Cleared Traditional

K954559 - HOWMEDICCA MODULAR PROXIMAL HUMERUS REP...

K954559 is the FDA 510(k) clearance for HOWMEDICCA MODULAR PROXIMAL HUMERUS REP... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HSD) cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K954559 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
284d
Days
Class 2
Risk

K954559 is an FDA 510(k) clearance for the HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on July 12, 1996 after a review of 284 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3690 - 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

Submission Details

510(k) Number K954559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date July 12, 1996
Days to Decision 284 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
162d slower than avg
Panel avg: 122d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3690
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 - HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

All 48
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K954559.
HOWMEDICA HUMERAL INTERCALARY SYSTEM
K984202 · Howmedica, Inc. · Feb 1999
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
K961260 · Biomet, Inc. · Apr 1997
SELECT SHOULDER COCR HUMERAL STEM COMPONENT
K962289 · Intermedics Orthopedics · Aug 1996
INFINITY SHOULDER SYSTEM
K943908 · Wrightmedicaltechnologyinc · May 1995
HEMI-SHOULDER PROSTHESIS
K950594 · Encore Orthopedics, Inc. · May 1995
GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL
K911686 · Depuy, Inc. · Jul 1991