Cleared Special

K263582 - KeriFlex® MCP and PIP Finger Joint Prostheses

K263582 is an FDA 510(k) clearance for KeriFlex MCP and PIP Finger Joint Prost..., manufactured by Keri Medical SA. The device is a Class 2 Orthopedic device with product code KYJ cleared through the Special 510(k) pathway after a 29-day FDA review.

K263582 · Keri Medical SA · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
29d
Days
Class 2
Risk

K263582 is an FDA 510(k) clearance for the KeriFlex® MCP and PIP Finger Joint Prostheses. Classified as Prosthesis, Finger, Constrained, Polymer (product code KYJ), Class II - Special Controls.

Submitted by Keri Medical SA (Plan-Les-Ouates, CH). The FDA issued a Cleared decision on October 29, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3230 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K263582

510(k) Number K263582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2026
Decision Date October 29, 2026
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

KYJ Device Classification - Class 2, Special Controls

Product Code KYJ Prosthesis, Finger, Constrained, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3230
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

MCRA, LLC
Sarah Pleaugh

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KYJ Prosthesis, Finger, Constrained, Polymer

All 14
Devices cleared under the same product code (KYJ) and FDA review panel - the closest regulatory comparables to K263582.
Ascension Silicone MCP
K233670 · Ascension Orthopedics, Inc. · Dec 2023
BRM Digitalis Spacer
K220142 · Brm Extremities Srl · Apr 2023
KeriFlex® MCP and PIP Finger Joint Prostheses
K211385 · Keri Medical SA · Jul 2022
OSTEOTEC SILICONE FINGER IMPLANT
K140453 · Osteotec, Ltd. · Apr 2015
MODIFICATION TO DEPUY NEUFLEX PIP FINGER
K083107 · DePuy Orthopaedics, Inc. · Feb 2009
ASCENSION SILICONE PIP
K082231 · Ascension Orthopedics, Inc. · Jan 2009
K263582 · KeriFlex® MCP and PIP Finger Joint Prostheses
Download PDF FDA Summary Keri Medical SA