Accin Bipolar Head System
FDA 510(k) K080647 · Accelerated Innovation, LLC
510(k) numberK080647
Submission
- Device name
- Accin Bipolar Head System
- Applicant
- Accelerated Innovation, LLC
Clifton, NJ, US - Received
- March 7, 2008
- Decision date
- July 8, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3390
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253357 | b-ONE® Bipolar HeadKWY · Traditional | B-One Ortho, Corp. | 04/13/2026SE |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip)KWY · Traditional | Maxx Orthopedics, Inc. | 08/25/2025SE |
| K231526 | CORAIL Cemented Femoral StemKWY · Traditional | Depuy Ireland UC | 12/19/2023SE |
| K223441 | SpaceFlex Acetabular CupKWY · Traditional | G21, S.R.L. | 03/23/2023SE |
| K221794 | Vario-Cup SystemKWY · Special | Waldemar Link GmbH & Co. KG | 07/20/2022SE |
| K220492 | COPAL exchange G hip spacerKWY · Special | Heraeus Medical GmbH | 03/23/2022SE |
| K200709 | Kyocera Bipolar Hip SystemKWY · Special | Kyocera Medical Technologies, Inc. | 04/17/2020SE |
| K192236 | Fitmore Hip StemKWY · Special | Zimmer GmbH | 11/05/2019SE |
| K191016 | COPAL exchange G Hip and Knee SpacersKWY · Traditional | Heraeus Medical GmbH | 11/01/2019SE |
| K191297 | iNSitu Bipolar Hip SystemKWY · Traditional | Theken Companies, LLC | 09/17/2019SE |
More from Theken Companies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K081127 | Accin Total Knee SystemJWH · Traditional | 10/17/2008SE |
| K080539 | Accin Unipolar Head SystemJDI · Traditional | 06/02/2008SE |
| K073120 | Accin Patellofemoral SystemKRR · Traditional | 02/29/2008SE |
| K073531 | Accin Pedicle Screw SystemMNH · Traditional | 02/04/2008SE |
| K073530 | Accin Anterior Cervical Plate SystemKWQ · Traditional | 01/31/2008SE |
| K073068 | Accin Hip SystemLPH · Traditional | 01/10/2008SE |
Questions and answers
When was Accin Bipolar Head System cleared by the FDA?
Accin Bipolar Head System (K080647) received a 510(k) decision of Substantially Equivalent on July 8, 2008, 123 days after the submission was received.
What is the product code of K080647?
The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.