Cleared Traditional

K954744 - ZCH ALPHA SYSTEM

K954744 is an FDA 510(k) clearance for ZCH ALPHA SYSTEM, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K954744 · Zimmer, Inc. · Orthopedic device
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Jan 1996
Decision
99d
Days
Class 2
Risk

K954744 is an FDA 510(k) clearance for the ZCH ALPHA 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 January 23, 1996 after a review of 99 days - within the typical 510(k) review window.

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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K954744

510(k) Number K954744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1995
Decision Date January 23, 1996
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

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 516
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K954744.
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
ALTERNATIVE STERILIZATION PROCESS
K955354 · Howmedica Corp. · Jan 1996
HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM
K952970 · Howmedica Corp. · Jan 1996
BETA FEMORAL HIP STEM
K945774 · Wrightmedicaltechnologyinc · Dec 1995
APR ACETABULAR INSERTS IOI BIPOLAR
K935585 · Intermedics Orthopedics · Dec 1995