Cleared Traditional

K873970 - KIRSCHNER UNICONDYLAR KNEE SYSTEM

K873970 is an FDA 510(k) clearance for KIRSCHNER UNICONDYLAR KNEE SYSTEM, manufactured by Kirschner Medical Corp.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K873970 · Kirschner Medical Corp. · Orthopedic device
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Dec 1987
Decision
93d
Days
Class 2
Risk

K873970 is an FDA 510(k) clearance for the KIRSCHNER UNICONDYLAR KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on December 31, 1987 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 Kirschner Medical Corp. devices

FDA 510(k) Submission Details - K873970

510(k) Number K873970 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 29, 1987
Decision Date December 31, 1987
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSX Device Classification - Class 2, Special Controls

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 101
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K873970.
KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM
K894068 · Kirschner Medical Corp. · Dec 1989
WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM
K881779 · Dow Corning Wright · Aug 1988
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE
K880155 · Zimmer, Inc. · Aug 1988
HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.
K872735 · Howmedica Corp. · Aug 1987
INSALL/BURSTEIN(TM)* II TIBIAL WEDGES
K862632 · Zimmer, Inc. · Mar 1987
OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM
K862837 · Osteonics Corp. · Dec 1986