510(k) · Cleared
ClearedCollagen Ribbon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · FTM Mesh, Surgical
Cleared on Feb 23, 2012 as substantially equivalent to K073219 (American Medical Systems, Inc., 2008) after a 51-day review. Its family tree reaches back 11 generations to 1993. 11 later devices descend from it.
- Decided
- Feb 23, 2012
- Review
- 51 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K931386 (1993). 76 ancestors in all, the oldest K810428 (1981). 11 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 7 generations between
- 3 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 2 generations backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
- 1 generation backK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
- This deviceK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
- Descendant · cites it directly · 10 of its ownK131143 Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013
- Descendant · cites it directly · 9 of its ownK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
- Descendant · 2 generations on · 4 of its ownK222978 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK230316 FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 2023 · Recalled
- Descendant · 3 generations on · 2 of its ownK251063 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025
Show all 11 generations
- Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 10 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 9 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 8 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 7 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 6 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 5 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 4 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 3 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 2 generations backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
- 1 generation backK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
- This deviceK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K131143Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013 · cites it directly10descendants
- K151083BioBridge Collagen MatrixFibralign Corporation · 2016 · cites it directly9descendants
- K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 2 generations on4descendants
- K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 2023 · 2 generations on3descendants
- K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −10 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −9 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −8 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −7 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −6 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −5 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −4 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −3 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −2 | K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | 2005 | 1 |
| −1 | K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal… | American Medical Systems, Inc. | 2008 | — |
| 0 (this device) | K120019 | Collagen Ribbon | Wrightmedicaltechnologyinc | 2012 | — |
| +1 | K131143 | Trellis Collagen Ribbon | Wrightmedicaltechnologyinc | 2013 | — |
| +1 | K151083 | BioBridge Collagen Matrix | Fibralign Corporation | 2016 | — |
| +2 | K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| +2 | K230316 | FlexBand; FlexPatch; FlexBand Plus | International Life Sciences | 2023 | 3 |
| +3 | K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025 | — |
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 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 8 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 8 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…Summary page 1…21 CER 878.3300 - Class 11 Device Product Code and Panel Code: FTM: Surgical Mesh (a)(3). Predicate Device: K073219 - WMT Collagen Ribbon (a)(4). Device Description The subject Collagen Ribbon Tissue Matrix is a narrow, ribbon-like vers… | 2008 |
What descends from it? (11)
See all 112 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 19 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 7 of the 76 ancestors have a recall of any class.
- Of its descendants, K131143 (Wrightmedicaltechnologyinc, 2013) has gone furthest, with 10 descendants of its own.
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?
The Collagen Ribbon Tissue Matrix 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, peroneal, posterial tibial, and other tendons. The Collagen Ribbon Tissue Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair. Sutures used to repair the tear and suture or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120019 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120019: Collagen Ribbon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120019
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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