Cleared Traditional

S-ROM HIP SYSTEM - LOCKING PLUG (K963206) - FDA 510(k) Clearance

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

K963206 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 1996
Decision
62d
Days
Class 2
Risk

K963206 is an FDA 510(k) clearance for the S-ROM HIP SYSTEM - LOCKING PLUG. 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 October 17, 1996 after a review of 62 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K963206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1996
Decision Date October 17, 1996
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
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 K963206.
PERFECTA PLASMA SPRAY HIP STEM
K964218 · Wrightmedicaltechnologyinc · Jan 1997
EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD
K964262 · Exactech, Inc. · Dec 1996
EXACTECH ALL POLY ACETABULAR CUP
K963313 · Exactech, Inc. · Nov 1996
AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM
K961304 · Exactech, Inc. · Oct 1996
SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS
K960984 · Biomet, Inc. · Sep 1996
PERFECTA PS REVISION STEM
K962267 · Wrightmedicaltechnologyinc · Sep 1996