510(k) · Cleared
ClearedIntegrity™ Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anika Therapeutics, Inc. · OWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
Cleared on Jun 17, 2025 as substantially equivalent to K223538 (Anika Therapeutics, Inc., 2023) after a 77-day review. Its family tree reaches back 6 generations to 1985.
- Decided
- Jun 17, 2025
- Review
- 77 days
- Class
- Class II
- Product code
- OWX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K850785 (1985). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- 5 generations backK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- 4 generations backK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- 3 generations backK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- 2 generations backK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- 1 generation backK223538 Integrity ImplantAnika Therapeutics, Inc. · 2023
- This deviceK250997 Integrity™ ImplantAnika Therapeutics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K850785 | Fastube Nerve Regeneration Device | Research Medical, Inc. | 1985 | — |
| −5 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| −4 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| −3 | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| −2 | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| −1 | K223538 | Integrity Implant | Anika Therapeutics, Inc. | 2023 | — |
| 0 (this device) | K250997 | Integrity™ Implant | Anika Therapeutics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K223538 | Integrity ImplantSummary page 5…OWX Review Panel Orthopedic Predicate 510(k) Number Integrity™ Implant- K223538 Reason for Submission The purpose of this 510(k) is to obtain clearance for new sizes for Integrity Implant with same indication… | 2023 |
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 40 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 11 ancestors have a recall of any class.
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 Integrity Implant is indicated for the management and protection of tendon injuries in which
there has been no substantial loss of tendon tissue.
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/K250997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250997: Integrity™ Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250997
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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