510(k) · Cleared
ClearedTyrx Antimicrobial Mesh
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 Jul 14, 2006 as substantially equivalent to K052864 (Tyrx Pharma, Inc., 2005) and 2 other predicates after a 196-day review. Its family tree reaches back 6 generations to 1993. 24 later devices descend from it.
- Decided
- Jul 14, 2006
- Review
- 196 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K931386 (1993). 16 ancestors in all, the oldest K922916 (1992). 24 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 5 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 4 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 3 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 2 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 1 generation backK042592 Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone…American Medical Systems, Inc. · 2004
- This deviceK053656 Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006
- Descendant · cites it directly · 17 of its ownK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 14 of its ownK130943 Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK131007 Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013
- Descendant · 3 generations on · 5 of its ownK132699 Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK093524 Pivit a/B ST and Pivit a/B ST-RTyrx, Inc. · 2010
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · cites it directly17descendants
- K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013 · 2 generations on14descendants
- K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013 · 2 generations on6descendants
- K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013 · 3 generations on5descendants
- K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc. · 2010 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −5 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −4 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −3 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −2 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −1 | K042592 | Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304 | American Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K053656 | Tyrx Antimicrobial Mesh | Tyrx Pharma, Inc. | 2006 | — |
| +1 | K063091 | Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 | Tyrx Pharma, Inc. | 2008 | 3 |
| +2 | K130943 | Aigis RX R PM/ Aigis RX R Icd | Tyrx, Inc. | 2013 | — |
| +2 | K131007 | Aigis RX N Medium; Aigis RX N Large | Tyrx, Inc. | 2013 | — |
| +3 | K132699 | Aigis RX N (Medium), Aigis RX N (Large) | Tyrx, Inc. | 2013 | — |
| +1 | K093524 | Pivit a/B ST and Pivit a/B ST-R | Tyrx, Inc. | 2010 | — |
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 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052864 | Tyrx Surgical Mesh, Model SMPC-0501Summary page 1…etary Name: PivitABTM Device CommonlClassification Name: Polymeric Surgical Mesh Predicate Devices Name and 5 10(k) Numbers: TyRx Surgical Mesh (K052864) AMS InteMeshTM Silicone-Coated Sling and Surgical Mesh with JnibiZone TM (K042592) Spectrum(Rt Central Venous Catheter w… | 2005 |
| * | K042592 | Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304Summary page 1…ical Mesh Predicate Devices Name and 5 10(k) Numbers: TyRx Surgical Mesh (K052864) AMS InteMeshTM Silicone-Coated Sling and Surgical Mesh with JnibiZone TM (K042592) Spectrum(Rt Central Venous Catheter with or without Hydrophilic Coating (K000343) GORE-TEX® DualMesh® PLUS Biomaterial (… | 2004 |
| Kept off the family tree | K000343 | FDA’s K000343 is Nac Y-Adp Our reading of the summary gave K000343, FDA’s number for Nac Y-Adp (The Kipp Group). Its FDA name has none of the distinctive words the summary uses for the device it names, “Spectrum Central Venous Catheter with or without Hydrophilic Coating”. Kept off the family tree. Summary page 1…2864) AMS InteMeshTM Silicone-Coated Sling and Surgical Mesh with JnibiZone TM (K042592) Spectrum(Rt Central Venous Catheter with or without Hydrophilic Coating (K000343) GORE-TEX® DualMesh® PLUS Biomaterial (I mm and 2 mm) (K000185) Device Description: 4 ~~~~PivitABTM is dual component… | 2000 |
| * | K000185 | Gore-Tex Dualmesh Plus Biomaterial (1 MM & 2MM)Summary page 1…th JnibiZone TM (K042592) Spectrum(Rt Central Venous Catheter with or without Hydrophilic Coating (K000343) GORE-TEX® DualMesh® PLUS Biomaterial (I mm and 2 mm) (K000185) Device Description: 4 ~~~~PivitABTM is dual component (resorbable and non-resorbable), sterile prosthesis designed… | 2000 |
What descends from it? (24)
See all 243 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 13 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K063091 (Tyrx Pharma, Inc., 2008) has gone furthest, with 17 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.
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?
Is intended for the repair of hernias and other abdominal fascial deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surgical implantation. Examples of applications where PivitABTM may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053656: Tyrx Antimicrobial Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053656
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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