510(k) · Cleared
Cleared5.0MM Parachute Corkscrew Suture Anchor Model AR-22255, 3.5MM Parachute Corkscrew Suture Anchor Model AR-22235
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Aug 6, 1998 after a 220-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Aug 6, 1998
- Review
- 220 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK974847 5.0MM Parachute Corkscrew Suture Anchor Model AR-22255, 3.5MM…Arthrex, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK162429 ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC · 2017
- Descendant · 2 generations on · 2 of its ownK200028 Coronet Soft Tissue Fixation SystemConextions Medical · 2020
- Descendant · 3 generations on · 1 of its ownK220966 SinefixBAAT Medical Products B.V. · 2023
- Descendant · 2 generations on · 1 of its ownK191227 Paratrooper Plantar Plate Repair SystemParagon 28, Inc. · 2020
- Descendant · 4 generations on · 0 of its ownK254176 SinefixBAAT Medical Products B.V. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K162429ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC · 2017 · cites it directly5descendants
- K200028Coronet Soft Tissue Fixation SystemConextions Medical · 2020 · 2 generations on2descendants
- K220966SinefixBAAT Medical Products B.V. · 2023 · 3 generations on1descendant
- K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc. · 2020 · 2 generations on1descendant
- K254176SinefixBAAT Medical Products B.V. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974847 | 5.0MM Parachute Corkscrew Suture Anchor Model AR-22255, 3.5MM Parachute… | Arthrex, Inc. | 1998 | — |
| +1 | K162429 | ZipE Knotless Tissue Repair and Attachment Devices | Ziptek, LLC | 2017 | — |
| +2 | K200028 | Coronet Soft Tissue Fixation System | Conextions Medical | 2020 | — |
| +3 | K220966 | Sinefix | BAAT Medical Products B.V. | 2023 | — |
| +2 | K191227 | Paratrooper Plantar Plate Repair System | Paragon 28, Inc. | 2020 | — |
| +4 | K254176 | Sinefix | BAAT Medical Products B.V. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Arthrex FASTak Named without a submission number | |
| * | — | Linvatec Bio-Anchor Named without a submission number |
What descends from it? (7)
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?
- Of its descendants, K162429 (Ziptek, LLC, 2017) has gone furthest, with 5 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.
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 Parachute Corkscrew Suture Anchor is intended for fixation of tissue to bone. This product is intended for the following indications: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Cap§ulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction…
Read the full statement (102 words)
The Parachute Corkscrew Suture Anchor is intended for fixation of tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Cap§ulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist. Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligamant Reconstruction
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/K974847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974847: 5.0MM Parachute Corkscrew Suture Anchor Model AR-22255, 3.5MM Parachute Corkscrew Suture Anchor Model AR-22235.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974847
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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