510(k) · Cleared
ClearedResorbable Soft Tissue Attachment Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Aug 1, 1996 after an 84-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 1, 1996
- Review
- 84 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
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What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | Resorbable Soft Tissue Attachment Device manufactured by Zimmer Named without a submission number | |
| * | — | QuickAnchor™ manufactured by Mitek Named without a submission number | |
| * | — | Bio-Anchor™ Absorbable Suture Anchor manufactured by Linvatec Named without a submission number | |
| * | — | Statak® Soft Tissue Attachment Device manufactured by Zimmer 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 devices are intended for soft tissue to bone suture fixation for the following indications: Shoulder - Bankart lesion repairs - SLAP lesion repairs - Acromio-clavicular separations repairs - Rotator cuff tear repairs - Capsular shift or capsulolabral reconstructions - Biceps tenodesis - Deltoid repairs Foot and Ankle - Medial or lateral instability repairs/reconstructions - Achilles tendon repairs/reconstructions - Midfoot reconstructions - Hallux…
Read the full statement (112 words)
The devices are intended for soft tissue to bone suture fixation for the following indications:
Shoulder
- Bankart lesion repairs
- SLAP lesion repairs
- Acromio-clavicular separations repairs
- Rotator cuff tear repairs
- Capsular shift or capsulolabral reconstructions
- Biceps tenodesis
- Deltoid repairs
Foot and Ankle
- Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
- Midfoot reconstructions
- Hallux valgus reconstructions
Elbow, Wrist, and Hand
- Scapholunate ligament reconstructions
- Ulnar or radial collateral ligament reconstructions
- Tennis elbow repair
- Biceps tendon reattachment
Knee
- Extra-capsular repairs
-- medial collateral ligament
-- lateral collateral ligament
-- posterior oblique ligament
- Iliotibial band tenodesis
- Patellar tendon repairs
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/K961789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961789: Resorbable Soft Tissue Attachment Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961789
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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