Cleared Traditional

LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP (K920021) - FDA 510(k) Clearance

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

K920021 · Implant Technology, Inc. · Orthopedic device
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Mar 1992
Decision
83d
Days
Class 2
Risk

K920021 is an FDA 510(k) clearance for the LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Implant Technology, Inc. (Secaucus, US). The FDA issued a Cleared decision on March 25, 1992 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Implant Technology, Inc. devices

Submission Details

510(k) Number K920021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1992
Decision Date March 25, 1992
Days to Decision 83 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 282
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K920021.
DEPUY TOTAL HIP BALLS - ION IMPLANTATION
K920286 · Depuy, Inc. · Apr 1992
OSTEONICS MICROSURFACED CDH HIP STEM
K920250 · Stryker Corp. · Apr 1992
BIOMET NTS FEMORAL COMPONENTS
K920161 · Biomet, Inc. · Apr 1992
SOLUTION SYSTEM CUP
K915216 · Depuy, Inc. · Feb 1992
PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP
K911802 · Biomet, Inc. · Jan 1992
BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS
K912712 · Biomet, Inc. · Dec 1991