510(k) · Cleared
ClearedAigis RX N (Medium), Aigis RX N (Large)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyrx, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Nov 26, 2013 as substantially equivalent to K131007 (Tyrx, Inc., 2013) after an 89-day review. Its family tree reaches back 9 generations to 1993. 5 later devices descend from it.
- Decided
- Nov 26, 2013
- Review
- 89 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931386 (1993). 20 ancestors in all, the oldest K922916 (1992). 5 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 5 generations between
- 3 generations backK053656 Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006
- 2 generations backK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
- 1 generation backK131007 Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013
- This deviceK132699 Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK142611 TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK150291 TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK180122 TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro…Medtronic, Inc. · 2018
- Descendant · 4 generations on · 0 of its ownK192636 TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro…Medtronic, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK152678 TYRX Neuro Antibacterial EnvelopeTyrx, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 8 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 7 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 6 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 5 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 4 generations backK042592 Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone…American Medical Systems, Inc. · 2004
- 3 generations backK053656 Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006
- 2 generations backK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
- 1 generation backK131007 Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013
- This deviceK132699 Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2014 · cites it directly4descendants
- K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2015 · 2 generations on3descendants
- K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable…Medtronic, Inc. · 2018 · 3 generations on1descendant
- K192636TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable…Medtronic, Inc. · 2020 · 4 generations on0descendants
- K152678TYRX Neuro Antibacterial EnvelopeTyrx, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −8 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −7 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −6 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −5 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −4 | K042592 | Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304 | American Medical Systems, Inc. | 2004 | — |
| −3 | K053656 | Tyrx Antimicrobial Mesh | Tyrx Pharma, Inc. | 2006 | — |
| −2 | K063091 | Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 | Tyrx Pharma, Inc. | 2008 | 3 |
| −1 | K131007 | Aigis RX N Medium; Aigis RX N Large | Tyrx, Inc. | 2013 | — |
| 0 (this device) | K132699 | Aigis RX N (Medium), Aigis RX N (Large) | Tyrx, Inc. | 2013 | — |
| +1 | K142611 | TYRX Neuro Absorbable Antibacterial Envelope | Medtronic Tyrx, Inc. | 2014 | — |
| +2 | K150291 | TYRX Neuro Absorbable Antibacterial Envelope | Medtronic Tyrx, Inc. | 2015 | — |
| +3 | K180122 | TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable… | Medtronic, Inc. | 2018 | — |
| +4 | K192636 | TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable… | Medtronic, Inc. | 2020 | — |
| +1 | K152678 | TYRX Neuro Antibacterial Envelope | Tyrx, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K131007 | Aigis RX N Medium; Aigis RX N LargeSummary page 2…lass 11 PROCODE: FTL Predicate Device Name and 510(k) Number: AIGISRx®'N (K131007) Device Description: AIGISRx\N is a dual component (resorbable and non-resorbable) sterile prosthesis designed to… | 2013 |
| † | K063091 | Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 | 2008 |
What descends from it? (5)
2 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?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K142611 (Medtronic Tyrx, Inc., 2014) has gone furthest, with 4 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. 2013, 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?
AIGISRx N is intended to hold a vagus nerve stimulator or spinal cord neuromodulator securely in order to create a stable environment when implanted in the body. AIGISRx N contains the antimicrobial agents rifampin and minocycline which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of a pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa, or spinal cord neuromodulatars implanted laterally to the body midline and slightly superior to the gluteal region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132699: Aigis RX N (Medium), Aigis RX N (Large).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132699
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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