Cleared Traditional

K882241 - KIRSCHNER UNICONDYLAR-II KNEE SYSTEM

K882241 is an FDA 510(k) clearance for KIRSCHNER UNICONDYLAR-II KNEE SYSTEM, manufactured by Kirschner Medical Corp.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K882241 · Kirschner Medical Corp. · Orthopedic device
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Jun 1988
Decision
33d
Days
Class 2
Risk

K882241 is an FDA 510(k) clearance for the KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on June 29, 1988 after a review of 33 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kirschner Medical Corp. devices

FDA 510(k) Submission Details - K882241

510(k) Number K882241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1988
Decision Date June 29, 1988
Days to Decision 33 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
89d faster than avg
Panel avg: 122d · This submission: 33d
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 K882241.
BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE
K890044 · Biopro, Inc. · Nov 1989
UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM
K883969 · Intermedics Orthopedics · Apr 1989
KINEMAX TIBIAL WEDGE
K884837 · Howmedica Corp. · Feb 1989
AGC UNICOMPARTMENTAL KNEE PROSTHESIS
K873601 · Biomet, Inc. · Jan 1988
WHITESIDE ORTHOLOC (TM)
K864070 · Dow Corning Wright · Jan 1987
ARIZONA CONDYLAR TIBIAL PLATEAU
K862125 · Depuy, Inc. · Jun 1986