Knotilus+ Biocomposite Knotless Anchor
FDA 510(k) K250544 · Stryker Endoscopy
510(k) numberK250544
Submission
- Device name
- Knotilus+ Biocomposite Knotless Anchor
- Applicant
- Stryker Endoscopy
San Jose, CA, US - Received
- February 25, 2025
- Decision date
- May 23, 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
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 |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite AnchorMAI · Traditional | Stryker Endoscopy | 05/21/2025SE |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mmMAI · Traditional | OSSIO , Ltd. | 04/03/2025SE |
More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair…MBI · Special | 07/30/2026SE |
| K253602 | Precision S 4K SinuscopeGWG · Traditional | 06/04/2026SE |
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional | 05/28/2026SE |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…GCJ · Special | 02/18/2026SE |
| K260108 | L12 LED Light Source with AIMOWN · Special | 02/12/2026SE |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with…GCJ · Special | 01/13/2026SE |
| K253888 | MOLLI 2 SystemNEU · Special | 12/31/2025SE |
| K252010 | SPY LaparoscopeGCJ · Special | 07/24/2025SE |
| K252012 | SPY Cystoscope/HysteroscopeHIH · Special | 07/18/2025SE |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite AnchorMAI · Traditional | 05/21/2025SE |
Questions and answers
When was Knotilus+ Biocomposite Knotless Anchor cleared by the FDA?
Knotilus+ Biocomposite Knotless Anchor (K250544) received a 510(k) decision of Substantially Equivalent on May 23, 2025, 87 days after the submission was received.
What is the product code of K250544?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.