510(k) · Cleared
Recalled · Class II · 2016Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyrx Pharma, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Jan 16, 2008 as substantially equivalent to K053656 (Tyrx Pharma, Inc., 2006) and 1 other predicate after a 463-day review. Its family tree reaches back 7 generations to 1993. 17 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 16, 2008
- Review
- 463 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 7 generations to K931386 (1993). 18 ancestors in all, the oldest K922916 (1992). 17 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 6 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 5 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 4 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 3 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 2 generations backK042592 Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone…American Medical Systems, Inc. · 2004
- 1 generation backK053656 Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006
- This deviceK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008
- Descendant · cites it directly · 14 of its ownK130943 Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK131007 Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013
- Descendant · 2 generations on · 5 of its ownK132699 Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013
- Descendant · 2 generations on · 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
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013 · cites it directly14descendants
- K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013 · cites it directly6descendants
- K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013 · 2 generations on5descendants
- K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2014 · 2 generations on4descendants
- K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −6 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −5 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −4 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −3 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −2 | K042592 | Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304 | American Medical Systems, Inc. | 2004 | — |
| −1 | K053656 | Tyrx Antimicrobial Mesh | Tyrx Pharma, Inc. | 2006 | — |
| 0 (this device) | K063091 | Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 | Tyrx Pharma, Inc. | 2008 | — |
| +1 | K130943 | Aigis RX R PM/ Aigis RX R Icd | Tyrx, Inc. | 2013 | — |
| +1 | K131007 | Aigis RX N Medium; Aigis RX N Large | Tyrx, Inc. | 2013 | — |
| +2 | K132699 | Aigis RX N (Medium), Aigis RX N (Large) | Tyrx, Inc. | 2013 | — |
| +2 | K142611 | TYRX Neuro Absorbable Antibacterial Envelope | Medtronic Tyrx, Inc. | 2014 | — |
| +1 | K140306 | Cormatrix Protect Ecm Envelope | Cormatrix Cardiovascular, Inc. | 2014 | 2 |
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 |
|---|---|---|
| 2013 | 3 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K053656 | Tyrx Antimicrobial MeshSummary page 1…ymeric Mesh, Pacemaker Predicate Devices Name and 5 10(k) Numbers: * Bard Parsonnet Pacemaker Pouch (Listing Number 2212754) * Pivit AB (TyRx Antimicrobial Mesh) (K053656) * OrthoGuard AB Antimicrobial Sleeve (K012198) Device Description AJGISRX is a dual component (resorbable and non-resorbable… | 2006 |
| * | K012198 | Gibbons Sterile Trocar KitsSummary page 1…5 10(k) Numbers: * Bard Parsonnet Pacemaker Pouch (Listing Number 2212754) * Pivit AB (TyRx Antimicrobial Mesh) (K053656) * OrthoGuard AB Antimicrobial Sleeve (K012198) Device Description AJGISRX is a dual component (resorbable and non-resorbable), sterile prosthesis designed to hold a pacemaker… | 2001 |
| * | — | Bard Parsonnet Pacemaker Pouch Named without a submission number |
What descends from it? (17)
See all 173 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 29, 2016 | Class II | Z-2541-2016 | Process control | TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. |
| Jun 29, 2016 | Class II | Z-2539-2016 | Process control | TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. |
| Jun 29, 2016 | Class II | Z-2540-2016 | Process control | TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K130943 (Tyrx, Inc., 2013) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K053656.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 is intended to securely hold a pacemaker pulse generator or defibrillator in order to create a stable environment when implanted in the body. AIGISRx 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 the generator or defibrillator. This device is only intended to be used in conjunction with pacemakers and implantable defibrillators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063091: Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063091
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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