Cleared Traditional

RESPONSE 2000 HIP STEM (K000392) - FDA 510(k) Clearance

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

K000392 · DePuy Orthopaedics, Inc. · Orthopedic device
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Apr 2000
Decision
77d
Days
Class 2
Risk

K000392 is an FDA 510(k) clearance for the RESPONSE 2000 HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 24, 2000 after a review of 77 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 DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K000392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2000
Decision Date April 24, 2000
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 291
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K000392.
ACCOLADE C FEMORAL COMPONENT
K002320 · Howmedica Osteonics Corp. · Sep 2000
FENNING HIP STEM
K002441 · DePuy Orthopaedics, Inc. · Sep 2000
TRIDENT ACETABULAR SHELLS: PS
K001449 · Howmedica Osteonics Corp. · Aug 2000
RESPONSE 2000 CEMENTED HIP STEM
K000432 · DePuy Orthopaedics, Inc. · Apr 2000
PLR SPLINED REVISION STEM
K994184 · Biomet, Inc. · Feb 2000
EXETER CERAMIC FEMORAL HEADS
K993889 · Howmedica Osteonics Corp. · Feb 2000