Fixone Biocomposite Interference Screw
FDA 510(k) K193497 · Aju Pharm Co., Ltd.
510(k) numberK193497
Submission
- Device name
- Fixone Biocomposite Interference Screw
- Applicant
- Aju Pharm Co., Ltd.
Seongnam-Si, KR - Received
- December 17, 2019
- Decision date
- January 5, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233601 | Fixone Meniscal RepairMBI · Traditional | 08/02/2024SE |
| K230892 | Fixone Biocomposite AnchorMAI · Special | 06/09/2023SE |
| K222423 | Fixone All Suture AnchorMBI · Special | 03/23/2023SE |
| K203523 | Fixone hybrid knotless anchorMAI · Traditional | 12/25/2021SE |
| K192709 | Fixone All Suture AnchorMBI · Traditional | 12/15/2020SE |
| K192484 | Fixone Biocomposite AnchorMAI · Special | 03/11/2020SE |
| K192032 | Fixone Biocomposite Small AnchorMAI · Traditional | 03/03/2020SE |
| K171299 | Fixone Biocomposite AnchorMAI · Traditional | 08/24/2017SE |
| K162070 | Joinix Cannular SystemHRX · Traditional | 03/16/2017SE |
Questions and answers
When was Fixone Biocomposite Interference Screw cleared by the FDA?
Fixone Biocomposite Interference Screw (K193497) received a 510(k) decision of Substantially Equivalent on January 5, 2021, 385 days after the submission was received.
What is the product code of K193497?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.