Cleared Traditional

K992394 - BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT

K992394 is an FDA 510(k) clearance for BUECHEL-PAPPAS HUMERAL HEAD RESURFACING..., manufactured by Endotec, Inc.. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K992394 · Endotec, Inc. · Orthopedic device
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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

FDA 510(k) Submission Details - K992394

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.

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 58
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K992394.
ISS OFFSET HEADS
K003428 · Biomet, Inc. · Nov 2000
SOLAR SHOULDER OFFSET HUMERAL HEAD
K001419 · Howmedica Osteonics Corp. · Jul 2000
ACUMED MODULAR SHOULDER SYSTEM
K992525 · Acu Med, Inc. · Feb 2000
HOWMEDICA HUMERAL INTERCALARY SYSTEM
K984202 · Howmedica, Inc. · Feb 1999
OTI MODULAR SHOULDER SYSTEM
K982886 · Osteoimplant Technology, Inc. · Oct 1998
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
K961260 · Biomet, Inc. · Apr 1997