510(k) · Cleared
ClearedTYRX Neuro Absorbable Antibacterial Envelope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Tyrx, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Dec 31, 2014 as substantially equivalent to K132699 (Tyrx, Inc., 2013) and 1 other predicate after a 106-day review. Its family tree reaches back 10 generations to 1993. 4 later devices descend from it.
- Decided
- Dec 31, 2014
- Review
- 106 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K931386 (1993). 22 ancestors in all, the oldest K922916 (1992). 4 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 6 generations between
- 3 generations backK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
- 2 generations backK131007 Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013
- 1 generation backK132699 Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013
- This deviceK142611 TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK150291 TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK180122 TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro…Medtronic, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK192636 TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro…Medtronic, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK152678 TYRX Neuro Antibacterial EnvelopeTyrx, Inc. · 2015
Show all 10 generations
- Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 9 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 8 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 7 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 6 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 5 generations backK042592 Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone…American Medical Systems, Inc. · 2004
- 4 generations backK053656 Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006
- 3 generations backK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
- 2 generations backK131007 Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013
- 1 generation backK132699 Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013
- This deviceK142611 TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2015 · cites it directly3descendants
- K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable…Medtronic, Inc. · 2018 · 2 generations on1descendant
- K192636TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable…Medtronic, Inc. · 2020 · 3 generations on0descendants
- K152678TYRX Neuro Antibacterial EnvelopeTyrx, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −9 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −8 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −7 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −6 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −5 | K042592 | Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304 | American Medical Systems, Inc. | 2004 | — |
| −4 | K053656 | Tyrx Antimicrobial Mesh | Tyrx Pharma, Inc. | 2006 | — |
| −3 | K063091 | Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 | Tyrx Pharma, Inc. | 2008 | 3 |
| −2 | K131007 | Aigis RX N Medium; Aigis RX N Large | Tyrx, Inc. | 2013 | — |
| −1 | K132699 | Aigis RX N (Medium), Aigis RX N (Large) | Tyrx, Inc. | 2013 | — |
| 0 (this device) | K142611 | TYRX Neuro Absorbable Antibacterial Envelope | Medtronic Tyrx, Inc. | 2014 | — |
| +1 | K150291 | TYRX Neuro Absorbable Antibacterial Envelope | Medtronic Tyrx, Inc. | 2015 | — |
| +2 | K180122 | TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable… | Medtronic, Inc. | 2018 | — |
| +3 | K192636 | TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable… | Medtronic, Inc. | 2020 | — |
| +2 | 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 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K132699 | Aigis RX N (Medium), Aigis RX N (Large)Summary page 5…Predicate Device Name and 510(k) Number AIGISRx N Antibacterial Envelope (K132699) (Primary Predicate)… | 2013 |
| * | K130943 | Aigis RX R PM/ Aigis RX R IcdSummary page 5…AIGISRx Resorbable Antibacterial Envelope (K130943) Device Description: TYRX TM Neuro Absorbable Antibacterial Envelope is a fully absorbable , dual component sterile device de… | 2013 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150291 | TYRX Neuro Absorbable Antibacterial Envelope | 2015 | 3 |
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 21 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K150291 (Medtronic Tyrx, Inc., 2015) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K132699.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
TYRXTM Neuro Absorbable Antibacterial Envelope 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. TYRXTM Neuro Absorbable Antibacterial Envelope 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…
Read the full statement (112 words)
TYRXTM Neuro Absorbable Antibacterial Envelope 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.
TYRXTM Neuro Absorbable Antibacterial Envelope 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 neuromodulators implanted laterally to the body midline and slightly superior to the gluteal region.
TYRXTM Neuro Absorbable Antibacterial Envelope is intended for single patient, one-time use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142611: TYRX Neuro Absorbable Antibacterial Envelope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142611
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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