510(k) · Cleared
Recalled · Class II · 2025Fixone Meniscal Repair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aju Pharm Co., Ltd. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Aug 2, 2024 as substantially equivalent to K153667 (Medos International SARL, 2016) and 1 other predicate after a 267-day review. Its family tree reaches back 5 generations to 2005. It has been recalled 8 times.
- Decided
- Aug 2, 2024
- Review
- 267 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 5 generations to K050021 (2005). 12 ancestors in all, the oldest K925573 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK050021 Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. · 2005
- 4 generations backK070216 Vari-Lase Bright Tip FiberVascular Solutions, Inc. · 2007
- 3 generations backK072332 Vari-Lase Wire FiberVascular Solutions, Inc. · 2008 · Recalled
- 2 generations backK121861 Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew…Smith & Nephew, Inc. · 2012
- 1 generation backK153667 TRUESPAN Meniscal Repair SystemMedos International SARL · 2016
- This deviceK233601 Fixone Meniscal RepairAju Pharm Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K050021 | Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit | Vascular Solutions, Inc. | 2005 | — |
| −4 | K070216 | Vari-Lase Bright Tip Fiber | Vascular Solutions, Inc. | 2007 | — |
| −3 | K072332 | Vari-Lase Wire Fiber | Vascular Solutions, Inc. | 2008 | 1 |
| −2 | K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra… | Smith & Nephew, Inc. | 2012 | — |
| −1 | K153667 | TRUESPAN Meniscal Repair System | Medos International SARL | 2016 | — |
| 0 (this device) | K233601 | Fixone Meniscal Repair | Aju Pharm Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 3 | 0 |
| 2010 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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 |
|---|---|---|---|
| * | K153667 | TRUESPAN Meniscal Repair SystemSummary page 4…888.3040 6) Class of device : Class II 7) Panel : Orthopedic 3. The legally marketed device to which we are claiming equivalence Primary Predicate K153667, DePuy Synthes/ TRUESPAN Meniscal Repair System (Product Code: MBI) Additional Predicate K121861, Smith & Nephew Inc.… | 2016 |
| * | K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…Summary page 4…which we are claiming equivalence Primary Predicate K153667, DePuy Synthes/ TRUESPAN Meniscal Repair System (Product Code: MBI) Additional Predicate K121861, Smith & Nephew Inc. / FAST-FIX Meniscal Repair System (Product Code: GAT) Reference Device K203523, Aju Pharm Co., Lt… | 2012 |
| † | K203523 | Fixone hybrid knotless anchor | 2021 |
| † | K230892 | Fixone Biocomposite Anchor | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 17, 2025 | Class II | Z-1167-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Dec 17, 2025 | Class II | Z-1170-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Dec 17, 2025 | Class II | Z-1166-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Dec 17, 2025 | Class II | Z-1172-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Dec 17, 2025 | Class II | Z-1168-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Dec 17, 2025 | Class II | Z-1171-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Dec 17, 2025 | Class II | Z-1173-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Dec 17, 2025 | Class II | Z-1169-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 12 ancestors have a recall of any class.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, 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 · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The Fixone Meniscal Repair is intended to suture the meniscus tear to facilitate percutaneous or endoscopic soft tissue procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233601: Fixone Meniscal Repair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233601
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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