510(k) · Cleared
ClearedPitch PaSoft 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 May 31, 2023 as substantially equivalent to K220091 (Xiros, Ltd., 2022) and 1 other predicate after an 82-day review. Its family tree reaches back 15 generations to 1993. 1 of the 128 devices in its family, counting itself, has a Class I recall.
- Decided
- May 31, 2023
- Review
- 82 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K931386 (1993). 127 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet. 1 of the 128 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 11 generations between
- 3 generations backK090288 Orthadapt PRPegasus Biologics, Inc. · 2009
- 2 generations backK112786 Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011
- 1 generation backK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- This deviceK230671 Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd. · 2023
Show all 15 generations
- Root · 15 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 14 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 13 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 12 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 11 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 10 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 9 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 8 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 7 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 6 generations backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
- 5 generations backK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
- 4 generations backK080185 Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate…American Medical Systems, Inc. · 2008
- 3 generations backK090288 Orthadapt PRPegasus Biologics, Inc. · 2009
- 2 generations backK112786 Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011
- 1 generation backK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- This deviceK230671 Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd. · 2023
Class I recalls in this family
- K963967 Glycar Pericardial Patch5 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −14 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −13 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −12 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −11 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −10 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −9 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −8 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −7 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −6 | K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | 2005 | 1 |
| −5 | K051485 | Ams Pelvic Floor Repair System | American Medical Systems, Inc. | 2005 | — |
| −4 | K080185 | Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen… | American Medical Systems, Inc. | 2008 | — |
| −3 | K090288 | Orthadapt PR | Pegasus Biologics, Inc. | 2009 | — |
| −2 | K112786 | Proseries Bioimplants-Proankle/Procuff | Synovis Orthopedic and Woundcare, Inc. | 2011 | — |
| −1 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| 0 (this device) | 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 |
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 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 |
|---|---|---|---|
| * | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceSummary page 4…y equivalent to the following: Predicate/Reference Device Information Primary predicate: Poly-Tape Soft Tissue Reinforcement Device Premarket Notification: K220091 Product Code: FTL,OWX Secondary predicate: FlexBand Plus (FlexBand/FlexPatch) Premarket Notificati… | 2022 |
| * | K192112 | FlexBand PlusSummary page 4…vice Premarket Notification: K220091 Product Code: FTL,OWX Secondary predicate: FlexBand Plus (FlexBand/FlexPatch) Premarket Notification: K192112 Product Code: FTL Reference device: Pitch-Patch Tissue Reinforcement Device Premarket Notificat… | 2019 |
| † | K211563 | Pitch-Patchs | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 13 of the 127 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K220091.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Pitch-Patch 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 repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons.
The Pitch -Patch 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230671: Pitch PaSoft Tissue Reinforcement Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230671
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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