Cleared Traditional

GAMMA SYSTEM (K955473) - FDA 510(k) Clearance

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

K955473 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
78d
Days
Class 2
Risk

K955473 is an FDA 510(k) clearance for the GAMMA SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 16, 1996 after a review of 78 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 Zimmer, Inc. devices

Submission Details

510(k) Number K955473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1995
Decision Date February 16, 1996
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
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 K955473.
COLLARLESS POLISHED TAPER HIP PROSTHESIS
K960658 · Zimmer, Inc. · Jul 1996
DEPUY ENDURANCE CALCAR HIP PROSTHESIS
K961619 · Depuy, Inc. · Jul 1996
OSTEONICS OFFSET HIP STEMS
K954598 · Osteonics Corp. · Apr 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
P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT
K953202 · Johnson & Johnson Professionals, Inc. · Jan 1996