Cleared Traditional

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

K041170 is an FDA 510(k) clearance for SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K041170

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.

LZO Device Classification - Class 2, Special Controls

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 508
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K041170.
CORAIL AMT HIP PROSTHESIS
K042992 · DePuy Orthopaedics, Inc. · Feb 2005
ALUMINA HEAD
K042035 · Fournitures Hospitalieres Industrie · Nov 2004
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
K041443 · Osteoimplant Technology, Inc. · Nov 2004
NOVATION 12/14 PRESS-FIT FEMORAL STEM
K042842 · Exactech, Inc. · Nov 2004
CLS SPOTORNO STEM
K042249 · Zimmer Austin, Inc. · Sep 2004
MODIFICATION TO RESTORATION MODULAR SYSTEM
K040734 · Howmedica Osteonics Corp. · Aug 2004