Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System
FDA 510(k) K162153 · Ascension Orthopedics
510(k) numberK162153
Submission
- Device name
- Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System
- Applicant
- Ascension Orthopedics
Austin, TX, US - Received
- August 2, 2016
- Decision date
- July 14, 2017
- 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 |
|---|---|---|
| K233674 | Freedom Wrist Arthroplasty SystemJWJ · Traditional | 05/30/2024SE |
| K233670 | Ascension Silicone MCP; Ascension Silicone PIPKYJ · Special | 12/14/2023SE |
| K182878 | Integra Salto Total Ankle SystemHSN · Special | 12/18/2018SE |
| K160830 | Integra External Fixation SystemKTT · Special | 07/06/2016SE |
| K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidKWS · Traditional | 12/23/2015SE |
| K152527 | Integra DigiFuse Cannulated Intramedullary Fusion SystemHWC · Traditional | 10/29/2015SE |
| K151459 | Integra Total Ankle Replacement SystemHSN · Traditional | 08/31/2015SE |
| K142413 | TITAN Modular Total Shoulder SystemKWS · Traditional | 11/14/2014SE |
| K121826 | Integra Proximal Humeral Plate SystemHRS · Traditional | 02/13/2013SE |
| K110700 | Ascension Atlas Humeral Plating SystemHRS · Traditional | 12/06/2011SE |
Questions and answers
When was Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System cleared by the FDA?
Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System (K162153) received a 510(k) decision of Substantially Equivalent on July 14, 2017, 346 days after the submission was received.
What is the product code of K162153?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.