Cleared Traditional

P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT (K953202) - FDA 510(k) Clearance

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

K953202 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Jan 1996
Decision
205d
Days
Class 2
Risk

K953202 is an FDA 510(k) clearance for the P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on January 31, 1996 after a review of 205 days - an extended review 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: 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K953202 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 10, 1995
Decision Date January 31, 1996
Days to Decision 205 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 122d · This submission: 205d
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 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K953202.
GAMMA SYSTEM
K955473 · Zimmer, Inc. · Feb 1996
ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT
K952859 · Johnson & Johnson Professionals, Inc. · Jan 1996
ULTIMA SIZE 0 CEMENTED FEMORAL STEM
K953200 · Johnson & Johnson Professionals, Inc. · Jan 1996
ALTERNATIVE STERILIZATION PROCESS
K955354 · Howmedica Corp. · Jan 1996
ZCH ALPHA SYSTEM
K954744 · Zimmer, Inc. · Jan 1996
HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM
K952970 · Howmedica Corp. · Jan 1996