510(k) · Cleared
ClearedNeotract Anchor System Model: Ref 11208
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 Jul 15, 2010 as substantially equivalent to K073651 (Neotract, Inc., 2008) and 2 other predicates after a 72-day review. Its family tree reaches back 6 generations to 1997. 1 later device descends from it.
- Decided
- Jul 15, 2010
- Review
- 72 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K972679 (1997). 15 ancestors in all, the oldest K934738 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
- 5 generations backK980022 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1998
- 4 generations backK994290 Bard Endoscopic Suturing SystemC.R. Bard, Inc. · 2000
- 3 generations backK062875 Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2007
- 2 generations backK071651 Egs Serosafuse Implantable Fasteners, Associated Delivery Devices…Endogastric Solutions, Inc. · 2007
- 1 generation backK073644 Endogastric Solutions Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2008
- This deviceK101252 Neotract Anchor System Model: Ref 11208Neotract, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK102028 Neotract Anchor System Model TAS400Neotract, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K102028Neotract Anchor System Model TAS400Neotract, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K972679 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −5 | K980022 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −4 | K994290 | Bard Endoscopic Suturing System | C.R. Bard, Inc. | 2000 | — |
| −3 | K062875 | Endogastric Stomaphyx Device and Accessories | Endogastric Solutions, Inc. | 2007 | — |
| −2 | K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and… | Endogastric Solutions, Inc. | 2007 | — |
| −1 | K073644 | Endogastric Solutions Stomaphyx Device and Accessories | Endogastric Solutions, Inc. | 2008 | — |
| 0 (this device) | K101252 | Neotract Anchor System Model: Ref 11208 | Neotract, Inc. | 2010 | — |
| +1 | K102028 | Neotract Anchor System Model TAS400 | Neotract, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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? (3)
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 |
|---|---|---|---|
| * | K073651 | Neotract Anchor SystemSummary page 1…is intended for the approximation of tissue in open surgical procedures. Predicate Devices NeoTract Anchor System K073651 Manufactured by NeoTract, Inc. Nonabsorbable Surgical Suture K021019 Manufactured… | 2008 |
| * | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester SutureSummary page 1…K073651 Manufactured by NeoTract, Inc. Nonabsorbable Surgical Suture K021019 Manufactured by Genzyme Corporation StomaphyX Delivery Device, Fasteners and Accessories K073644 Manufac… | 2002 |
| * | K073644 | Endogastric Solutions Stomaphyx Device and AccessoriesSummary page 1…K021019 Manufactured by Genzyme Corporation StomaphyX Delivery Device, Fasteners and Accessories K073644 Manufactured by EndoGastric Solutions, Inc. Device Description The Modified NecTract Anchor System is used for the approximation… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102028 | Neotract Anchor System Model TAS400 | 2010 | 0 |
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 13 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K102028 (Neotract, Inc., 2010) has gone furthest, with 0 descendants 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. 2010, 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 Modified NeoTract Anchor System is intended for the approximation of tissue in open surgical procedures.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K101252 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101252: Neotract Anchor System Model: Ref 11208.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101252
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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