510(k) · Cleared
ClearedBiocharge
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 29, 2024 as substantially equivalent to K231641 (Nanofiber Solutions, LLC, 2023) and 2 other predicates after a 28-day review. Its family tree reaches back 16 generations to 1991.
- Decided
- Jul 29, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K911837 (1991). 103 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 16 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 12 generations between
- 3 generations backK183236 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2019
- 2 generations backK201414 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2020
- 1 generation backK231641 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2023
- This deviceK241912 BiochargeNanofiber Solutions, LLC · 2024
Show all 16 generations
- Root · 16 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 15 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 14 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 13 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 12 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 11 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 10 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 9 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 8 generations backK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- 7 generations backK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- 6 generations backK132867 Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture…Cayenne Medical, Inc. · 2013
- 5 generations backK151068 SureLock W Suture AnchorCayenne Medical, Inc. · 2015
- 4 generations backK172186 BioWick X Implant with DriverCayenne Medical, Inc. · 2017
- 3 generations backK183236 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2019
- 2 generations backK201414 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2020
- 1 generation backK231641 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2023
- This deviceK241912 BiochargeNanofiber Solutions, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −15 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −14 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −13 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −12 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −11 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −10 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −9 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −8 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| −7 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| −6 | K132867 | Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor… | Cayenne Medical, Inc. | 2013 | — |
| −5 | K151068 | SureLock W Suture Anchor | Cayenne Medical, Inc. | 2015 | — |
| −4 | K172186 | BioWick X Implant with Driver | Cayenne Medical, Inc. | 2017 | — |
| −3 | K183236 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | 2019 | — |
| −2 | K201414 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | 2020 | — |
| −1 | K231641 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | 2023 | — |
| 0 (this device) | 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 |
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? (3)
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 |
|---|---|---|---|
| * | K231641 | 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, K231641 Reference Device: Rotium® Bioresorbable Wick, K183236 Reason for Submission: Design updates to facilitate suture pass… | 2023 |
| * | K201414 | Rotium Bioresorbable WickSummary page 5…icate. The design change will have no impact on the Biocompatibility or Animal Testing results of the predicate (K231641, K201414, K183236). Substantial Equivalence: BIOCHARGE™ is substantially equivalent to the predicate, Rotium™ Bi… | 2020 |
| * | K183236 | Rotium Bioresorbable WickSummary page 4…ory Class: Class II Product Code: MAI Primary Predicate Device: Rotium® Bioresorbable Wick, K231641 Reference Device: Rotium® Bioresorbable Wick, K183236 Reason for Submission: Design updates to facilitate suture passage through the device. Indic… | 2019 |
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 9 companies; a new generation was cleared every 1.6 years on median.
- 14 of the 103 ancestors have a recall of any class.
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. 2024, 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?
BIOCHARGE™ 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/K241912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241912: Biocharge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241912
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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