Cleared Traditional

K911982 - BONE NAIL, KUNTSCHER

K911982 is an FDA 510(k) clearance for BONE NAIL, manufactured by International Hospital Supply Co.. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K911982 · International Hospital Supply Co. · Orthopedic device
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Jul 1991
Decision
84d
Days
Class 2
Risk

K911982 is an FDA 510(k) clearance for the BONE NAIL, KUNTSCHER. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by International Hospital Supply Co. (Tarzana, US). The FDA issued a Cleared decision on July 26, 1991 after a review of 84 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 International Hospital Supply Co. devices

FDA 510(k) Submission Details - K911982

510(k) Number K911982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1991
Decision Date July 26, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 122d · This submission: 84d
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 63
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K911982.
HEMI-SHOULDER PROSTHESIS
K950594 · Encore Orthopedics, Inc. · May 1995
ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM
K935593 · Biodynamic Technologies, Inc. · Oct 1994
LIMA RPS SHOULDER
K913282 · Turnkey Intergration USA, Inc. · Oct 1991
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