GRYPHON X Anchor; HEALIX TRANSTEND Anchor
FDA 510(k) K243790 · Depuy Mitek
510(k) numberK243790
Submission
- Device name
- GRYPHON X Anchor; HEALIX TRANSTEND Anchor
- Applicant
- Depuy Mitek
Raynham, MA, US - Received
- December 10, 2024
- Decision date
- February 5, 2025
- 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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| 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 |
|---|---|---|
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System LidKCT · Traditional | 02/26/2026SE |
| K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsMAI · Special | 09/11/2024SE |
| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewMAI · Special | 03/15/2024SE |
| K233675 | FMS VUE Fluid Management and Tissue Debridement SystemHRX · Traditional | 02/26/2024SE |
| K143475 | VAPR Tripolar Suction ElectrodeGEI · Traditional | 04/03/2015SE |
| K120449 | Healix Advance PEEK AnchorHWC · Traditional | 05/11/2012SE |
| K080918 | Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet…NEW · Special | 04/23/2008SE |
| K060664 | Fastin RC AnchorHWC · Traditional | 06/06/2006SE |
| K043298 | Blue Orthocord SutureNEW · Special | 12/10/2004SE |
| K041117 | Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC Quickanchor…JDR · Special | 05/28/2004SE |
Questions and answers
When was GRYPHON X Anchor; HEALIX TRANSTEND Anchor cleared by the FDA?
GRYPHON X Anchor; HEALIX TRANSTEND Anchor (K243790) received a 510(k) decision of Substantially Equivalent on February 5, 2025, 57 days after the submission was received.
What is the product code of K243790?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.