CAPTIVATE® Compression Screws
FDA 510(k) K222409 · Globus Medical, Inc.
510(k) numberK222409
Submission
- Device name
- CAPTIVATE® Compression Screws
- Applicant
- Globus Medical, Inc.
Audubon, PA, US - Received
- August 10, 2022
- Decision date
- September 8, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K254043 | TRIVANCE Hip StemLPH · Traditional | 08/04/2026SE |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special | 07/31/2026SE |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional | 05/07/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | 04/29/2026SE |
| K261043 | AUTOBAHN Nailing SystemHSB · Special | 04/24/2026SE |
| K252166 | RIB LINK Fixation SystemHRS · Traditional | 02/26/2026SE |
| K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer)OVE · Special | 12/22/2025SE |
| K250599 | ExcelsiusGPS InstrumentsOLO · Traditional | 11/05/2025SE |
| K251161 | ANTHEM® Fracture SystemHRS · Traditional | 08/18/2025SE |
| K241525 | ExcelsiusXRSBF · Traditional | 07/08/2025SE |
Questions and answers
When was CAPTIVATE® Compression Screws cleared by the FDA?
CAPTIVATE® Compression Screws (K222409) received a 510(k) decision of Substantially Equivalent on September 8, 2022, 29 days after the submission was received.
What is the product code of K222409?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.