Cleared Traditional

K072704 - UNICOMPARTMENTAL KNEE

K072704 is an FDA 510(k) clearance for UNICOMPARTMENTAL KNEE, manufactured by Valpo Orthopedic Technology, Inc.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K072704 · Valpo Orthopedic Technology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
148d
Days
Class 2
Risk

K072704 is an FDA 510(k) clearance for the UNICOMPARTMENTAL KNEE. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Valpo Orthopedic Technology, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 19, 2008 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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 Valpo Orthopedic Technology, Inc. devices

FDA 510(k) Submission Details - K072704

510(k) Number K072704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2007
Decision Date February 19, 2008
Days to Decision 148 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 122d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRY Device Classification - Class 2, Special Controls

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 80
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K072704.
EVOLUTION UNICONDYLAR KNEE SYSTEM
K100973 · Wrightmedicaltechnologyinc · Aug 2010
STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
K082567 · Howmedica Osteonics Corp. · Oct 2008
UNIVATION UNICONDYLAR KNEE SYSTEM
K081293 · Aesculap Implant Systems, Inc. · Sep 2008
TRIATHLON PKR SYSTEM
K071881 · Howmedica Osteonics Corp. · Oct 2007
DEPUY GCK TIBIAL COMPONENTS
K070267 · DePuy Orthopaedics, Inc. · Aug 2007
TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
K063515 · Biomet Manufacturing, Inc. · Feb 2007