OIC Intramedullary Screw System
FDA 510(k) K223761 · Orthopaedic Implant Company
510(k) numberK223761
Submission
- Device name
- OIC Intramedullary Screw System
- Applicant
- Orthopaedic Implant Company
Reno, NV, US - Received
- December 15, 2022
- Decision date
- February 13, 2023
- 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 |
|---|---|---|
| K242995 | OIC Small / Mini Fragment Plate SystemHRS · Special | 10/23/2024SE |
| K233531 | OIC FLEX-FIX SystemHTN · Traditional | 02/02/2024SE |
| K223118 | OIC Variable Angle Small Fragment Locking Plate SystemHRS · Traditional | 01/21/2023SE |
| K212601 | DRPx Locking Distal Radius Plate SystemHRS · Traditional | 04/05/2022SE |
| K202971 | DRPx Locking Distal Radius Plate SystemHRS · Traditional | 05/06/2021SE |
| K211112 | OIC External Fixation SystemKTT · Special | 05/05/2021SE |
| K183682 | OIC External Fixation SystemKTT · Traditional | 04/08/2019SE |
| K182736 | OIC Suture Anchor SystemMBI · Traditional | 12/28/2018SE |
| K181184 | OIC Intramedullary Nail SystemHSB · Special | 07/27/2018SE |
| K171211 | OIC External Fixation SystemKTT · Traditional | 09/27/2017SE |
Questions and answers
When was OIC Intramedullary Screw System cleared by the FDA?
OIC Intramedullary Screw System (K223761) received a 510(k) decision of Substantially Equivalent on February 13, 2023, 60 days after the submission was received.
What is the product code of K223761?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.