Cleared Traditional

K954559 - HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM

K954559 is an FDA 510(k) clearance for HOWMEDICCA MODULAR PROXIMAL HUMERUS REP..., manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K954559

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.

HSD Device Classification - Class 2, Special Controls

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 62
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K954559.
OTI MODULAR SHOULDER SYSTEM
K982886 · Osteoimplant Technology, Inc. · Oct 1998
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
ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM
K935593 · Biodynamic Technologies, Inc. · Oct 1994