25/1998 Device Description: ProPatch™ Soft Tissue Repair Matrix is an acelluar bovine pericardia based surgical mesh. Prod… | 1998 |
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K071016 (DePuy Orthopaedics, Inc., 2007) has gone furthest, with 13 descendants of its own.
- 3 other devices also cite its predicate K043388.
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?
ProPatch Soft Tissue Repair Matrix is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures. ProPatch Soft Tissue Repair Matrix is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including…
Read the full statement (155 words)
ProPatch Soft Tissue Repair Matrix is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures.
ProPatch Soft Tissue Repair Matrix is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
ProPatch Soft Tissue Repair Matrix 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. ProPatch Soft Tissue Repair Matrix reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient’s own soft tissue.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061892 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061892: Propatch Soft Tissue Repair Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061892
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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