510(k) · Cleared
ClearedBioBrace® Extra-Articular Ligament Augmentation Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Oct 15, 2025 as substantially equivalent to K244025 (Conmed Corporation, 2025) and 2 other predicates after a 30-day review. Its family tree reaches back 16 generations to 1993.
- Decided
- Oct 15, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K931386 (1993). 192 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 16 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 12 generations between
- 3 generations backK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
- 2 generations backK230316 FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 2023 · Recalled
- 1 generation backK242187 BioBrace®Conmed Corporation · 2024
- This deviceK252946 BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025
Show all 16 generations
- Root · 16 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 15 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 14 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 13 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 12 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 11 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 10 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 9 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 8 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 7 generations backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
- 6 generations backK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
- 5 generations backK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
- 4 generations backK131143 Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013
- 3 generations backK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
- 2 generations backK230316 FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 2023 · Recalled
- 1 generation backK242187 BioBrace®Conmed Corporation · 2024
- This deviceK252946 BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −15 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −14 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −13 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −12 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −11 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −10 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −9 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −8 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −7 | K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | 2005 | 1 |
| −6 | K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal… | American Medical Systems, Inc. | 2008 | — |
| −5 | K120019 | Collagen Ribbon | Wrightmedicaltechnologyinc | 2012 | — |
| −4 | K131143 | Trellis Collagen Ribbon | Wrightmedicaltechnologyinc | 2013 | — |
| −3 | K151083 | BioBridge Collagen Matrix | Fibralign Corporation | 2016 | — |
| −2 | K230316 | FlexBand; FlexPatch; FlexBand Plus | International Life Sciences | 2023 | 3 |
| −1 | K242187 | BioBrace® | Conmed Corporation | 2024 | — |
| 0 (this device) | K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 7 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 8 | 0 |
| 1996 | 20 | 0 |
| 1997 | 14 | 0 |
| 1998 | 15 | 0 |
| 1999 | 8 | 0 |
| 2000 | 14 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 6 | 0 |
| 2004 | 11 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 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 |
|---|---|---|---|
| * | K244025 | Argo Knotless GENESYS AnchorSummary page 5…accessories Surgical Mesh Product Code: MAI, OWW, OWY III. PREDICATE DEVICES 510K#: K244025 Device: Argo Knotless® ™Anchor Common Name: Fastener, fixation, biodegradable, soft tissue Regulator… | 2025 |
| * | K240090 | Argo Knotless GENESYS AnchorSummary page 6…tallic bone fixation appliance and accessories Product Code: MAI, MBI Additional Predicate: 510K#: K240090 Device:Argo Knotless® Anchor Common Name: Fastener, fixation, biodegradable, soft tissue Regulatory Class: Class… | 2024 |
| * | K242187 | BioBrace®Summary page 6…etallic bone fixation appliance and accessories Product Code: MAI, MBI Additional Predicate: 510K#: K242187 Device: BioBrace® Common Name: Surgical Mesh Regulatory Class: Class II,… | 2024 |
| † | K180763 | CuffLink Implant System Biocomposite | 2018 |
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 32 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 16 of the 192 ancestors have a recall of any class.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The BioBrace® Extra-Articular Ligament Augmentation Kit is intended to reattach soft tissue to bone and reinforce soft tissue where weakness exists in extra-articular knee ligament surgical procedures. The Argo Knotless® GENE SYS TM Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture…
Read the full statement (174 words)
The BioBrace® Extra-Articular Ligament Augmentation Kit is intended to reattach soft tissue to bone and reinforce soft tissue where weakness exists in extra-articular knee ligament surgical procedures.
The Argo Knotless® GENE SYS TM Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period .
The BioBrace® Reinforced Biolnductive Implant is intended for reinforcement of soft tissues that are repaired by suture or suture anchors during knee repair surgery including reinforcement of patellar ligament, medial collateral ligament, lateral collateral ligament or other knee extra-articular ligaments. It is not intended to replace normal body structures or provide the full mechanical strength to the repair. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252946 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252946: BioBrace® Extra-Articular Ligament Augmentation Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252946
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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