Cleared Traditional

K873679 - SELECT SHOULDER SYSTEM

K873679 is an FDA 510(k) clearance for SELECT SHOULDER SYSTEM, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K873679 · Intermedics Orthopedics · Orthopedic device
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Nov 1987
Decision
64d
Days
Class 2
Risk

K873679 is an FDA 510(k) clearance for the SELECT SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on November 17, 1987 after a review of 64 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K873679

510(k) Number K873679 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 14, 1987
Decision Date November 17, 1987
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
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 K873679.
EXACTECH HUMERAL SHOULDER PROSTHESIS
K905577 · Exactech, Inc. · Mar 1991
TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO
K905580 · Exactech, Inc. · Mar 1991
KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS
K874643 · Kirschner Medical Corp. · Jan 1988
KIRSCHNER NEER-III PROXIMAL HUMERUS
K873073 · Kirschner Medical Corp. · Oct 1987
101 NEER TYPE SHOULDER
K822771 · Intermedics Orthopedics · Oct 1982
MONOSPHERICAL SHOULDER PROSTHESIS
K802123 · Howmedica Corp. · Sep 1980