Endobutton Direct
FDA 510(k) K102982 · Smith & Nephew Inc., Endoscopy Division
510(k) numberK102982
Submission
- Device name
- Endobutton Direct
- Applicant
- Smith & Nephew Inc., Endoscopy Division
Andover, MA, US - Received
- October 7, 2010
- Decision date
- January 5, 2011
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K121904 | Gynecology Sterilization TrayKCT · Traditional | 03/11/2013SE |
| K082215 | Osteoraptor Suture AnchorJDR · Traditional | 11/03/2008SE |
| K081098 | Endobutton Continuous Loop (CL)JDR · Traditional | 07/16/2008SE |
| K072785 | Twinfix FT PKHWC · Traditional | 12/10/2007SE |
| K071586 | Bioraptor 2.3 PK Suture AnchorMBI · Traditional | 08/17/2007SE |
| K070908 | Smith & Nephew Kinsa RC Suture AnchorMBI · Traditional | 05/16/2007SE |
| K070167 | Endobutton DirectMBI · Traditional | 04/12/2007SE |
Questions and answers
When was Endobutton Direct cleared by the FDA?
Endobutton Direct (K102982) received a 510(k) decision of Substantially Equivalent on January 5, 2011, 90 days after the submission was received.
What is the product code of K102982?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.