Bioabsorbable Anchor
FDA 510(k) K213958 · Embody, Inc.
510(k) numberK213958
Submission
- Device name
- Bioabsorbable Anchor
- Applicant
- Embody, Inc.
Norfolk, VA, US - Received
- December 17, 2021
- Decision date
- April 8, 2022
- 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 |
|---|---|---|
| K252647 | Tapestry Biointegrative ImplantOWY · Special | 09/19/2025SE |
| K223822 | ActivbraidGAT · Traditional | 06/02/2023SE |
| K220867 | Tapestry Biointegrative ImplantOWY · Traditional | 05/23/2022SE |
| K212306 | Tapestry Biointegrative ImplantOWY · Traditional | 11/02/2021SE |
| K201572 | TAPESTRY Biointegrative ImplantOWY · Traditional | 10/19/2020SE |
Questions and answers
When was Bioabsorbable Anchor cleared by the FDA?
Bioabsorbable Anchor (K213958) received a 510(k) decision of Substantially Equivalent on April 8, 2022, 112 days after the submission was received.
What is the product code of K213958?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.