Cleared Traditional

BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT (K992394) - FDA 510(k) Clearance

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

K992394 · Endotec, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
88d
Days
Class 2
Risk

K992394 is an FDA 510(k) clearance for the BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Endotec, Inc. (South Orange, US). The FDA issued a Cleared decision on October 15, 1999 after a review of 88 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 Endotec, Inc. devices

Submission Details

510(k) Number K992394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1999
Decision Date October 15, 1999
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 K992394.
COPELAND RESURFACING HEADS
K003044 · Biomet, Inc. · Dec 2000
ISS OFFSET HEADS
K003428 · Biomet, Inc. · Nov 2000
SOLAR SHOULDER OFFSET HUMERAL HEAD
K001419 · Howmedica Osteonics Corp. · Jul 2000
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
K961260 · Biomet, Inc. · Apr 1997
HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM
K954559 · Howmedica Corp. · Jul 1996
INFINITY SHOULDER SYSTEM
K943908 · Wrightmedicaltechnologyinc · May 1995