Sutureless Anchor
FDA 510(k) K984490 · Innovasive Devices, Inc.
510(k) numberK984490
Submission
- Device name
- Sutureless Anchor
- Applicant
- Innovasive Devices, Inc.
Marlboro, MA, US - Received
- December 17, 1998
- Decision date
- March 1, 1999
- 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 |
|---|---|---|
| K994269 | Titan RC TackMAI · Special | 01/10/2000SE |
| K993975 | Absolute Absorbable Interference ScrewHWC · Special | 12/20/1999SE |
| K992458 | RC Multisuture Bone Anchor, Model 4453/4454MBI · Traditional | 10/14/1999SE |
| K992377 | RC TackMBI · Traditional | 10/08/1999SE |
| K990454 | Bio-Interference ScrewHWC · Traditional | 07/01/1999SE |
| K983560 | Innovasive Devices Intratunnel Tibial Fixation FastenerMBI · Traditional | 01/28/1999SE |
| K983056 | Innovasive Tibial FastenerMBI · Traditional | 10/13/1998SE |
| K981340 | Innovasive Devices Meniscal Dart Repair SystemMAI · Traditional | 06/22/1998SE |
| K981193 | Innovasive 3.5MM Metal Roc XS Suture Bone FastenerMBI · Traditional | 06/16/1998SE |
| K980681 | Innovasive Devices Meniscal ScrewHWC · Traditional | 04/29/1998SE |
Questions and answers
When was Sutureless Anchor cleared by the FDA?
Sutureless Anchor (K984490) received a 510(k) decision of Substantially Equivalent on March 1, 1999, 74 days after the submission was received.
What is the product code of K984490?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.