510(k) · Cleared
ClearedAceConnex Pre-Sutured Fascia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allosource · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Jun 27, 2023 as substantially equivalent to K041553 (Arthrex, Inc., 2004) after a 643-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Jun 27, 2023
- Review
- 643 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K990088 (1999). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- 4 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
- 3 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
- 2 generations backK032245 Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex…Arthrex, Inc. · 2004
- 1 generation backK041553 Arthrex Suture Grafting KitArthrex, Inc. · 2004
- This deviceK213046 AceConnex Pre-Sutured FasciaAllosource · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990088 | Synthofil Nonabsorbable Pet Surgical Suture | Aesculap, Inc. | 1999 | — |
| −4 | K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201 | Arthrex, Inc. | 2001 | — |
| −3 | K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex, Inc. | 2002 | — |
| −2 | K032245 | Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape… | Arthrex, Inc. | 2004 | — |
| −1 | K041553 | Arthrex Suture Grafting Kit | Arthrex, Inc. | 2004 | — |
| 0 (this device) | K213046 | AceConnex Pre-Sutured Fascia | Allosource | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2001 | 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 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 |
|---|---|---|---|
| * | K041553 | Arthrex Suture Grafting KitSummary page 4…olyethylene 21 CFR 878.5000 GAT Predicate Device: Arthrex Suture Grafting Kit 510(k) # K041553 Reference Devices: ReConnex™ Pre-Sutured Tendon 510(k) # K170957 Force… | 2004 |
| † | K170957 | ReConnex Pre-Sutured Tendon | 2018 |
| † | K063778 | Force Fiber Polyethylene Nonabsorbable Suture | 2007 |
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 24 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 9 other devices also cite its predicate K041553.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 AceConnex™ Pre-Sutured Fascia is intended for use as a component in soft tissue surgical procedures where constructs including those with allograft tissues are used for reconstruction, replacement, or augmentation of the hip labrum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213046: AceConnex Pre-Sutured Fascia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213046
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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