510(k) · Cleared
ClearedAtrium Medical Corporation Advanta Ptfe Facial Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrium Medical Corp. · FTL Mesh, Surgical, Polymeric
Cleared on Jan 27, 2000 after a 142-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 94 later devices descend from it.
- Decided
- Jan 27, 2000
- Review
- 142 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
94 later devices descend from it, 4 citing it directly.
- This deviceK992991 Atrium Medical Corporation Advanta Ptfe Facial ImplantAtrium Medical Corp. · 2000
- Descendant · cites it directly · 93 of its ownK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004
- Descendant · 2 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
- Descendant · 3 generations on · 14 of its ownK082176 LTM-BPS Surgical MeshLifecell Corp. · 2008
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K034039Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004 · cites it directly93descendants
- K070560LRTM Surgical MeshLifecell Corp. · 2007 · 2 generations on50descendants
- K060829CosmatrixTei Biosciences, Inc. · 2006 · 2 generations on18descendants
- K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · 3 generations on17descendants
- K082176LTM-BPS Surgical MeshLifecell Corp. · 2008 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992991 | Atrium Medical Corporation Advanta Ptfe Facial Implant | Atrium Medical Corp. | 2000 | — |
| +1 | K034039 | Sis Plastic Surgery Matrix | Cook Biotech, Inc. | 2004 | — |
| +2 | 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 |
| +3 | K082176 | LTM-BPS Surgical Mesh | Lifecell Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 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? (94)
See all 944 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, K034039 (Cook Biotech, Inc., 2004) has gone furthest, with 93 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?
The Atrium Advanta™ PTFE Facial Implant is intended for use in Facial 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/K992991 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992991: Atrium Medical Corporation Advanta Ptfe Facial Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992991
Report an extraction error
Are you the manufacturer?
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