510(k) · Cleared
ClearedMultitak 6.0 MM Absorbable Anchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonutti Research, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Dec 16, 2005 after a 74-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 16, 2005
- Review
- 74 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Stryker BioZip Suture Anchor Named without a submission number | |
| * | — | Multitak suture anchors Named without a submission number |
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.
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 Multitak 6.0 mm Absorbable Anchor System consists of a single use absorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open surgical procedures. The Multitak 6.0 mm Absorbable Anchor System is indicated for use in securing soft tissue to bone in such applications as the following: Shoulder: Bankart lesion repairs Acromio-clavicular…
Read the full statement (150 words)
The Multitak 6.0 mm Absorbable Anchor System consists of a single use absorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open surgical procedures.
The Multitak 6.0 mm Absorbable Anchor System is indicated for use in securing soft tissue to bone in such applications as the following:
Shoulder:
Bankart lesion repairs
Acromio-clavicular repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis
SLAP lesion repairs
Elbow, Wrist, & Hand:
Scapholunate ligament reconstruction
Ulnar collateral ligament reconstruction
Radial collateral ligament reconstruction
Biceps tendon reattachment
Knee:
Extra-capsular repairs
Medial collateral ligament repair
Lateral collateral ligament repair
Posterior oblique ligament repair
Illiotibial band tenodesis
Patellar tendon repair
VMO advancement
Joint capsule closure
Foot & Ankle:
Medial instability repair/reconstruction
Lateral instability repair/reconstruction
Achilles instability repair/reconstruction
Midfoot reconstruction
Hallux valgus reconstruction
Pelvis
Bladder neck suspension procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052799 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052799: Multitak 6.0 MM Absorbable Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052799
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026