Cleared Traditional

K003316 - OTI CERAMIC FEMORAL HEAD SYSTEM

K003316 is an FDA 510(k) clearance for OTI CERAMIC FEMORAL HEAD SYSTEM, manufactured by Osteoimplant Technology, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K003316 · Osteoimplant Technology, Inc. · Orthopedic device
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Jan 2001
Decision
88d
Days
Class 2
Risk

K003316 is an FDA 510(k) clearance for the OTI CERAMIC FEMORAL HEAD SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Osteoimplant Technology, Inc. (Hunt Valley, US). The FDA issued a Cleared decision on January 19, 2001 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osteoimplant Technology, Inc. devices

FDA 510(k) Submission Details - K003316

510(k) Number K003316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2000
Decision Date January 19, 2001
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
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 476
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K003316.
CLS VARUS STEM/CLS 135 STEM
K010839 · Sulzer Orthopedics, Inc. · Apr 2001
LPC-PLUS ACETABULAR CUP
K003274 · Plus Orthopedics · Apr 2001
PORTRAIT FEMORAL COMPONENT
K010560 · Biomet, Inc. · Mar 2001
V-40/C-TAPER ADAPTER SLEEVE
K003379 · Howmedica Osteonics Corp. · Nov 2000
OSTEONICS ALUMINA C-TAPER HEAD
K003391 · Howmedica Osteonics Corp. · Nov 2000
ALUMINA V40 HEAD
K003413 · Howmedica Osteonics Corp. · Nov 2000