510(k) · Cleared
ClearedPre-Sutured Tendon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rti Surgical, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Oct 22, 2025 as substantially equivalent to K230036 (Rti Surgical, Inc., 2023) after a 27-day review. Its family tree reaches back 8 generations to 1999.
- Decided
- Oct 22, 2025
- Review
- 27 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K990088 (1999). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- 7 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
- 6 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
- 5 generations backK032245 Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex…Arthrex, Inc. · 2004
- 4 generations backK041553 Arthrex Suture Grafting KitArthrex, Inc. · 2004
- 3 generations backK170957 ReConnex Pre-Sutured TendonAllosource · 2018
- 2 generations backK181633 MTF Pre-Sutured TendonMusculoskeletal Transplant Foundation · 2019 · Recalled
- 1 generation backK230036 Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon…Rti Surgical, Inc. · 2023
- This deviceK253145 Pre-Sutured TendonRti Surgical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K990088 | Synthofil Nonabsorbable Pet Surgical Suture | Aesculap, Inc. | 1999 | — |
| −7 | K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201 | Arthrex, Inc. | 2001 | — |
| −6 | K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex, Inc. | 2002 | — |
| −5 | K032245 | Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape… | Arthrex, Inc. | 2004 | — |
| −4 | K041553 | Arthrex Suture Grafting Kit | Arthrex, Inc. | 2004 | — |
| −3 | K170957 | ReConnex Pre-Sutured Tendon | Allosource | 2018 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple…Summary page 5…yethylene Regulation Number: 21 CFR 878.5000 Regulatory Class: Class II Product Code: GAT Panel: Orthopedic Legally Marketed K230036 - Pre-Sutured Tendon Predicate Device(s): Device Description: The Pre-Sutured Tendon is a donated human nonbone tendon pre-su… | 2023 |
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 26 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 15 ancestors have a recall of any class.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.
The Pre-Sutured Tendon is for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253145 · printed Nov 3, 2026
Cite this page
510(k) Report. “K253145: Pre-Sutured Tendon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K253145
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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