510(k) · Cleared
ClearedBioBridge Collagen Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fibralign Corporation · OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Cleared on Jan 8, 2016 as substantially equivalent to K131143 (Wrightmedicaltechnologyinc, 2013) and 3 other predicates after a 261-day review. Its family tree reaches back 13 generations to 1993. 9 later devices descend from it.
- Decided
- Jan 8, 2016
- Review
- 261 days
- Class
- Class II
- Product code
- OWY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K931386 (1993). 92 ancestors in all, the oldest K810428 (1981). 9 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 9 generations between
- 3 generations backK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
- 2 generations backK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
- 1 generation backK131143 Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013
- This deviceK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
- Descendant · cites it directly · 4 of its ownK222978 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- Descendant · cites it directly · 3 of its ownK230316 FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 2023 · Recalled
- Descendant · 2 generations on · 2 of its ownK251063 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025
- Descendant · 2 generations on · 1 of its ownK261621 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026
- Descendant · 2 generations on · 1 of its ownK242187 BioBrace®Conmed Corporation · 2024
Show all 13 generations
- Root · 13 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 12 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 11 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 10 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 9 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 8 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 7 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 6 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 5 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 4 generations backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
- 3 generations backK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
- 2 generations backK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
- 1 generation backK131143 Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013
- This deviceK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · cites it directly4descendants
- K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 2023 · cites it directly3descendants
- K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025 · 2 generations on2descendants
- K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026 · 2 generations on1descendant
- K242187BioBrace®Conmed Corporation · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −12 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −11 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −10 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −9 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −8 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −7 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −6 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −5 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −4 | K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | 2005 | 1 |
| −3 | 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 | — |
| −1 | K131143 | Trellis Collagen Ribbon | Wrightmedicaltechnologyinc | 2013 | — |
| 0 (this device) | K151083 | BioBridge Collagen Matrix | Fibralign Corporation | 2016 | — |
| +1 | K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| +1 | K230316 | FlexBand; FlexPatch; FlexBand Plus | International Life Sciences | 2023 | 3 |
| +2 | K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025 | — |
| +2 | K261621 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026 | — |
| +2 | K242187 | BioBrace® | Conmed Corporation | 2024 | — |
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 | 4 | 0 |
| 1998 | 8 | 0 |
| 1999 | 2 | 0 |
| 2000 | 9 | 0 |
| 2001 | 5 | 0 |
| 2002 | 9 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OWY? 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 OWY device
- #1 K222501 Regeneten Bioinductive Implantscore 13.1 · 7 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 |
|---|---|---|---|
| * | K131143 | Trellis Collagen RibbonSummary page 5…10(k) SUMMARY III. PREDICATE DEVICES [807.92(a)(3)] Primary predicate device: TRELLIS™ Collagen Ribbon – Wright Medical Technology, Inc. (K131143; K120019) Additional predicate device: HP Tissue Matrix (HPTM)– LifeCell Corporation (K142326; K08)… | 2013 |
| * | K120019 | Collagen RibbonSummary page 5…MARY III. PREDICATE DEVICES [807.92(a)(3)] Primary predicate device: TRELLIS™ Collagen Ribbon – Wright Medical Technology, Inc. (K131143; K120019) Additional predicate device: HP Tissue Matrix (HPTM)– LifeCell Corporation (K142326; K08)… | 2012 |
| * | K142326 | HP Tissue MatrixSummary page 5…Wright Medical Technology, Inc. (K131143; K120019) Additional predicate device: HP Tissue Matrix (HPTM)– LifeCell Corporation (K142326; K08) Reference device: Ossix™ Plus – ColBar LifeSciences Ltd. (K053260) The ColBar Ossix Plus device is inc… | 2014 |
| * | K082176 | LTM-BPS Surgical MeshSummary page 6…use of the device as compared to this predicate. In addition, BioBridge is comparable with respect to intended use to the LifeCell HPTM device (K142326; K082176) which is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repa… | 2008 |
| † | K053260 | Ossix -Plus | 2006 |
What descends from it? (9)
2 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 23 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 92 ancestors have a recall of any class.
- Of its descendants, K222978 (Xiros, Ltd., 2022) has gone furthest, with 4 descendants of its own.
How does its category compare?
All OWY devicesOWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OWY
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWY
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWY
No recall names OWY since 2007.
Adverse event reports per year · OWY
28in 2025
MAUDE reports naming product code OWY, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 1 | — | 0 | 14 |
| 2021 | 1 | — | 0 | 25 |
| 2022 | 1 | — | 0 | 15 |
| 2023 | 1 | — | 0 | 35 |
| 2024 | 1 | — | 0 | 24 |
| 2025 | 4 | 131 | 0 | 28 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BioBridge™ Collagen Matrix is intended to reinforce soft tissue where weakness and deficiencies exist, specifically, for reinforcement of soft tissue repaired by sutures or suture anchors in tendon repair, including small tendons, ligaments, and general surgical procedures for tissue repair where weakness exists, including muscle flap reinforcement.
BioBridge is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair,
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/K151083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151083: BioBridge Collagen Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151083
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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