Cleared Special

K020989 - SUPER EON PLUS FEMORAL STEMS

K020989 is an FDA 510(k) clearance for SUPER EON PLUS FEMORAL STEMS, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Special 510(k) pathway after a 30-day FDA review.

K020989 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
30d
Days
Class 2
Risk

K020989 is an FDA 510(k) clearance for the SUPER EON PLUS FEMORAL STEMS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on April 26, 2002 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K020989

510(k) Number K020989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2002
Decision Date April 26, 2002
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 564
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K020989.
OSS LES PROXIMAL FEMORAL COMPONENT
K021380 · Biomet, Inc. · May 2002
36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K021310 · Howmedica Osteonics Corp. · May 2002
SL-PLUS LATERALIZED STEM
K021178 · Plus Orthopedics · May 2002
MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)
K020970 · Biomet, Inc. · Apr 2002
EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
K020291 · Exactech, Inc. · Feb 2002
PATRIOT PROTRUSIO CAGE
K020076 · Biomet Orthopedics, Inc. · Jan 2002
K020989 · SUPER EON PLUS FEMORAL STEMS
Download PDF FDA Summary Howmedica Osteonics C…