Cleared Traditional

K884837 - KINEMAX TIBIAL WEDGE

K884837 is an FDA 510(k) clearance for KINEMAX TIBIAL WEDGE, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K884837 · Howmedica Corp. · Orthopedic device
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Feb 1989
Decision
91d
Days
Class 2
Risk

K884837 is an FDA 510(k) clearance for the KINEMAX TIBIAL WEDGE. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 91 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K884837

510(k) Number K884837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1988
Decision Date February 17, 1989
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 82
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K884837.
WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION
K902538 · Dow Corning Wright · Jul 1990
BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE
K890044 · Biopro, Inc. · Nov 1989
UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM
K883969 · Intermedics Orthopedics · Apr 1989
KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM
K882241 · Kirschner Medical Corp. · Jun 1988
AGC UNICOMPARTMENTAL KNEE PROSTHESIS
K873601 · Biomet, Inc. · Jan 1988
WHITESIDE ORTHOLOC (TM)
K864070 · Dow Corning Wright · Jan 1987