510(k) · Cleared
ClearedContour Meniscus Arrow, Models 541110, 541113, and 541116
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionx Implants, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Sep 19, 2001 as substantially equivalent to K955768 (Bioscience, Inc., 1996) and 1 other predicate after a 57-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Sep 19, 2001
- Review
- 57 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K925573 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993 · Recalled
- 2 generations backK955768 Biofix Biodegradable Meniscus Arrow SystemBioscience, Inc. · 1996
- 1 generation backK993453 Meniscus Arrow, Models 531110, 531113, 531116Bionx Implants, Ltd. · 1999
- This deviceK012334 Contour Meniscus Arrow, Models 541110, 541113, and 541116Bionx Implants, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK041128 Suture ArrowLinvatec Corp. · 2004
Most influential descendants
Showing 1 of 1 · See all- K041128Suture ArrowLinvatec Corp. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925573 | Acufex T-Bar | Acufex Microsurgical, Inc. | 1993 | 1 |
| −2 | K955768 | Biofix Biodegradable Meniscus Arrow System | Bioscience, Inc. | 1996 | — |
| −1 | K993453 | Meniscus Arrow, Models 531110, 531113, 531116 | Bionx Implants, Ltd. | 1999 | — |
| 0 (this device) | K012334 | Contour Meniscus Arrow, Models 541110, 541113, and 541116 | Bionx Implants, Inc. | 2001 | — |
| +1 | K041128 | Suture Arrow | Linvatec Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K955768 | Biofix Biodegradable Meniscus Arrow SystemSummary page 1…ation Name: Biodegradable soft tissue fixation fastener D. Device Product Code: MAI Predicate Devices: Bionx Implants Inc. Biofix® Biodegradable Meniscus Arrow System (K955768) Bionx Implants Inc. Meniscus Arrow™ (K993453) Intended Use: The Contour Meniscus Arrow™ is intended for arthros… | 1996 |
| * | K993453 | Meniscus Arrow, Models 531110, 531113, 531116Summary page 1…fastener D. Device Product Code: MAI Predicate Devices: Bionx Implants Inc. Biofix® Biodegradable Meniscus Arrow System (K955768) Bionx Implants Inc. Meniscus Arrow™ (K993453) Intended Use: The Contour Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical menisc… | 1999 |
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 |
|---|---|---|---|
| K041128 | Suture Arrow | 2004 | 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 8 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K041128 (Linvatec Corp., 2004) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K955768.
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.
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 Contour Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. “red-red” and “red-white” zones) in conjunction with immobilization during healing.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012334 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012334: Contour Meniscus Arrow, Models 541110, 541113, and 541116.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012334
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026