Product Code: KYJ FDA class 2 21 CFR 888.3230

Prosthesis, Finger, Constrained, Polymer

Orthopedic

The Constrained Polymer Finger Prosthesis is an orthopedic implant made from polymer material with a constrained design used to replace severely damaged or arthritic finger joints, aiming to restore motion and reduce pain in the hand with mechanical stability provided by the implant design. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KYJ, regulated under 21 CFR 888.3230, in the Orthopedic medical specialty. This device is an implant.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: KYJ
Device Class: FDA class 2
Regulation Number: 888.3230
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 14 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K233670	Ascension Silicone MCP; Ascension Silicone PIP	Dec 14, 2023	Substantially Equivalent	Ascension Orthopedics, Inc.
K220142	BRM Digitalis Spacer	Apr 04, 2023	Substantially Equivalent	Brm Extremities Srl
K211385	KeriFlex® MCP and PIP Finger Joint Prostheses	Jul 27, 2022	Substantially Equivalent	Keri Medical SA
K140453	OSTEOTEC SILICONE FINGER IMPLANT	Apr 17, 2015	Substantially Equivalent	Osteotec, Ltd.
K083107	MODIFICATION TO DEPUY NEUFLEX PIP FINGER	Feb 09, 2009	Substantially Equivalent	DePuy Orthopaedics, Inc.
K082231	ASCENSION SILICONE PIP	Jan 12, 2009	Substantially Equivalent	Ascension Orthopedics, Inc.
K022892	ASCENSION SILLICONE MCP	Nov 25, 2002	Substantially Equivalent	Ascension Orthopedics, Inc.
K013629	FINGER JOINT PROSTHESIS	Jan 25, 2002	Substantially Equivalent	Avanta Orthopaedics, Inc.
K001922	DEPUY NEUFLEX PIP FINGER	Aug 29, 2000	Substantially Equivalent	Depuy, Inc.
K970544	DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS	Sep 12, 1997	Substantially Equivalent	Depuy, Inc.
K931588	SUTTER PROXIMAL INTERPHALANGEAL JOINT	Mar 10, 1994	Substantially Equivalent	Sutter Corp.
K870200	SUTTER FINGER JOINT PROSTHESIS	Oct 09, 1987	Substantially Equivalent	Sutter Biomedical, Inc.
K781380	MARNE M.T.P.J. ORTHOPEDIC IMPLANT	Feb 21, 1979	Substantially Equivalent	Farah , Ltd.
K781668	GAMMA RADIATION STERILIZATION PRECEDURE	Nov 03, 1978	Substantially Equivalent	Cutter Laboratories, Inc.