Cleared Traditional

K083558 - MEDACTA TOTAL HIP PROSTHESIS SYSTEM - Q...

K083558 is the FDA 510(k) clearance for MEDACTA TOTAL HIP PROSTHESIS SYSTEM - Q... by Medacta International S.A.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K083558 · Medacta International S.A. · Orthopedic device
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Mar 2009
Decision
94d
Days
Class 2
Risk

K083558 is an FDA 510(k) clearance for the MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Medacta International S.A. (San Diego, US). The FDA issued a Cleared decision on March 6, 2009 after a review of 94 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 Medacta International S.A. devices

Submission Details

510(k) Number K083558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2008
Decision Date March 06, 2009
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
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 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K083558.
MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S
K093944 · Medacta International S.A. · Jan 2010
44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM
K093549 · Biomet Manufacturing Corp · Dec 2009
BIOLOX DELTA CERAMIC FEMORAL HEADS
K083762 · Smith & Nephew, Inc. · Mar 2009
SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM
K082371 · Smith & Nephew, Inc. · Feb 2009
BIOLOX DELTA OPTION CERAMIC HEADS
K082996 · Biomet, Inc. · Jan 2009
NOVATION 12/14 CEMENTED FEMORAL STEMS
K083392 · Exactech, Inc. · Dec 2008