510(k) · Cleared
ClearedPoly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xiros, Ltd. · FTL Mesh, Surgical, Polymeric
Cleared on Aug 26, 2022 as substantially equivalent to K112786 (Synovis Orthopedic and Woundcare, Inc., 2011) and 2 other predicates after a 226-day review. Its family tree reaches back 14 generations to 1993. 1 of the 131 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Aug 26, 2022
- Review
- 226 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K931386 (1993). 126 ancestors in all, the oldest K810428 (1981). 4 later devices descend from it, 3 citing it directly. 1 of the 131 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 10 generations between
- 3 generations backK080185 Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate…American Medical Systems, Inc. · 2008
- 2 generations backK090288 Orthadapt PRPegasus Biologics, Inc. · 2009
- 1 generation backK112786 Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011
- This deviceK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK251063 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025
- Descendant · cites it directly · 1 of its ownK261621 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026
- Descendant · 2 generations on · 0 of its ownK262729 TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026
- Descendant · cites it directly · 0 of its ownK230671 Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd. · 2023
Show all 14 generations
- Root · 14 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 13 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 12 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 11 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 10 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 9 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 8 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 7 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 6 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 5 generations backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
- 4 generations backK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
- 3 generations backK080185 Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate…American Medical Systems, Inc. · 2008
- 2 generations backK090288 Orthadapt PRPegasus Biologics, Inc. · 2009
- 1 generation backK112786 Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011
- This deviceK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
Class I recalls in this family
- K963967 Glycar Pericardial Patch4 generations back · 1997
Most influential descendants
Showing 4 of 4 · See all- K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025 · cites it directly2descendants
- K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026 · cites it directly1descendant
- K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026 · 2 generations on0descendants
- K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −13 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −12 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −11 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −10 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −9 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −8 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −7 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −6 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −5 | K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | 2005 | 1 |
| −4 | K051485 | Ams Pelvic Floor Repair System | American Medical Systems, Inc. | 2005 | — |
| −3 | K080185 | Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen… | American Medical Systems, Inc. | 2008 | — |
| −2 | K090288 | Orthadapt PR | Pegasus Biologics, Inc. | 2009 | — |
| −1 | K112786 | Proseries Bioimplants-Proankle/Procuff | Synovis Orthopedic and Woundcare, Inc. | 2011 | — |
| 0 (this device) | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| +1 | K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025 | — |
| +1 | K261621 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026 | — |
| +2 | K262729 | TeKBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026 | — |
| +1 | K230671 | Pitch PaSoft Tissue Reinforcement Device | Xiros, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 2 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 8 | 0 |
| 1997 | 5 | 1 |
| 1998 | 10 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 11 | 0 |
| 2005 | 5 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
1 device in this family has a Class I recall. 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 K243315 ProGrip™ Self-Gripping Polypropylene Meshscore 14.4 · 10 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 |
|---|---|---|---|
| * | K112786 | Proseries Bioimplants-Proankle/ProcuffSummary page 4…ent device described in this submission is substantially equivalent to the following predicate devices: PRO series Bioimplants – PROcuff/PROankle (Formerly OrthAdapt) (K112786) FlexBand Plus (Formerly SPORTMesh)( K192112) Xylos® MacroPorous Surgical Mesh (K111584) ,QILQLW\/RFN 5HIHUHQFH'HYLFH.… | 2011 |
| * | K192112 | FlexBand PlusSummary page 4…bstantially equivalent to the following predicate devices: PRO series Bioimplants – PROcuff/PROankle (Formerly OrthAdapt) (K112786) FlexBand Plus (Formerly SPORTMesh)( K192112) Xylos® MacroPorous Surgical Mesh (K111584) ,QILQLW\/RFN 5HIHUHQFH'HYLFH. Device Description The Poly-Tape,QILQ… | 2019 |
| * | K111584 | Xylos Macro-Porous Surgical MeshSummary page 4…edicate devices: PRO series Bioimplants – PROcuff/PROankle (Formerly OrthAdapt) (K112786) FlexBand Plus (Formerly SPORTMesh)( K192112) Xylos® MacroPorous Surgical Mesh (K111584) ,QILQLW\/RFN 5HIHUHQFH'HYLFH. Device Description The Poly-Tape,QILQLW\/RFN6RIW7LVVXH5HLQIRUFHPHQWGHYLFH i… | 2011 |
| † | K171680 | Infinity-Lock 3, Infinity-Lock 5 | 2017 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K963967Glycar Pericardial PatchGlycar, Inc. · 1997 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 13 of the 126 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K251063 (Theramicro, 2025) has gone furthest, with 2 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. 2022, 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?
The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during soft tissue repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons . The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is not intended to replace normal body structure or provide the full…
Read the full statement (104 words)
The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during soft tissue repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons .
The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220091 · printed Nov 3, 2026
Cite this page
510(k) Report. “K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K220091
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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