510(k) · Cleared
ClearedCuffpatch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organogenesis, Inc. · FTM Mesh, Surgical
Cleared on Nov 2, 2004 as substantially equivalent to K020049 (Organogenesis, Inc., 2002) and 2 other predicates after a 21-day review. Its family tree reaches back 6 generations to 1992. 72 later devices descend from it.
- Decided
- Nov 2, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K921895 (1992). 27 ancestors in all, the oldest K830889 (1983). 72 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 4 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 3 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 2 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 1 generation backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- This deviceK042809 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 · cites it directly · 35 of its ownK051766 OrthomendTei Biosciences, Inc. · 2005
- Descendant · cites it directly · 28 of its ownK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- Descendant · 2 generations on · 17 of its ownK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K052830SportmeshArtimplant AB · 2006 · cites it directly44descendants
- K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc · 2006 · cites it directly41descendants
- K051766OrthomendTei Biosciences, Inc. · 2005 · cites it directly35descendants
- K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007 · cites it directly28descendants
- K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −5 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −4 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −3 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −2 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −1 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| 0 (this device) | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| +1 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| +1 | K053562 | Zimmer Collagen Repair Patch | Tissue Science Laboratories, Plc | 2006 | — |
| +1 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| +1 | K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | 2007 | — |
| +2 | K070961 | Biomerix Surgical Mesh, Model: RCR-01 | Biomerix Corporation | 2008 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 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? (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 |
|---|---|---|---|
| * | K020049 | Fortaflex Surgical MeshSummary page 1…T M Legally Marketed Devices To Which Substantial Equivalence Is Claimed To: CufflPatch is equivalent to the FortaFlex Surgical Mesh (Cuffi'atch"), K020049 and K01 1025, with respect to the materials, design, physical T M characteristics, performance characteristics and bi… | 2002 |
| * | K011025 | Fortaflex Surgical MeshSummary page 1…T M Legally Marketed Devices To Which Substantial Equivalence Is Claimed To: CufflPatch is equivalent to the FortaFlex Surgical Mesh (Cuffi'atch"), K020049 and K01 1025, with respect to the materials, design, physical T M characteristics, performance characteristics and biological attr… | 2001 |
| * | K031969 | Depuy Restore Orthobiologic Soft Tissue ImplantSummary page 1…cteristics, performance characteristics and biological attributes. The subject device is also substantially equivalent to the Restore® Orthobiologic Soft Tissue Implant, K031969 in intended use and performance characteristics. Device Description: CuffPatch"" consists of laminated sheets of porcine intesti… | 2003 |
What descends from it? (72)
See all 726 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 12 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K052830 (Artimplant AB, 2006) has gone furthest, with 44 descendants of its own.
- 4 other devices also cite its predicate K020049.
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?
CuffPatchTM surgical mesh is intended for 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. CuffPatchTM surgical mesh 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.…
Read the full statement (110 words)
CuffPatchTM surgical mesh is intended for 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.
CuffPatchTM surgical mesh 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. CuffPatchTM surgical mesh 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/K042809 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042809: Cuffpatch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042809
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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