Cleared Traditional

ACCOLADE HFX FEMORAL STEM (K051741) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K051741 · Stryker Orthopaedics · Orthopedic device
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Sep 2005
Decision
90d
Days
Class 2
Risk

K051741 is an FDA 510(k) clearance for the ACCOLADE HFX FEMORAL STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on September 26, 2005 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Orthopaedics devices

Submission Details

510(k) Number K051741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2005
Decision Date September 26, 2005
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 291
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K051741.
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM
K051858 · Exactech, Inc. · Dec 2005
EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
K050398 · Exactech, Inc. · Nov 2005
V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
K052718 · Howmedica Osteonics Corp. · Oct 2005
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
K051682 · Exactech, Inc. · Jul 2005
MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
K051737 · Howmedica Osteonics Corp. · Jul 2005
SECUR-FIT MAX AND PLUS MAX HIP STEMS
K051738 · Howmedica Osteonics Corp. · Jul 2005