Cleared Traditional

K950312 - ALPHA SYSTEM

K950312 is an FDA 510(k) clearance for 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 111-day FDA review.

K950312 · Zimmer, Inc. · Orthopedic device
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May 1995
Decision
111d
Days
Class 2
Risk

K950312 is an FDA 510(k) clearance for the 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 May 17, 1995 after a review of 111 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 - K950312

510(k) Number K950312 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 26, 1995
Decision Date May 17, 1995
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 K950312.
S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS
K951084 · Joint Medical Products Corp. · May 1995
OSTEONICS(R) CCR HIP STEM SERIES
K945574 · Osteonics Corp. · May 1995
ALL POLYETHYLENE CEMENTED ACETABULAR CUP
K943696 · Depuy, Inc. · May 1995
MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS
K945115 · Biomet, Inc. · May 1995
INDEX ACETABULAT COMPONENT
K950761 · Biomet, Inc. · May 1995
ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE)
K944792 · Zimmer, Inc. · Apr 1995