510(k) · Cleared
ClearedFreedom Inguinal Hernia Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insightra Medical · FTL Mesh, Surgical, Polymeric
Cleared on Aug 23, 2012 as substantially equivalent to K922916 (C.R. Bard, Inc., 1992) and 1 other predicate after a 266-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Aug 23, 2012
- Review
- 266 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922916 (1992). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K140967Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended DiskInsightra Medical · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922916 | Bard Marlex Mesh Dart | C.R. Bard, Inc. | 1992 | — |
| 0 (this device) | K113552 | Freedom Inguinal Hernia Implant | Insightra Medical | 2012 | — |
| +1 | K140967 | Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended Disk | Insightra Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K922916 | Bard Marlex Mesh DartSummary page 1…Common Name: Surgical mesh Classification Name: Surgical polymeric mesh (21 CFR 878.3300) Product Code: FTL c. Predicate Devices Bard Perfix Plug (K922916) Ethicon Prolene Hernia System (K984220) d. Device Description The Freedom Inguinal Hernia Implant is used to plug or patch a her… | 1992 |
| * | K984220 | Modification of Prolene (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical…Summary page 1…ssification Name: Surgical polymeric mesh (21 CFR 878.3300) Product Code: FTL c. Predicate Devices Bard Perfix Plug (K922916) Ethicon Prolene Hernia System (K984220) d. Device Description The Freedom Inguinal Hernia Implant is used to plug or patch a hernia opening. The implant is wholly manuf… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140967 | Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended Disk | 2014 | 0 |
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. 2012, this device’s year, is highlighted.
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 Freedom Inguinal Hernia Implant is intended to be implanted to reinforce soft tissues where weakness for open repair of inguinal hernias exists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113552: Freedom Inguinal Hernia Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113552
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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