510(k) · Cleared
ClearedImmix Thin Film, Models: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteobiologics, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Mar 14, 2003 as substantially equivalent to K012025 (Macropore Biosurgery, Inc., 2001) after an 84-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Mar 14, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012025 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK012025 Macropore Surgiwrap (TS)Macropore Biosurgery, Inc. · 2001
- This deviceK024199 Immix Thin Film, Models: PSS-004-S, PSS-004-SP, PSS-004-M…Osteobiologics, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK082079 Regen Collagen Scaffold (CS)Regen Biologics, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK170364 Collagen Meniscus Implant XLIvy Sports Medicine, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK242302 RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012025 | Macropore Surgiwrap (TS) | Macropore Biosurgery, Inc. | 2001 | — |
| 0 (this device) | K024199 | Immix Thin Film, Models: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP… | Osteobiologics, Inc. | 2003 | — |
| +1 | K082079 | Regen Collagen Scaffold (CS) | Regen Biologics, Inc. | 2008 | — |
| +2 | K170364 | Collagen Meniscus Implant XL | Ivy Sports Medicine, LLC | 2017 | — |
| +3 | K242302 | RejuvaKnee™ Collagen Meniscus Implant | Collagen Matrix, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
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 |
|---|---|---|---|
| * | K012025 | Macropore Surgiwrap (TS) | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082079 | Regen Collagen Scaffold (CS) | 2008 | 2 |
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?
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 IMMIXTMThin Film is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024199: Immix Thin Film, Models: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024199
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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