510(k) · Cleared
ClearedRotium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanofiber Solutions, LLC · OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Cleared on Feb 27, 2025 as substantially equivalent to K201572 (Embody, Inc., 2020) after a 55-day review. Its family tree reaches back 6 generations to 1985.
- Decided
- Feb 27, 2025
- Review
- 55 days
- Class
- Class II
- Product code
- OWW
- 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 backK201572 TAPESTRY Biointegrative ImplantEmbody, Inc. · 2020
- This deviceK250021 RotiumNanofiber Solutions, LLC · 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 | K201572 | TAPESTRY Biointegrative Implant | Embody, Inc. | 2020 | — |
| 0 (this device) | K250021 | Rotium | Nanofiber Solutions, LLC | 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 OWW? 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 OWW device
- #1 K241906 BioBrace® Reinforced Implantscore 17.1 · 12 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 |
|---|---|---|---|
| * | K201572 | TAPESTRY Biointegrative ImplantSummary page 5…cation Name: Surgical Mesh (21 CFR 878.3300) Regulatory Class: Class II Product Code: OWW Predicate Device(s): TAPESTRY Biointegrative Implant (K201572) Reference Device(s): Rotium Bioresorbable Wick (K183236, K201414, K231641) Reason for Submission: New Device Indi… | 2020 |
| † | K183236 | Rotium Bioresorbable Wick | 2019 |
| † | K201414 | Rotium Bioresorbable Wick | 2020 |
| † | K231641 | Rotium Bioresorbable Wick | 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 5 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 2 other devices also cite its predicate K201572.
How does its category compare?
All OWW devicesOWW Mesh, Surgical, 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 · OWW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWW
81in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWW
No recall names OWW since 2007.
Adverse event reports per year · OWW
2in 2025
MAUDE reports naming product code OWW, 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 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 3 | 81 | 0 | 0 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Rotium® 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/K250021 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250021: Rotium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250021
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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