510(k) · Cleared
ClearedExpressBraid Graft Manipulation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Feb 8, 2016 as substantially equivalent to K122374 (Arthrex, Inc., 2012) after a 131-day review. Its family tree reaches back 8 generations to 1990. 2 later devices descend from it.
- Decided
- Feb 8, 2016
- Review
- 131 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K904436 (1990). 32 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 7 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 6 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 5 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 4 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- 3 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- 2 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 1 generation backK122374 Arthrex Suture (Uhmwpe)Arthrex, Inc. · 2012
- This deviceK152868 ExpressBraid Graft ManipulationBiomet Manufacturing Corp · 2016
- Descendant · cites it directly · 0 of its ownK163651 ExpressBraid Graft ManipulationBiomet Manufacturing Corp · 2017
- Descendant · cites it directly · 0 of its ownK160854 MaxBraid BroadBand Suture and Expressbraid BroadBand Graft…Biomet Manafacturing Corp. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −7 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −6 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −5 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −4 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| −3 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| −2 | K100652 | Acl Tightrope | Arthrex, Inc. | 2010 | — |
| −1 | K122374 | Arthrex Suture (Uhmwpe) | Arthrex, Inc. | 2012 | — |
| 0 (this device) | K152868 | ExpressBraid Graft Manipulation | Biomet Manufacturing Corp | 2016 | — |
| +1 | K163651 | ExpressBraid Graft Manipulation | Biomet Manufacturing Corp | 2017 | — |
| +1 | K160854 | MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture | Biomet Manafacturing Corp. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 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? (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 |
|---|---|---|---|
| * | K122374 | Arthrex Suture (Uhmwpe)Summary page 4…cal Suture (21 CFR 878.5000) Legally marketed devices to which substantial equivalence is claimed: Predicate Device: x Arthrex Suture - K122374 Reference Devices: x Teleflex Force Fiber - K033654/K040472 Device Description The ExpressBraid Graft Manipulation device co… | 2012 |
| † | K033654 | Force Fiber | 2004 |
| † | K040472 | Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture | 2004 |
What descends from it? (2)
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 26 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- 4 of the 32 ancestors have a recall of any class.
- Of its descendants, K163651 (Biomet Manufacturing Corp, 2017) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K122374.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
The ExpressBraid Graft Manipulation is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152868: ExpressBraid Graft Manipulation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152868
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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