Cleared Traditional

K000321 - HEMISPHERE MODULAR CUP SYSTEM

K000321 is an FDA 510(k) clearance for HEMISPHERE MODULAR CUP SYSTEM, manufactured by Ortho Development Corp.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K000321 · Ortho Development Corp. · Orthopedic device
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Apr 2000
Decision
68d
Days
Class 2
Risk

K000321 is an FDA 510(k) clearance for the HEMISPHERE MODULAR CUP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on April 10, 2000 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 Ortho Development Corp. devices

FDA 510(k) Submission Details - K000321

510(k) Number K000321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2000
Decision Date April 10, 2000
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 446
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K000321.
REACH FEMORAL COMPONENT
K000760 · Biomet, Inc. · May 2000
KEYSTONE HIP
K000521 · Encore Orthopedics, Inc. · May 2000
MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS
K990830 · Biomet, Inc. · Apr 2000
BICON-PLUS ACETABULAR COMPONENTS
K992154 · Plus Orthopedics · Apr 2000
PINNACLE ACETABULAR SYSTEM
K000306 · DePuy Orthopaedics, Inc. · Mar 2000
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
K000538 · Biomet, Inc. · Mar 2000