OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
FDA 510(k) K212912 · B-One Ortho, Corp.
510(k) numberK212912
Submission
- Device name
- OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
- Applicant
- B-One Ortho, Corp.
Cedar Knolls, NJ, US - Received
- September 13, 2021
- Decision date
- November 4, 2021
- 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 |
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| K240528 | b-ONE® Total Hip SystemLZO · Traditional | 11/15/2024SE |
| K222431 | b-ONER MOBIO Total Knee SystemJWH · Traditional | 10/06/2022SE |
| K213673 | b-ONE MOBIO Total Knee SystemJWH · Traditional | 01/21/2022SE |
| K210483 | MOBIO Total Knee SystemJWH · Traditional | 04/21/2021SE |
| K202768 | KOSMO Femoral StemLZO · Traditional | 04/01/2021SE |
| K202429 | Mobio Total Knee SystemJWH · Traditional | 10/23/2020SE |
| K182705 | Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System CupsLZO · Traditional | 02/14/2019SE |
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Questions and answers
When was OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System cleared by the FDA?
OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System (K212912) received a 510(k) decision of Substantially Equivalent on November 4, 2021, 52 days after the submission was received.
What is the product code of K212912?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.