Finger Joint Prosthesis
FDA 510(k) K013629 · Avanta Orthopaedics, Inc.
510(k) numberK013629
Submission
- Device name
- Finger Joint Prosthesis
- Applicant
- Avanta Orthopaedics, Inc.
San Diego, CA, US - Received
- November 5, 2001
- Decision date
- January 25, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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|---|---|---|---|
| K233670 | Ascension Silicone MCP; Ascension Silicone PIPKYJ · Special | Ascension Orthopedics, Inc. | 12/14/2023SE |
| 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 |
| 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 |
More from Sutter Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K030881 | Avanta Carpal Fusion Plating SystemHRS · Traditional | 04/10/2003SE |
| K021859 | Wrist ImplantJWJ · Traditional | 12/02/2002SE |
| K023604 | Modification to Radial Head ImplantKWI · Special | 11/27/2002SE |
| K011819 | Radial Head ImplantKWI · Special | 06/19/2001SE |
| K010847 | K'FixNDL · Traditional | 06/19/2001SE |
| K003033 | Scaphix, Staple, Fixation, BoneJDR · Traditional | 05/30/2001SE |
| K010786 | Ulnar Head ImplantKXE · Special | 04/11/2001SE |
| K002644 | Radial Head ImplantKWI · Traditional | 11/20/2000SE |
| K990596 | Distal Radius Fracture Fixation Plate SystemHRS · Traditional | 04/29/1999SE |
| K982268 | Ulnar Head ImplantKXE · Traditional | 12/04/1998SE |
Questions and answers
When was Finger Joint Prosthesis cleared by the FDA?
Finger Joint Prosthesis (K013629) received a 510(k) decision of Substantially Equivalent on January 25, 2002, 81 days after the submission was received.
What is the product code of K013629?
The FDA product code is KYJ – Prosthesis, Finger, Constrained, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3230.