Cleared Traditional

K041170 - SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS

K041170 is the FDA 510(k) clearance for SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K041170 · Howmedica Osteonics Corp. · Orthopedic device
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Nov 2004
Decision
189d
Days
Class 2
Risk

K041170 is an FDA 510(k) clearance for the SECUR-FIT HA AND SECUR-FIT PLUS HIP 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. (Mahwah, US). The FDA issued a Cleared decision on November 9, 2004 after a review of 189 days - an extended review 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: 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K041170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2004
Decision Date November 09, 2004
Days to Decision 189 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
67d slower than avg
Panel avg: 122d · This submission: 189d
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 433
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K041170.
BIOLOX DELTA CERAMIC HEADS
K042091 · Biomet, Inc. · Mar 2005
HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS
K041940 · Howmedica Osteonics Corp. · Feb 2005
CORAIL AMT HIP PROSTHESIS
K042992 · DePuy Orthopaedics, Inc. · Feb 2005
NOVATION 12/14 PRESS-FIT FEMORAL STEM
K042842 · Exactech, Inc. · Nov 2004
MODIFICATION TO RESTORATION MODULAR SYSTEM
K040734 · Howmedica Osteonics Corp. · Aug 2004
MS-30 FEMORAL STEM STANDARD AND LATERAL
K040803 · Zimmer, Inc. · Apr 2004