Cleared Traditional

K001419 - SOLAR SHOULDER OFFSET HUMERAL HEAD

K001419 is an FDA 510(k) clearance for SOLAR SHOULDER OFFSET HUMERAL HEAD, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K001419 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
83d
Days
Class 2
Risk

K001419 is an FDA 510(k) clearance for the SOLAR SHOULDER OFFSET HUMERAL HEAD. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on July 27, 2000 after a review of 83 days - a notably fast clearance 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: 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 Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K001419

510(k) Number K001419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2000
Decision Date July 27, 2000
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 64
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K001419.
COPELAND RESURFACING HUMERAL HEADS
K010664 · Biomet Manufacturing, Inc. · Apr 2001
COPELAND RESURFACING HEADS
K003044 · Biomet, Inc. · Dec 2000
ISS OFFSET HEADS
K003428 · Biomet, Inc. · Nov 2000
ACUMED MODULAR SHOULDER SYSTEM
K992525 · Acu Med, Inc. · Feb 2000
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
K992394 · Endotec, Inc. · Oct 1999
HOWMEDICA HUMERAL INTERCALARY SYSTEM
K984202 · Howmedica, Inc. · Feb 1999