MICRORAPTOR REGENESORB Suture Anchor
FDA 510(k) K180361 · Smith and Nephew, Inc.
510(k) numberK180361
Submission
- Device name
- MICRORAPTOR REGENESORB Suture Anchor
- Applicant
- Smith and Nephew, Inc.
Cordova, TN, US - Received
- February 9, 2018
- Decision date
- May 30, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code MAI
| 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 |
More from Stryker Endoscopy
| 510(k) | Device | Decision |
|---|---|---|
| K222501 | Regeneten Bioinductive ImplantOWY · Traditional | 05/11/2023SE |
| K221740 | Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith &…GCJ · Traditional | 10/20/2022SE |
| K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…GCJ · Traditional | 08/23/2019SE |
| K183232 | Double ENDOBUTTON Fixation DeviceHTN · Traditional | 03/12/2019SE |
| K181746 | MICRORAPTOR Knotless Suture AnchorMAI · Traditional | 09/28/2018SE |
| K163034 | SUTUREFIX Curved Suture AnchorMBI · Traditional | 12/07/2016SE |
Questions and answers
When was MICRORAPTOR REGENESORB Suture Anchor cleared by the FDA?
MICRORAPTOR REGENESORB Suture Anchor (K180361) received a 510(k) decision of Substantially Equivalent on May 30, 2018, 110 days after the submission was received.
What is the product code of K180361?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.