Cleared Traditional

K083107 - MODIFICATION TO DEPUY NEUFLEX PIP FINGER

K083107 is an FDA 510(k) clearance for MODIFICATION TO DEPUY NEUFLEX PIP FINGER, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code KYJ cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K083107 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K083107

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.

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 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
GAMMA RADIATION STERILIZATION PRECEDURE
K781668 · Cutter Laboratories, Inc. · Nov 1978