Cleared Traditional

PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) (K990261) - FDA 510(k) Clearance

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

K990261 · Plus Orthopedics · Orthopedic device
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Aug 1999
Decision
212d
Days
Class 2
Risk

K990261 is an FDA 510(k) clearance for the PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA). Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Plus Orthopedics (San Diego, US). The FDA issued a Cleared decision on August 27, 1999 after a review of 212 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 Plus Orthopedics devices

Submission Details

510(k) Number K990261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1999
Decision Date August 27, 1999
Days to Decision 212 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
90d slower than avg
Panel avg: 122d · This submission: 212d
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 292
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K990261.
PLR SPLINED REVISION STEM
K994184 · Biomet, Inc. · Feb 2000
EXETER CERAMIC FEMORAL HEADS
K993889 · Howmedica Osteonics Corp. · Feb 2000
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K991162 · Smith & Nephew, Inc. · Jan 2000
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
TYPE 3 FEMORAL COMPONENTS
K983404 · Howmedica Corp. · Dec 1998