510(k) · Cleared
ClearedM-ARS ACL: Anatomic Ribbon Surgery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Oct 23, 2017 as substantially equivalent to K982571 (KARL STORZ Endoscopy-America, Inc., 1998) and 1 other predicate after a 143-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it.
- Decided
- Oct 23, 2017
- Review
- 143 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K982571 (1998). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK982571 Ksea FlipptackKARL STORZ Endoscopy-America, Inc. · 1998
- This deviceK171640 M-ARS ACL: Anatomic Ribbon Surgery SystemMedacta International S.A. · 2017
- Descendant · cites it directly · 3 of its ownK191300 MectaLock Ti Suture AnchorMedacta International S.A. · 2019
- Descendant · 2 generations on · 2 of its ownK223582 MectaLock TI Triple Loaded Suture AnchorMedacta International S.A. · 2023
- Descendant · 3 generations on · 1 of its ownK230544 SnugFit All-Suture Anchor extensionMedacta International S.A. · 2023
- Descendant · 4 generations on · 0 of its ownK251933 SnugFit ASA ExtensionMedacta International S.A. · 2025
- Descendant · cites it directly · 0 of its ownK221389 FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A. · 2022
Most influential descendants
Showing 5 of 5 · See all- K191300MectaLock Ti Suture AnchorMedacta International S.A. · 2019 · cites it directly3descendants
- K223582MectaLock TI Triple Loaded Suture AnchorMedacta International S.A. · 2023 · 2 generations on2descendants
- K230544SnugFit All-Suture Anchor extensionMedacta International S.A. · 2023 · 3 generations on1descendant
- K251933SnugFit ASA ExtensionMedacta International S.A. · 2025 · 4 generations on0descendants
- K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982571 | Ksea Flipptack | KARL STORZ Endoscopy-America, Inc. | 1998 | — |
| 0 (this device) | K171640 | M-ARS ACL: Anatomic Ribbon Surgery System | Medacta International S.A. | 2017 | — |
| +1 | K191300 | MectaLock Ti Suture Anchor | Medacta International S.A. | 2019 | — |
| +2 | K223582 | MectaLock TI Triple Loaded Suture Anchor | Medacta International S.A. | 2023 | — |
| +3 | K230544 | SnugFit All-Suture Anchor extension | Medacta International S.A. | 2023 | — |
| +4 | K251933 | SnugFit ASA Extension | Medacta International S.A. | 2025 | — |
| +1 | K221389 | FairFix AM Adjustable Button FairFix PSP Adjustable Button | Medacta International S.A. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K982571 | Ksea FlipptackSummary page 4…ber: 21 CFR 888.3040 Device Classification 2 III. Predicate Device Substantial equivalence is claimed to the following devices: • KSEA Flipptack, K982571, Karl Storz Endoscopy – America, Inc. (also referred to as Karl Storz’s Flipptack) • Endotack, K022853, Karl Storz Endosco… | 1998 |
| * | K022853 | EndotackSummary page 4…ce is claimed to the following devices: • KSEA Flipptack, K982571, Karl Storz Endoscopy – America, Inc. (also referred to as Karl Storz’s Flipptack) • Endotack, K022853, Karl Storz Endoscopy – America, Inc. The following reference devices are cited within the submission: • M.U.S.T. Extension,… | 2002 |
| † | K132878 | M.U.S.T. Extension | 2013 |
| † | K141988 | M.U.S.T Pedicle Screw System | 2014 |
| † | K153664 | M.U.S.T. Pedicle Screw System | 2016 |
| † | K162061 | M.U.S.T. Pedicle Screw System | 2016 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K191300 (Medacta International S.A., 2019) has gone furthest, with 3 descendants of its own.
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. 2017, 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?
M-ARS ACL: Anatomic Ribbon Surgery System - M-ARS ACL Tibial Pull Suture Plate (PSP):
Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous grafts.
M-ARS ACL: Anatomic Ribbon Surgery System: M-ARS ACL Extracortical Femoral Button:
Reconstructive therapy of ruptures to the anterior and posterior cruciate ligament by means of autologous grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171640: M-ARS ACL: Anatomic Ribbon Surgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171640
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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