Cleared Special

K023102 - ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM

K023102 is the FDA 510(k) clearance for ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code MEH) cleared through the Special 510(k) pathway after a 21-day FDA review.

K023102 · Howmedica Osteonics Corp. · Orthopedic device
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Oct 2002
Decision
21d
Days
Class 2
Risk

K023102 is an FDA 510(k) clearance for the ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on October 9, 2002 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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.

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K023102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2002
Decision Date October 09, 2002
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 130
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K023102.
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
K040613 · Exactech, Inc. · Jun 2004
ACCOLADE-J HIP STEM SERIES
K032300 · Howmedica Osteonics Corp. · Oct 2003
ECHELON POROUS PLUS HA HIP STEMS
K023302 · Smith & Nephew, Inc. · Oct 2002
HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM
K021403 · Biomet Orthopedics, Inc. · May 2002
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
K020615 · Howmedica Osteonics Corp. · May 2002
TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM
K020963 · Biomet Orthopedics, Inc. · Apr 2002