Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H
FDA 510(k) K042966 · Linvatec Biomaterials, Ltd.
510(k) numberK042966
Submission
- Device name
- Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H
- Applicant
- Linvatec Biomaterials, Ltd.
Tampere, FI - Received
- October 28, 2004
- Decision date
- November 19, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | Arthrex, Inc. | 08/07/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | Arthrex, Inc. | 05/28/2026SE |
| K260294 | SF Push-in AnchorMAI · Traditional | Surgical Fusion Technologies GmbH | 03/27/2026SE |
| K254055 | OSSIOfiber® Suture AnchorMAI · Traditional | OSSIO , Ltd. | 02/24/2026SE |
| K251680 | Biosteon® ScrewMAI · Traditional | Biocomposites, Ltd. | 02/17/2026SE |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special | Conmed Corporation | 10/15/2025SE |
| K252022 | OSSIOfiber® Interference ScrewMAI · Traditional | OSSIO , Ltd. | 08/19/2025SE |
| K251309 | OSSIOfiber® Suture AnchorMAI · Special | OSSIO , Ltd. | 05/27/2025SE |
| K250544 | Knotilus+ Biocomposite Knotless AnchorMAI · Traditional | Stryker Endoscopy | 05/23/2025SE |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite AnchorMAI · Traditional | Stryker Endoscopy | 05/21/2025SE |
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| K042295 | Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020HWC · Special | 09/16/2004SE |
| K041288 | Modification to SmartpinHTY · Special | 06/10/2004SE |
| K032894 | Osteo Acl Screw MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…HWC · Traditional | 05/07/2004SE |
| K032447 | Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedHWC · Special | 04/16/2004SE |
| K031981 | 2.4 Smartnail, Models 532416, 532425, 532435, 532445MAI · Special | 07/25/2003SE |
Questions and answers
When was Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H cleared by the FDA?
Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H (K042966) received a 510(k) decision of Substantially Equivalent on November 19, 2004, 22 days after the submission was received.
What is the product code of K042966?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.