Cleared Traditional

K990183 - IMPLEX ALUMINA FEMORAL HEAD

K990183 is the FDA 510(k) clearance for IMPLEX ALUMINA FEMORAL HEAD by Implex Corp.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K990183 · Implex Corp. · Orthopedic device
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Jun 1999
Decision
142d
Days
Class 2
Risk

K990183 is an FDA 510(k) clearance for the IMPLEX ALUMINA FEMORAL HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on June 11, 1999 after a review of 142 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 Implex Corp. devices

Submission Details

510(k) Number K990183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1999
Decision Date June 11, 1999
Days to Decision 142 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
20d slower than avg
Panel avg: 122d · This submission: 142d
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 419
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K990183.
PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)
K990261 · Plus Orthopedics · Aug 1999
ZIRCONIA 22.22MM CERAMIC MODULAR HEADS
K991708 · Biomet, Inc. · Jul 1999
OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS
K991952 · Howmedica Osteonics Corp. · Jun 1999
FOUNDATION POROUS HIP STEM
K991226 · Encore Orthopedics, Inc. · Jun 1999
TYPE 3 FEMORAL COMPONENTS
K983404 · Howmedica Corp. · Dec 1998
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K981847 · Smith & Nephew, Inc. · Jul 1998