510(k) · Cleared
ClearedSoftform Soft Tissue Augmentation Tube with Insertion Tool Modifications for Strands and Suture Holes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tissue Technologies, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Jul 24, 2000 after a 17-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 96 later devices descend from it.
- Decided
- Jul 24, 2000
- Review
- 17 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
96 later devices descend from it, 1 citing it directly.
- This deviceK002071 Softform Soft Tissue Augmentation Tube with Insertion Tool…Tissue Technologies, Inc. · 2000
- Descendant · cites it directly · 95 of its ownK013625 PermacolTissue Science Laboratories, Plc · 2002
- Descendant · 2 generations on · 93 of its ownK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004
- Descendant · 3 generations on · 50 of its ownK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
- Descendant · 2 generations on · 18 of its ownK060829 CosmatrixTei Biosciences, Inc. · 2006
- Descendant · 3 generations on · 17 of its ownK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 96 · See all- K013625PermacolTissue Science Laboratories, Plc · 2002 · cites it directly95descendants
- K034039Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004 · 2 generations on93descendants
- K070560LRTM Surgical MeshLifecell Corp. · 2007 · 3 generations on50descendants
- K060829CosmatrixTei Biosciences, Inc. · 2006 · 2 generations on18descendants
- K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002071 | Softform Soft Tissue Augmentation Tube with Insertion Tool Modifications for… | Tissue Technologies, Inc. | 2000 | — |
| +1 | K013625 | Permacol | Tissue Science Laboratories, Plc | 2002 | — |
| +2 | K034039 | Sis Plastic Surgery Matrix | Cook Biotech, Inc. | 2004 | — |
| +3 | K070560 | LRTM Surgical Mesh | Lifecell Corp. | 2007 | 2 |
| +2 | K060829 | Cosmatrix | Tei Biosciences, Inc. | 2006 | — |
| +3 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 10 | 0 |
| 2017 | 8 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 10 | 0 |
| 2026 | 3 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (96)
See all 961 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013625 | Permacol | 2002 | 95 |
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, K013625 (Tissue Science Laboratories, Plc, 2002) has gone furthest, with 95 descendants of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K002071 · printed Nov 4, 2026
Cite this page
510(k) Report. “K002071: Softform Soft Tissue Augmentation Tube with Insertion Tool Modifications for Strands and Suture Holes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002071
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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