510(k) · Cleared
ClearedSynergy Tissue Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synovis Orthopedic & Woundcare · FTM Mesh, Surgical
Cleared on Jan 11, 2012 as substantially equivalent to K043388 (Pegasus Biologics, Inc., 2005) and 6 other predicates after a 50-day review. Its family tree reaches back 9 generations to 1985.
- Decided
- Jan 11, 2012
- Review
- 50 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 9 generations to K842066 (1985). 65 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 9 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 5 generations between
- 3 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 2 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 1 generation backK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
- This deviceK113460 Synergy Tissue MatrixSynovis Orthopedic & Woundcare · 2012
Show all 9 generations
- Root · 9 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 8 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 7 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 6 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 5 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 4 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 3 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 2 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 1 generation backK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
- This deviceK113460 Synergy Tissue MatrixSynovis Orthopedic & Woundcare · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −8 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −7 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −6 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −5 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −4 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −3 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −2 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −1 | K062915 | Veritas Collagen Matrix | Synovis Surgical Innovations | 2006 | 1 |
| 0 (this device) | K113460 | Synergy Tissue Matrix | Synovis Orthopedic & Woundcare | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 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? (8)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043388 | Pegasus Biologics Orthadapt Surgical MeshSummary page 1…llowing surgical mesh devices, which are cleared for commercial distribution in the United States: * OrthADAPT® Bioimplant, Pegasus Biologics, Inc., K043388, K(07 1065 * Veritas®)Collagen Matrix, Synovis Surgical Innovations, K002233, K030879, K0… | 2005 |
| * | K071065 | Orthadapt Bioimplant | 2007 |
| Kept off the family tree | K002233 | FDA’s K002233 is Bvi Sling Our reading of the summary gave K002233, FDA’s number for Bvi Sling (Bio-Vascular, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Veritas® Collagen Matrix”. Kept off the family tree. Summary page 1…tes: * OrthADAPT® Bioimplant, Pegasus Biologics, Inc., K043388, K(07 1065 * Veritas®)Collagen Matrix, Synovis Surgical Innovations, K002233, K030879, K06291 5 * CuffPatch®@ Surgical Mesh, Organogenesis, Inc. K042809… | 2000 |
| * | K030879 | Veritas Collagen MatrixSummary page 1…* OrthADAPT® Bioimplant, Pegasus Biologics, Inc., K043388, K(07 1065 * Veritas®)Collagen Matrix, Synovis Surgical Innovations, K002233, K030879, K06291 5 * CuffPatch®@ Surgical Mesh, Organogenesis, Inc. K042809 * P… | 2003 |
| * | K062915 | Veritas Collagen MatrixSummary page 1…oimplant, Pegasus Biologics, Inc., K043388, K(07 1065 * Veritas®)Collagen Matrix, Synovis Surgical Innovations, K002233, K030879, K06291 5 * CuffPatch®@ Surgical Mesh, Organogenesis, Inc. K042809 * PROPatch@ Soft Tissue Repair Mat… | 2006 |
| * | K042809 | CuffpatchSummary page 1…ritas®)Collagen Matrix, Synovis Surgical Innovations, K002233, K030879, K06291 5 * CuffPatch®@ Surgical Mesh, Organogenesis, Inc. K042809 * PROPatch@ Soft Tissue Repair Matrix, CryoLife, Inc., K061892, K101 587 4 Device Description Synerg… | 2004 |
| * | K061892 | Propatch Soft Tissue Repair MatrixSummary page 1…K06291 5 * CuffPatch®@ Surgical Mesh, Organogenesis, Inc. K042809 * PROPatch@ Soft Tissue Repair Matrix, CryoLife, Inc., K061892, K101 587 4 Device Description Synergy Tissue Matrix is an implantable biologic mesh comprised of non-crosslinked bovin… | 2006 |
| * | K101587 | Propatch Soft Tissue Repair MatrixSummary page 1…K06291 5 * CuffPatch®@ Surgical Mesh, Organogenesis, Inc. K042809 * PROPatch@ Soft Tissue Repair Matrix, CryoLife, Inc., K061892, K101 587 4 Device Description Synergy Tissue Matrix is an implantable biologic mesh comprised of non-crosslinked bovine perica… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 65 ancestors have a recall of any class.
- 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. 2012, 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?
Synergy Tm Tissue Matrix is intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures. The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles…
Read the full statement (128 words)
Synergy Tm Tissue Matrix is intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures.
The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
Synergy Tissue 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 biomnechanical strength for the tendon repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113460: Synergy Tissue Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113460
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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