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 Aug 17, 2023 as substantially equivalent to K112423 (Rotation Medical, Inc., 2011) after a 267-day review. Its family tree reaches back 5 generations to 1985. 1 later device descends from it.
- Decided
- Aug 17, 2023
- Review
- 267 days
- Class
- Class II
- Product code
- OWX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K850785 (1985). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- 4 generations backK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- 3 generations backK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- 2 generations backK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- 1 generation backK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- This deviceK223538 Integrity ImplantAnika Therapeutics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK250997 Integrity™ ImplantAnika Therapeutics, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250997Integrity™ ImplantAnika Therapeutics, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K850785 | Fastube Nerve Regeneration Device | Research Medical, Inc. | 1985 | — |
| −4 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| −3 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| −2 | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| −1 | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| 0 (this device) | K223538 | Integrity Implant | Anika Therapeutics, Inc. | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K112423 | Collagen Tendon SheetSummary page 4…Classification Name: Mesh, Surgical (878.3300) Regulatory Class: II Product Code: OWX III. PREDICATE DEVICE Collagen Tendon Sheet, K112423 IV. REFERENCE DEVICES Versawrap Tendon Protector, K160364 Tapestry Biointegrative Implant, K201572… | 2011 |
| † | K160364 | VersaWrap Tendon Protector | 2016 |
| † | K201572 | TAPESTRY Biointegrative Implant | 2020 |
| † | K073251 | Hyalomatrix PA | 2007 |
| † | K211563 | Pitch-Patchs | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250997 | Integrity™ Implant | 2025 | 0 |
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 38 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K250997 (Anika Therapeutics, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K112423.
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. 2023, 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 as stated in the FDA summary.
https://510kreport.com/device/K223538 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223538: Integrity Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223538
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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