Cleared Traditional

K050766 - EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM

K050766 is an FDA 510(k) clearance for EXPLANT OSTEONECROSIS INTERVENTION IMPL..., manufactured by Zimmer Trabecular. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K050766 · Zimmer Trabecular · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
62d
Days
Class 1
Risk

K050766 is an FDA 510(k) clearance for the EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Zimmer Trabecular (Allendale, US). The FDA issued a Cleared decision on May 26, 2005 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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 Zimmer Trabecular devices

FDA 510(k) Submission Details - K050766

510(k) Number K050766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2005
Decision Date May 26, 2005
Days to Decision 62 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

HWE Device Classification - Class 1, General Controls

Product Code HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

All 51
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K050766.
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
K063688 · The Anspach Effort, Inc. · Jan 2007
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
K043310 · Synthes (Usa) · Jan 2005
AVCORE SYSTEM
K990816 · Modular Cutting Systems, Inc. · Sep 1999
AESCULAP HILAN MOTOR SYSTEM
K973736 · Aesculap, Inc. · Dec 1997
BONE GRAFT HARVESTER
K973560 · Ds Mfg., Inc. · Nov 1997
SURGICAL BURS AND SURGICAL DRILL BITS
K972508 · Synvasive Technology, Inc. · Aug 1997