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. · QUW Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
Cleared on Dec 27, 2022 as substantially equivalent to K151083 (Fibralign Corporation, 2016) after a 90-day review. Its family tree reaches back 14 generations to 1993. 4 later devices descend from it.
- Decided
- Dec 27, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- QUW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K931386 (1993). 93 ancestors in all, the oldest K810428 (1981). 4 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 10 generations between
- 3 generations backK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
- 2 generations backK131143 Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013
- 1 generation backK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
- This deviceK222978 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 ownK242237 Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited · 2025
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 backK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
- 3 generations backK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
- 2 generations backK131143 Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013
- 1 generation backK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
- This deviceK222978 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
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
- K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited · 2025 · 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 | K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal… | American Medical Systems, Inc. | 2008 | — |
| −3 | K120019 | Collagen Ribbon | Wrightmedicaltechnologyinc | 2012 | — |
| −2 | K131143 | Trellis Collagen Ribbon | Wrightmedicaltechnologyinc | 2013 | — |
| −1 | K151083 | BioBridge Collagen Matrix | Fibralign Corporation | 2016 | — |
| 0 (this device) | K222978 | 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 | K242237 | Jewel Soft Tissue Reinforcement Device (102-6005) | Xiros Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 8 | 0 |
| 1999 | 2 | 0 |
| 2000 | 9 | 0 |
| 2001 | 5 | 0 |
| 2002 | 9 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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.
Planning a device in QUW? 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 QUW device
- #1 K251063 TekBrace Solo Soft Tissue Reinforcement Devicescore 19.6 · 15 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 |
|---|---|---|---|
| * | K151083 | BioBridge Collagen MatrixSummary page 4…/Infinity Lock Soft Tissue Reinforcement Device described in this submission is substantially equivalent to the following predicate devices: BioBridge™ Collagen Matrix (K151083) Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K220091) – Reference Device Device Description The Poly-Tape/Infinit… | 2016 |
| † | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | 2022 |
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? (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 29 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 8 of the 93 ancestors have a recall of any class.
- Of its descendants, K251063 (Theramicro, 2025) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K151083.
How does its category compare?
All QUW devicesQUW Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QUW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QUW
Too few QUW 510(k)s in any year since 2007 to give a median.
Recalls per year · QUW
No recall names QUW since 2007.
Adverse event reports per year · QUW
No MAUDE report names QUW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 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 tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or…
Read the full statement (136 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 tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments.
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, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222978 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222978: 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 5, 2026. https://510kreport.com/device/K222978
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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