510(k) · Cleared
ClearedArtelon Convenience Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Life Sciences · QWJ Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
Cleared on Apr 9, 2026 as substantially equivalent to K230316 (International Life Sciences, 2023) and 1 other predicate after a 69-day review. Its family tree reaches back 15 generations to 1993.
- Decided
- Apr 9, 2026
- Review
- 69 days
- Class
- Class II
- Product code
- QWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K931386 (1993). 117 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 15 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 11 generations between
- 3 generations backK131143 Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013
- 2 generations backK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
- 1 generation backK230316 FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 2023 · Recalled
- This deviceK260317 Artelon Convenience KitsInternational Life Sciences · 2026
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 backK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
- 4 generations backK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
- 3 generations backK131143 Trellis Collagen RibbonWrightmedicaltechnologyinc · 2013
- 2 generations backK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
- 1 generation backK230316 FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 2023 · Recalled
- This deviceK260317 Artelon Convenience KitsInternational Life Sciences · 2026
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 | K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal… | American Medical Systems, Inc. | 2008 | — |
| −4 | K120019 | Collagen Ribbon | Wrightmedicaltechnologyinc | 2012 | — |
| −3 | K131143 | Trellis Collagen Ribbon | Wrightmedicaltechnologyinc | 2013 | — |
| −2 | K151083 | BioBridge Collagen Matrix | Fibralign Corporation | 2016 | — |
| −1 | K230316 | FlexBand; FlexPatch; FlexBand Plus | International Life Sciences | 2023 | 3 |
| 0 (this device) | K260317 | Artelon Convenience Kits | International Life Sciences | 2026 | — |
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 | 9 | 0 |
| 1997 | 5 | 0 |
| 1998 | 9 | 0 |
| 1999 | 2 | 0 |
| 2000 | 10 | 0 |
| 2001 | 6 | 0 |
| 2002 | 10 | 0 |
| 2003 | 6 | 0 |
| 2004 | 8 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 QWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K230316 | FlexBand; FlexPatch; FlexBand PlusSummary page 5…WJ, OWW, MBI (a)(3). Primary Predicate Device(s): FlexBand, FlexPatch, and FlexBand Plus (K230316) and ATL Anchors (K200503) (a)(4). Device Descrip on The subject device, Artelon convenience kits, contains implants an… | 2023 |
| * | K200503 | ATL AnchorsSummary page 5…ary Predicate Device(s): FlexBand, FlexPatch, and FlexBand Plus (K230316) and ATL Anchors (K200503) (a)(4). Device Descrip on The subject device, Artelon convenience kits, contains implants and instrumenta on for surgi… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 14 of the 117 ancestors have a recall of any class.
- 1 other device also cites its predicate K230316.
How does its category compare?
All QWJ devicesQWJ Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QWJ
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QWJ
Too few QWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QWJ
No recall names QWJ since 2007.
Adverse event reports per year · QWJ
No MAUDE report names QWJ 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 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 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 (285 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 provide a degradable scaffold that is incorporated into the patient's own tissue.
The Twist and FlexBand Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
• Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, llliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
• Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
• Hip: Acetabular labral repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260317: Artelon Convenience Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260317
Report an extraction error
Are you the manufacturer?
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