Sutter Proximal Interphalangeal Joint
FDA 510(k) K931588 · Sutter Corp.
510(k) numberK931588
Submission
- Device name
- Sutter Proximal Interphalangeal Joint
- Applicant
- Sutter Corp.
San Diego, CA, US - Received
- March 31, 1993
- Decision date
- March 10, 1994
- 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 |
| 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 |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943354 | Sutter Hammertoe Joint ProsthesisKWH · Traditional | 06/12/1995SE |
| K945221 | Sutter Model 6000 Hand CPM DeviceBXB · Traditional | 02/27/1995SE |
| K924654 | First Metatarsophalangeal Joint Motion SplintBXB · Traditional | 02/22/1993SE |
| K914860 | Sutter Model 10000 Leg CPM DeviceBXB · Traditional | 01/08/1992SE |
| K902707 | Model 9000 at Ankle CPM DeviceBXB · Traditional | 07/25/1990SE |
| K890607 | Sutter Hospital CPMBXB · Traditional | 02/27/1989SE |
Questions and answers
When was Sutter Proximal Interphalangeal Joint cleared by the FDA?
Sutter Proximal Interphalangeal Joint (K931588) received a 510(k) decision of Substantially Equivalent on March 10, 1994, 344 days after the submission was received.
What is the product code of K931588?
The FDA product code is KYJ – Prosthesis, Finger, Constrained, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3230.