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FDA 510(k)

KeriFlex® MCP and PIP Finger Joint Prostheses

K-Number: K211385 · 2022-07-27

ApplicantKeri Medical SA
Decision Date2022-07-27
Product CodeKYJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KeriFlex® MCP and PIP Finger Joint Prostheses is a medical device manufactured by Keri Medical SA. It received FDA 510(k) clearance on 2022-07-27 under approval number K211385. The device is classified under product code KYJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KeriFlex® MCP and PIP Finger Joint Prostheses?

KeriFlex® MCP and PIP Finger Joint Prostheses is a medical device that received FDA 510(k) clearance on 2022-07-27. It is manufactured by Keri Medical SA. The 510(k) number is K211385.

When was KeriFlex® MCP and PIP Finger Joint Prostheses approved by the FDA?

KeriFlex® MCP and PIP Finger Joint Prostheses received FDA 510(k) clearance on 2022-07-27, under approval number K211385.

What company makes KeriFlex® MCP and PIP Finger Joint Prostheses?

KeriFlex® MCP and PIP Finger Joint Prostheses is manufactured by Keri Medical SA.

What is the FDA product code for KeriFlex® MCP and PIP Finger Joint Prostheses?

The FDA product code for KeriFlex® MCP and PIP Finger Joint Prostheses is KYJ.

Related Clinical Trials

NCT07598695 Sensory Feedback and Hand Motor Adaptation RECRUITING NCT02244788 Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint AVAILABLE NCT07573189 The Effects of Recovery Compression Boots on Blood Lactate Levels, Functional Movement, and Joint Ange of Motion in Collegiate Athletes. ACTIVE_NOT_RECRUITING NCT07559747 Repetitive Peripheral Magnetic Stimulation Enhances Modified Constraint-Induced Movement Therapy Outcomes After Stroke COMPLETED NCT07544264 Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40619298 Software-based finger joint range of motion analysis: Current concepts, considerations, and challenges. Journal of hand therapy : official journal of the American Society of Hand Therapists (2025)

Other Devices by Keri Medical SA

PMA P240020Prosthesis, finger, semi-constrained, metal/polymer

Related Devices (Code: KYJ)

K233670Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc. K220142BRM Digitalis SpacerBrm Extremities Srl

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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