510(k) · Cleared
ClearedSoftform Facial Implant
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 Nov 24, 1997 after a 73-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 96 later devices descend from it.
- Decided
- Nov 24, 1997
- Review
- 73 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
96 later devices descend from it, 1 citing it directly.
- This deviceK973462 Softform Facial ImplantTissue Technologies, Inc. · 1997
- 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) | K973462 | Softform Facial Implant | Tissue Technologies, Inc. | 1997 | — |
| +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), 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 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’s file for it is a 510(k) statement, which names no predicate.
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 | — |
What is it indicated for?
For Plastic and Reconstructive Surgery*
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973462 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973462: Softform Facial Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973462
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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