Cleared Traditional

K982859 - UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM

K982859 is an FDA 510(k) clearance for UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM, manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K982859 · Plus Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
351d
Days
Class 2
Risk

K982859 is an FDA 510(k) clearance for the UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Plus Orthopedics (San Diego, US). The FDA issued a Cleared decision on July 30, 1999 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Plus Orthopedics devices

FDA 510(k) Submission Details - K982859

510(k) Number K982859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1998
Decision Date July 30, 1999
Days to Decision 351 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
229d slower than avg
Panel avg: 122d · This submission: 351d
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 75
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K982859.
MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
K001451 · DePuy Orthopaedics, Inc. · May 2000
OSTEONICS SERIES 7000 AD TIBIAL TRAY
K983657 · Osteonics Corp. · Apr 2000
DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
K000172 · DePuy Orthopaedics, Inc. · Feb 2000
REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
K980665 · Biomet, Inc. · May 1998
OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS
K974434 · Osteonics Corp. · Jan 1998
REPICCI II UNICONDYLAR KNEE
K971938 · Biomet, Inc. · Aug 1997