510(k) · Cleared
ClearedRotium Bioresorbable Wick
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanofiber Solutions, LLC · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Jul 5, 2023 as substantially equivalent to K183236 (Nanofiber Solutions, LLC, 2019) and 1 other predicate after a 30-day review. Its family tree reaches back 15 generations to 1991. 1 later device descends from it.
- Decided
- Jul 5, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K911837 (1991). 102 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 11 generations between
- 3 generations backK172186 BioWick X Implant with DriverCayenne Medical, Inc. · 2017
- 2 generations backK183236 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2019
- 1 generation backK201414 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2020
- This deviceK231641 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2023
- Descendant · cites it directly · 0 of its ownK241912 BiochargeNanofiber Solutions, LLC · 2024
Show all 15 generations
- Root · 15 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 14 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 13 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 12 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 11 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 10 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 9 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 8 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 7 generations backK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- 6 generations backK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- 5 generations backK132867 Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture…Cayenne Medical, Inc. · 2013
- 4 generations backK151068 SureLock W Suture AnchorCayenne Medical, Inc. · 2015
- 3 generations backK172186 BioWick X Implant with DriverCayenne Medical, Inc. · 2017
- 2 generations backK183236 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2019
- 1 generation backK201414 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2020
- This deviceK231641 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K241912BiochargeNanofiber Solutions, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −14 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −13 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −12 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −11 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −10 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −9 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −8 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −7 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| −6 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| −5 | K132867 | Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor… | Cayenne Medical, Inc. | 2013 | — |
| −4 | K151068 | SureLock W Suture Anchor | Cayenne Medical, Inc. | 2015 | — |
| −3 | K172186 | BioWick X Implant with Driver | Cayenne Medical, Inc. | 2017 | — |
| −2 | K183236 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | 2019 | — |
| −1 | K201414 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | 2020 | — |
| 0 (this device) | K231641 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | 2023 | — |
| +1 | K241912 | Biocharge | Nanofiber Solutions, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 14 | 0 |
| 1997 | 12 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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? (2)
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 |
|---|---|---|---|
| * | K183236 | Rotium Bioresorbable WickSummary page 4…appliances and accessories (21 CFR 888.3030) Regulatory Class: Class II Product Code: MAI Primary Predicate Device: Rotium™ Bioresorbable Wick, K183236, K201414 Reason for Submission: Updating labeling to allow for placement on top of the rotator cuff t… | 2019 |
| * | K201414 | Rotium Bioresorbable WickSummary page 4…ces and accessories (21 CFR 888.3030) Regulatory Class: Class II Product Code: MAI Primary Predicate Device: Rotium™ Bioresorbable Wick, K183236, K201414 Reason for Submission: Updating labeling to allow for placement on top of the rotator cuff tendon.… | 2020 |
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 |
|---|---|---|---|
| K241912 | Biocharge | 2024 | 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 32 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 14 of the 102 ancestors have a recall of any class.
- Of its descendants, K241912 (Nanofiber Solutions, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K183236.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Rotium™ Bioresorbable Wick is intended to be used in conjunction with suture anchors for the reattachment of tendon to bone in rotator cuff repairs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231641 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231641: Rotium Bioresorbable Wick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231641
Report an extraction error
Are you the manufacturer?
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