Cleared Traditional

K012800 - SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM

K012800 is an FDA 510(k) clearance for SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM, manufactured by Whiteside Biomechanics, Inc.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K012800 · Whiteside Biomechanics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
255d
Days
Class 2
Risk

K012800 is an FDA 510(k) clearance for the SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Whiteside Biomechanics, Inc. (Creve Coeur, US). The FDA issued a Cleared decision on May 3, 2002 after a review of 255 days - an extended review cycle.

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 Whiteside Biomechanics, Inc. devices

FDA 510(k) Submission Details - K012800

510(k) Number K012800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2001
Decision Date May 03, 2002
Days to Decision 255 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
133d slower than avg
Panel avg: 122d · This submission: 255d
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 K012800.
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REPICCI II UNICONDYLAR KNEE SYSTEM
K020264 · Biomet Orthopedics, Inc. · Feb 2002
MJS POSTERIOR STABILIZED KNEE SYSTEM
K012762 · Osteoimplant Technology, Inc. · Dec 2001