510(k) · Cleared
ClearedSuturePatch Tissue Reinforcement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · OWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
Cleared on May 29, 2025 as substantially equivalent to K070961 (Biomerix Corporation, 2008) and 2 other predicates after a 202-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- May 29, 2025
- Review
- 202 days
- Class
- Class II
- Product code
- OWX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K921895 (1992). 89 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations between
- 3 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 2 generations backK052830 SportmeshArtimplant AB · 2006
- 1 generation backK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
- This deviceK243480 SuturePatch Tissue ReinforcementArthrex, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 8 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 7 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 6 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 5 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 4 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 3 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 2 generations backK052830 SportmeshArtimplant AB · 2006
- 1 generation backK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
- This deviceK243480 SuturePatch Tissue ReinforcementArthrex, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −8 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −7 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −6 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −5 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −3 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −2 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| −1 | K070961 | Biomerix Surgical Mesh, Model: RCR-01 | Biomerix Corporation | 2008 | — |
| 0 (this device) | K243480 | SuturePatch Tissue Reinforcement | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 9 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 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 OWX? 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 OWX device
- #1 K241219 FiberLocker System: FiberLocker Implant…score 14.5 · 11 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 |
|---|---|---|---|
| * | K070961 | Biomerix Surgical Mesh, Model: RCR-01Summary page 5…esh Product Code OWX, FTL Classification Name 21 CFR 878.3300 Surgical Mesh Regulatory Class II Primary Predicate Device K070961 Biomerix Surgical Mesh Additional Predicate Devices K122374 Arthrex Suture K190707 Arthrex SoftS… | 2008 |
| * | K122374 | Arthrex Suture (Uhmwpe)Summary page 5…e 21 CFR 878.3300 Surgical Mesh Regulatory Class II Primary Predicate Device K070961 Biomerix Surgical Mesh Additional Predicate Devices K122374 Arthrex Suture K190707 Arthrex SoftStitch Purpose of Submission This Traditional 510(k) p… | 2012 |
| * | K190707 | Arthrex SoftStitchSummary page 5…Class II Primary Predicate Device K070961 Biomerix Surgical Mesh Additional Predicate Devices K122374 Arthrex Suture K190707 Arthrex SoftStitch Purpose of Submission This Traditional 510(k) premarket notification is submitted to… | 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 2.0 years on median.
- 10 of the 89 ancestors have a recall of any class.
- 3 other devices also cite its predicate K070961.
How does its category compare?
All OWX devicesOWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OWX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWX
Too few OWX 510(k)s in any year since 2007 to give a median.
Recalls per year · OWX
No recall names OWX since 2007.
Adverse event reports per year · OWX
2in 2025
MAUDE reports naming product code OWX, 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 | 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 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SuturePatch Tissue Reinforcement is intended for the management and protection of soft tissue injuries. The SuturePatch Tissue Reinforcement is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures, or bone anchors used to attach the tissue…
Read the full statement (143 words)
The SuturePatch Tissue Reinforcement is intended for the management and protection of soft tissue injuries. The SuturePatch Tissue Reinforcement is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures, or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. The SuturePatch Tissue Reinforcement device reinforces and protects healing soft tissues.
The SuturePatch 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, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243480 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243480: SuturePatch Tissue Reinforcement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243480
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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