510(k) · Cleared
ClearedNeotract Anchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neotract, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Feb 1, 2008 as substantially equivalent to K061700 (Neotract, Inc., 2006) after a 37-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Feb 1, 2008
- Review
- 37 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003522 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003522 SaluteOnux Medical, Inc. · 2001
- 1 generation backK061700 Neotract AnchorNeotract, Inc. · 2006
- This deviceK073651 Neotract Anchor SystemNeotract, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK101252 Neotract Anchor System Model: Ref 11208Neotract, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK102028 Neotract Anchor System Model TAS400Neotract, Inc. · 2010
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 |
|---|---|---|---|---|---|
| −2 | K003522 | Salute | Onux Medical, Inc. | 2001 | — |
| −1 | K061700 | Neotract Anchor | Neotract, Inc. | 2006 | — |
| 0 (this device) | K073651 | Neotract Anchor System | Neotract, Inc. | 2008 | — |
| +1 | K101252 | Neotract Anchor System Model: Ref 11208 | Neotract, Inc. | 2010 | — |
| +2 | K102028 | Neotract Anchor System Model TAS400 | Neotract, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 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 |
|---|---|---|---|
| * | K061700 | Neotract AnchorSummary page 2…PremarketNotification Comparison to Predicate Device The NeoTract Anchor System is substantially equivalent to the predicate device, NeoTract Anchor, K061700, in Indications for Use, Class, Principal Operator, Use Location, Operating Principle, Design, How Shipped, Reuse, and Sterilizat… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101252 | Neotract Anchor System Model: Ref 11208 | 2010 | 1 |
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 7 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101252 (Neotract, Inc., 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 NeoTract Anchor System is intended for the approximation of soft tissue in open surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073651: Neotract Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073651
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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