510(k) · Cleared
ClearedAigis RX R PM/ Aigis RX R Icd
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 May 20, 2013 as substantially equivalent to K063091 (Tyrx Pharma, Inc., 2008) after a 46-day review. Its family tree reaches back 8 generations to 1993. 14 later devices descend from it.
- Decided
- May 20, 2013
- Review
- 46 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K931386 (1993). 19 ancestors in all, the oldest K922916 (1992). 14 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 7 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 6 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 5 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 4 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 3 generations backK042592 Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone…American Medical Systems, Inc. · 2004
- 2 generations backK053656 Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006
- 1 generation backK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
- This deviceK130943 Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK142611 TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK140306 Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · Recalled
- Descendant · cites it directly · 3 of its ownK180030 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable…Medtronic, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 3 of its ownK150291 TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2015
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2014 · cites it directly4descendants
- K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · cites it directly4descendants
- K180030TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc. · 2018 · cites it directly3descendants
- K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2017 · 2 generations on3descendants
- K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2015 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −7 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −6 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −5 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −4 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −3 | K042592 | Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304 | American Medical Systems, Inc. | 2004 | — |
| −2 | K053656 | Tyrx Antimicrobial Mesh | Tyrx Pharma, Inc. | 2006 | — |
| −1 | K063091 | Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 | Tyrx Pharma, Inc. | 2008 | 3 |
| 0 (this device) | K130943 | Aigis RX R PM/ Aigis RX R Icd | Tyrx, Inc. | 2013 | — |
| +1 | K142611 | TYRX Neuro Absorbable Antibacterial Envelope | Medtronic Tyrx, Inc. | 2014 | — |
| +1 | K140306 | Cormatrix Protect Ecm Envelope | Cormatrix Cardiovascular, Inc. | 2014 | 2 |
| +1 | K180030 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial… | Medtronic, Inc. | 2018 | — |
| +2 | K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope… | Aziyo Biologics, Inc. | 2017 | 1 |
| +2 | K150291 | TYRX Neuro Absorbable Antibacterial Envelope | Medtronic 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 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K063091 | Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Summary page 1…ical Mesh, Class 11 Classification Name: Procode: FTL Predicate Devices Names and 510(k) Numbers: AIGISRX®( K063091 Device Description: AIGISRx® R (ARMIS R) is a fully resorbable, dual component sterile prosthesis designed to hold and stabili… | 2008 |
What descends from it? (14)
See all 143 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 2.7 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K142611 (Medtronic Tyrx, Inc., 2014) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K063091.
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® R is intended to hold a pacemaker pulse generator or defibrillator securely in order to create a stable environment when implanted in the body. AIGISRx® R contains the antimicrobial agents rifampin and minocycline which have been shown to reduce infection in in vivo models of bacterial challenge following surgical implantation of the generator or defibrillator. This device is only intended to be used in conjunction with pacemakers and implantable defibrillators.
AIGISRx® R is intended for single patient, one-time use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130943: Aigis RX R PM/ Aigis RX R Icd.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130943
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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