Cleared Traditional

MODIFICATION TO DEPUY NEUFLEX PIP FINGER (K083107) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K083107 · DePuy Orthopaedics, Inc. · Orthopedic device
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Feb 2009
Decision
112d
Days
Class 2
Risk

K083107 is an FDA 510(k) clearance for the MODIFICATION TO DEPUY NEUFLEX PIP FINGER. Classified as Prosthesis, Finger, Constrained, Polymer (product code KYJ), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 9, 2009 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3230 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K083107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2008
Decision Date February 09, 2009
Days to Decision 112 days
Submission Type Traditional
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
10d faster than avg
Panel avg: 122d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - KYJ Prosthesis, Finger, Constrained, Polymer

Devices cleared under the same product code (KYJ) and FDA review panel - the closest regulatory comparables to K083107.
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
DEPUY NEUFLEX PIP FINGER
K001922 · Depuy, Inc. · Aug 2000
DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS
K970544 · Depuy, Inc. · Sep 1997