Cleared Special

K022555 - ACCOLADE C FEMORAL STEMS

K022555 is the FDA 510(k) clearance for ACCOLADE C FEMORAL STEMS by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Special 510(k) pathway after a 24-day FDA review.

K022555 · Howmedica Osteonics Corp. · Orthopedic device
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Aug 2002
Decision
24d
Days
Class 2
Risk

K022555 is an FDA 510(k) clearance for the ACCOLADE C FEMORAL STEMS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 26, 2002 after a review of 24 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 K022555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2002
Decision Date August 26, 2002
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 433
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K022555.
ASCENDENT ACETABULAR SYSTEM
K022985 · Sulzer Orthopedics, Inc. · Dec 2002
GMRS PRESS FIT STEMS WITH PUREFIX HA
K022403 · Howmedica Osteonics Corp. · Oct 2002
RESTORATION MODULAR SYSTEM
K022549 · Howmedica Osteonics Corp. · Sep 2002
MPF ACETABULAR CUP GENERATION 2
K022120 · Plus Orthopedics · Jul 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673 · Smith & Nephew, Inc. · Jun 2002
MS-30 LATERAL FEMORAL STEM
K020713 · Sulzer Orthopedics, Inc. · May 2002