Cleared Traditional

K032300 - ACCOLADE-J HIP STEM SERIES

K032300 is the FDA 510(k) clearance for ACCOLADE-J HIP STEM SERIES by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code MEH) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K032300 · Howmedica Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2003
Decision
76d
Days
Class 2
Risk

K032300 is an FDA 510(k) clearance for the ACCOLADE-J HIP STEM SERIES. 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, 2003 after a review of 76 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. 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K032300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2003
Decision Date October 09, 2003
Days to Decision 76 days
Submission Type Traditional
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
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K032300.
SMITH & NEPHEW MODULAR HIP
K042127 · Smith & Nephew, Inc. · Nov 2004
CONTOUR HA COATED RECONSTRUCTION RING
K040680 · Smith & Nephew, Inc. · Jun 2004
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
K040613 · Exactech, Inc. · Jun 2004
ECHELON POROUS PLUS HA HIP STEMS
K023302 · Smith & Nephew, Inc. · Oct 2002
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
K023102 · Howmedica Osteonics Corp. · Oct 2002
HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM
K021403 · Biomet Orthopedics, Inc. · May 2002