Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
FDA 510(k) K210122 · Osteonic Co., Ltd.
510(k) numberK210122
Submission
- Device name
- Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
- Applicant
- Osteonic Co., Ltd.
Guro-Gu, KR - Received
- January 19, 2021
- Decision date
- August 27, 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
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| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | Arthrex, Inc. | 08/07/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | Arthrex, Inc. | 05/28/2026SE |
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| K254055 | OSSIOfiber® Suture AnchorMAI · Traditional | OSSIO , Ltd. | 02/24/2026SE |
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| 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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| K243470 | Fix2Lock (PEEK Self Punching)MBI · Special | 12/03/2024SE |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)MAI · Special | 12/03/2024SE |
| K230546 | SignexHRS · Traditional | 06/11/2024SE |
| K233659 | Suture WingMBI · Special | 12/26/2023SE |
| K231322 | Fix2Lock(PEEK Self Punching)MBI · Special | 06/07/2023SE |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)MAI · Special | 05/31/2023SE |
| K210360 | Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro…GWO · Traditional | 01/27/2022SE |
| K211992 | Ortho MI SystemOAT · Traditional | 10/15/2021SE |
Questions and answers
When was Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) cleared by the FDA?
Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) (K210122) received a 510(k) decision of Substantially Equivalent on August 27, 2021, 220 days after the submission was received.
What is the product code of K210122?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.