Cleared Traditional

K905580 - TOTAL SHOULDER PROSTHESIS POLYETHYLENE ...

K905580 is an FDA 510(k) clearance for TOTAL SHOULDER PROSTHESIS POLYETHYLENE ..., manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K905580 · Exactech, Inc. · Orthopedic device
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Mar 1991
Decision
90d
Days
Class 2
Risk

K905580 is an FDA 510(k) clearance for the TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on March 12, 1991 after a review of 90 days - within the typical 510(k) review window.

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 Exactech, Inc. devices

FDA 510(k) Submission Details - K905580

510(k) Number K905580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1990
Decision Date March 12, 1991
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 51
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K905580.
ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM
K935593 · Biodynamic Technologies, Inc. · Oct 1994
GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL
K911686 · Depuy, Inc. · Jul 1991
EXACTECH HUMERAL SHOULDER PROSTHESIS
K905577 · Exactech, Inc. · Mar 1991
KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS
K874643 · Kirschner Medical Corp. · Jan 1988
SELECT SHOULDER SYSTEM
K873679 · Intermedics Orthopedics · Nov 1987
KIRSCHNER NEER-III PROXIMAL HUMERUS
K873073 · Kirschner Medical Corp. · Oct 1987