Cleared Traditional

101 NEER TYPE SHOULDER (K822771) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K822771 · Intermedics Orthopedics · Orthopedic device
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Oct 1982
Decision
22d
Days
Class 2
Risk

K822771 is an FDA 510(k) clearance for the 101 NEER TYPE SHOULDER. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Mchenry, US). The FDA issued a Cleared decision on October 6, 1982 after a review of 22 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

Submission Details

510(k) Number K822771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1982
Decision Date October 06, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 122d · This submission: 22d
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 33
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K822771.
GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL
K911686 · Depuy, Inc. · Jul 1991
EXACTECH HUMERAL SHOULDER PROSTHESIS
K905577 · Exactech, Inc. · Mar 1991
TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO
K905580 · Exactech, Inc. · Mar 1991
MONOSPHERICAL SHOULDER PROSTHESIS
K802123 · Howmedica Corp. · Sep 1980
NEW JERSEY HEMIARTHROPLASTY SHOLDER PROS
K800494 · Depuy, Inc. · Mar 1980