510(k) · Cleared
ClearedArthrex SpeedFLEX™ Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Cleared on Sep 30, 2025 as substantially equivalent to K103787 (Kensey Nash Corp., 2011) after a 120-day review. Its family tree reaches back 11 generations to 1992.
- Decided
- Sep 30, 2025
- Review
- 120 days
- Class
- Class II
- Product code
- OWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K921895 (1992). 50 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations between
- 3 generations backK080353 LTM-T Surgical MeshLifecell Corp. · 2008
- 2 generations backK091499 Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp. · 2009
- 1 generation backK103787 Medeor MatrixKensey Nash Corp. · 2011
- This deviceK251690 Arthrex SpeedFLEX™ ImplantArthrex, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 10 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 9 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 8 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 7 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 6 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 5 generations backK043388 Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc. · 2005
- 4 generations backK071065 Orthadapt BioimplantPegasus Biologics, Inc. · 2007
- 3 generations backK080353 LTM-T Surgical MeshLifecell Corp. · 2008
- 2 generations backK091499 Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp. · 2009
- 1 generation backK103787 Medeor MatrixKensey Nash Corp. · 2011
- This deviceK251690 Arthrex SpeedFLEX™ ImplantArthrex, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −10 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −9 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −8 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −7 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −6 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −5 | K043388 | Pegasus Biologics Orthadapt Surgical Mesh | Pegasus Biologics, Inc. | 2005 | — |
| −4 | K071065 | Orthadapt Bioimplant | Pegasus Biologics, Inc. | 2007 | — |
| −3 | K080353 | LTM-T Surgical Mesh | Lifecell Corp. | 2008 | — |
| −2 | K091499 | Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry) | Kensey Nash Corp. | 2009 | — |
| −1 | K103787 | Medeor Matrix | Kensey Nash Corp. | 2011 | — |
| 0 (this device) | K251690 | Arthrex SpeedFLEX™ Implant | 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 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 OWY? 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 OWY device
- #1 K222501 Regeneten Bioinductive Implantscore 13.1 · 7 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 |
|---|---|---|---|
| * | K103787 | Medeor MatrixSummary page 5…CFR 878.5000: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class Class II Primary Predicate Device K103787: Medeor™ Matrix Reference Device K120479: MTF Fascia Purpose of Submission This Traditional 510(k) premarket notif… | 2011 |
| † | K120479 | MTF Fascia | 2012 |
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 8 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 50 ancestors have a recall of any class.
- 1 other device also cites its predicate K103787.
How does its category compare?
All OWY devicesOWY Mesh, Surgical, Collagen, 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 · OWY
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWY
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWY
No recall names OWY since 2007.
Adverse event reports per year · OWY
28in 2025
MAUDE reports naming product code OWY, 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 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 1 | — | 0 | 14 |
| 2021 | 1 | — | 0 | 25 |
| 2022 | 1 | — | 0 | 15 |
| 2023 | 1 | — | 0 | 35 |
| 2024 | 1 | — | 0 | 24 |
| 2025 | 4 | 131 | 0 | 28 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Arthrex SpeedFLEX™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The Arthrex SpeedFLEX™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including but not limited to reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The Arthrex SpeedFLEX™ Implant is not intended to…
Read the full statement (113 words)
The Arthrex SpeedFLEX™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The Arthrex SpeedFLEX™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including but not limited to reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The Arthrex SpeedFLEX™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251690 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251690: Arthrex SpeedFLEX™ Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251690
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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