510(k) · Cleared
Recalled · Class II · 2026FlexBand; FlexPatch; FlexBand Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Life Sciences · OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Cleared on May 26, 2023 as substantially equivalent to K192112 (International Life Sciences, 2019) and 1 other predicate after a 109-day review. Its family tree reaches back 14 generations to 1993. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- May 26, 2023
- Review
- 109 days
- Class
- Class II
- Product code
- OWW
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 14 generations to K931386 (1993). 100 ancestors in all, the oldest K810428 (1981). 3 later devices descend from it, 2 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 deviceK230316 FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 2023
- Descendant · cites it directly · 1 of its ownK242187 BioBrace®Conmed Corporation · 2024
- Descendant · cites it directly · 0 of its ownK260317 Artelon Convenience KitsInternational Life Sciences · 2026
- Descendant · 2 generations on · 0 of its ownK252946 BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 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 deviceK230316 FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 2023
Most influential descendants
Showing 3 of 3 · See allView 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) | K230316 | FlexBand; FlexPatch; FlexBand Plus | International Life Sciences | 2023 | — |
| +1 | K242187 | BioBrace® | Conmed Corporation | 2024 | — |
| +1 | K260317 | Artelon Convenience Kits | International Life Sciences | 2026 | — |
| +2 | K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | 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 | 10 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 OWW? 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 OWW device
- #1 K241906 BioBrace® Reinforced Implantscore 17.1 · 12 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 |
|---|---|---|---|
| * | K192112 | FlexBand PlusSummary page 4…atch® / FlexBand® Plus devices described in this submission are substantially equivalent to the following predicate devices: The FlexBand® / FlexPatch® / FlexBand® Plus (K192112) BioBridge™ Collagen Matrix (K151083) IV. Device Description The FlexBand® / FlexPatch® / FlexBand® Plus products are k… | 2019 |
| * | K151083 | BioBridge Collagen MatrixSummary page 4…bed in this submission are substantially equivalent to the following predicate devices: The FlexBand® / FlexPatch® / FlexBand® Plus (K192112) BioBridge™ Collagen Matrix (K151083) IV. Device Description The FlexBand® / FlexPatch® / FlexBand® Plus products are knitted mesh made from ARTELON® fibers… | 2016 |
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| Feb 6, 2026 | Class II | Z-1555-2026 | Process control | Augmentation devices failed bacterial endotoxin testing. |
| Feb 6, 2026 | Class II | Z-1554-2026 | Process control | Augmentation devices failed bacterial endotoxin testing. |
| Feb 6, 2026 | Class II | Z-1556-2026 | Process control | Augmentation devices failed bacterial endotoxin testing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 8 of the 100 ancestors have a recall of any class.
- Of its descendants, K242187 (Conmed Corporation, 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K192112.
How does its category compare?
All OWW devicesOWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OWW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWW
81in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWW
No recall names OWW since 2007.
Adverse event reports per year · OWW
2in 2025
MAUDE reports naming product code OWW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 3 | 81 | 0 | 0 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
FlexBand®, FlexPatch®, and FlexBand® Plus are intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. FlexBand®, FlexPatch®, and FlexBand® Plus are also 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 tendons, medial collateral ligament, lateral…
Read the full statement (170 words)
FlexBand®, FlexPatch®, and FlexBand® Plus are intended for use in surgical procedures for reinforcement of soft tissue where weakness exists.
FlexBand®, FlexPatch®, and FlexBand® Plus are also 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 tendons, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments.
FlexBand®, FlexPatch®, and FlexBand® Plus is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendons, 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 tendon repair. The products reinforce soft tissue and provides a degradable scaffold that is incorporated into the patient’s own tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230316 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230316: FlexBand; FlexPatch; FlexBand Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230316
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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