510(k) · Cleared
ClearedReConnex Pre-Sutured Tendon
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 Mar 20, 2018 as substantially equivalent to K041553 (Arthrex, Inc., 2004) after a 354-day review. Its family tree reaches back 5 generations to 1999. 3 later devices descend from it.
- Decided
- Mar 20, 2018
- Review
- 354 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. 3 later devices descend from it, 2 citing it directly.
- 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 deviceK170957 ReConnex Pre-Sutured TendonAllosource · 2018
- Descendant · cites it directly · 2 of its ownK181633 MTF Pre-Sutured TendonMusculoskeletal Transplant Foundation · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK230036 Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon…Rti Surgical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK253145 Pre-Sutured TendonRti Surgical, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K181633MTF Pre-Sutured TendonMusculoskeletal Transplant Foundation · 2019 · cites it directly2descendants
- K230036Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple…Rti Surgical, Inc. · 2023 · cites it directly1descendant
- K253145Pre-Sutured TendonRti Surgical, Inc. · 2025 · 2 generations on0descendants
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) | K170957 | ReConnex Pre-Sutured Tendon | Allosource | 2018 | — |
| +1 | K181633 | MTF Pre-Sutured Tendon | Musculoskeletal Transplant Foundation | 2019 | 1 |
| +1 | K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC /… | Rti Surgical, Inc. | 2023 | — |
| +2 | K253145 | Pre-Sutured Tendon | Rti Surgical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 1 | 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 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…rgical suture (21 CFR 878.5000) GAT Predicate Device: Arthrex Suture Grafting Kit 510(k) # K041553 Reference Device: Force Fiber UHWMPE Non-absorbable Surgical Suture 510(k) # K092533 This 510(k)… | 2004 |
| † | K092533 | Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures | 2009 |
What descends from it? (3)
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 19 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.
- Of its descendants, K181633 (Musculoskeletal Transplant Foundation, 2019) has gone furthest, with 2 descendants of its own.
- 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. 2018, 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?
Pre-sutured allograft tendons are intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170957: ReConnex Pre-Sutured Tendon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170957
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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