Ascension Silicone MCP; Ascension Silicone PIP
FDA 510(k) K233670 · Ascension Orthopedics, Inc.
510(k) numberK233670
Submission
- Device name
- Ascension Silicone MCP; Ascension Silicone PIP
- Applicant
- Ascension Orthopedics, Inc.
Austin, TX, US - Received
- November 15, 2023
- Decision date
- December 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KYJ – Prosthesis, Finger, Constrained, Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3230
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KYJ
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|---|---|---|---|
| K220142 | BRM Digitalis SpacerKYJ · Traditional | Brm Extremities Srl | 04/04/2023SE |
| K211385 | KeriFlex® MCP and PIP Finger Joint ProsthesesKYJ · Traditional | Keri Medical SA | 07/27/2022SE |
| K140453 | Osteotec Silicone Finger ImplantKYJ · Traditional | Osteotec, Ltd. | 04/17/2015SE |
| K083107 | Modification to Depuy Neuflex Pip FingerKYJ · Traditional | DePuy Orthopaedics, Inc. | 02/09/2009SE |
| K082231 | Ascension Silicone PipKYJ · Traditional | Ascension Orthopedics, Inc. | 01/12/2009SE |
| K022892 | Ascension Sillicone MCPKYJ · Traditional | Ascension Orthopedics, Inc. | 11/25/2002SE |
| K013629 | Finger Joint ProsthesisKYJ · Traditional | Avanta Orthopaedics, Inc. | 01/25/2002SE |
| K001922 | Depuy Neuflex Pip FingerKYJ · Traditional | Depuy, Inc. | 08/29/2000SE |
| K970544 | Depuy Dupont Orthopaedics Finger Joint ProsthesisKYJ · Traditional | Depuy, Inc. | 09/12/1997SE |
| K931588 | Sutter Proximal Interphalangeal JointKYJ · Traditional | Sutter Corp. | 03/10/1994SE |
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| K162153 | Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation SystemHWC · Traditional | 07/14/2017SE |
| 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 Ascension Silicone MCP; Ascension Silicone PIP cleared by the FDA?
Ascension Silicone MCP; Ascension Silicone PIP (K233670) received a 510(k) decision of Substantially Equivalent on December 14, 2023, 29 days after the submission was received.
What is the product code of K233670?
The FDA product code is KYJ – Prosthesis, Finger, Constrained, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3230.