MectaScrew Extension
FDA 510(k) K203335 · Medacta International S.A.
510(k) numberK203335
Submission
- Device name
- MectaScrew Extension
- Applicant
- Medacta International S.A.
Castel San Pietro (Ch), CH - Received
- November 12, 2020
- Decision date
- February 3, 2022
- 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 |
|---|---|---|
| K253630 | Mpact 3D Metal FoamLPH · Traditional | 08/28/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | 05/05/2026SE |
| K253940 | M.U.S.T. Pedicle Screw System - ExtensionNKB · Traditional | 04/28/2026SE |
| K253328 | GMK 3D Metal Tibial Tray ExtensionMBH · Traditional | 02/26/2026SE |
| K250644 | MSS - Monobloc stemPHX · Traditional | 02/03/2026SE |
| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | 01/28/2026SE |
| K252847 | NextAR Hip PlatformSBF · Traditional | 01/09/2026SE |
| K242603 | MyPAO SA guidesPBF · Traditional | 11/19/2025SE |
| K250338 | MSS - Humeral reverse liners extensionPHX · Traditional | 10/31/2025SE |
| K250450 | Coated hip implantsLZO · Traditional | 09/19/2025SE |
Questions and answers
When was MectaScrew Extension cleared by the FDA?
MectaScrew Extension (K203335) received a 510(k) decision of Substantially Equivalent on February 3, 2022, 448 days after the submission was received.
What is the product code of K203335?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.