Cleared Traditional

K873601 - AGC UNICOMPARTMENTAL KNEE PROSTHESIS

K873601 is an FDA 510(k) clearance for AGC UNICOMPARTMENTAL KNEE PROSTHESIS, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K873601 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1988
Decision
149d
Days
Class 2
Risk

K873601 is an FDA 510(k) clearance for the AGC UNICOMPARTMENTAL KNEE PROSTHESIS. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 20, 1988 after a review of 149 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K873601

510(k) Number K873601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1987
Decision Date January 20, 1988
Days to Decision 149 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 122d · This submission: 149d
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 K873601.
UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM
K883969 · Intermedics Orthopedics · Apr 1989
KINEMAX TIBIAL WEDGE
K884837 · Howmedica Corp. · Feb 1989
KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM
K882241 · Kirschner Medical Corp. · Jun 1988
WHITESIDE ORTHOLOC (TM)
K864070 · Dow Corning Wright · Jan 1987
ARIZONA CONDYLAR TIBIAL PLATEAU
K862125 · Depuy, Inc. · Jun 1986
MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
K860133 · Depuy, Inc. · Mar 1986