510(k) · Cleared
ClearedPoly-Tapes (Various Sizes and Woven Construction Variants)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xiros Plc · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Aug 28, 2001 after a 405-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 28, 2001
- Review
- 405 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK002172 Poly-Tapes (Various Sizes and Woven Construction Variants)Xiros Plc · 2001
- Descendant · cites it directly · 3 of its ownK060367 TenoligFournitures Hospitalieres Industrie · 2006
- Descendant · 2 generations on · 2 of its ownK080974 TLS Fixation SystemFournitures Hospitalieres Industrie · 2008
- Descendant · cites it directly · 0 of its ownK171680 Infinity-Lock 3, Infinity-Lock 5Xiros, Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK120740 Cols® Fixation SystemFournitures Hospitalieres Industrie · 2013
- Descendant · 3 generations on · 0 of its ownK113591 Cols PeekFournitures Hospitalieres Industrie · 2011
Most influential descendants
Showing 5 of 5 · See all- K060367TenoligFournitures Hospitalieres Industrie · 2006 · cites it directly3descendants
- K080974TLS Fixation SystemFournitures Hospitalieres Industrie · 2008 · 2 generations on2descendants
- K171680Infinity-Lock 3, Infinity-Lock 5Xiros, Ltd. · 2017 · cites it directly0descendants
- K120740Cols® Fixation SystemFournitures Hospitalieres Industrie · 2013 · 3 generations on0descendants
- K113591Cols PeekFournitures Hospitalieres Industrie · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002172 | Poly-Tapes (Various Sizes and Woven Construction Variants) | Xiros Plc | 2001 | — |
| +1 | K060367 | Tenolig | Fournitures Hospitalieres Industrie | 2006 | — |
| +2 | K080974 | TLS Fixation System | Fournitures Hospitalieres Industrie | 2008 | — |
| +1 | K171680 | Infinity-Lock 3, Infinity-Lock 5 | Xiros, Ltd. | 2017 | — |
| +3 | K120740 | Cols® Fixation System | Fournitures Hospitalieres Industrie | 2013 | — |
| +3 | K113591 | Cols Peek | Fournitures Hospitalieres Industrie | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K060367 (Fournitures Hospitalieres Industrie, 2006) has gone furthest, with 3 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.
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 | — |
https://510kreport.com/device/K002172 · printed Nov 3, 2026
Cite this page
510(k) Report. “K002172: Poly-Tapes (Various Sizes and Woven Construction Variants).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K002172
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026