Cleared Traditional

K950418 - ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)

K950418 is an FDA 510(k) clearance for ALPHA POROUS COATED FEMORAL COMPONENT (..., manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K950418 · Wrightmedicaltechnologyinc · Orthopedic device
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Jun 1995
Decision
135d
Days
Class 2
Risk

K950418 is an FDA 510(k) clearance for the ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL). Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on June 15, 1995 after a review of 135 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K950418

510(k) Number K950418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1995
Decision Date June 15, 1995
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
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 K950418.
FOUNDATION POROUS STEM
K935263 · Encore Orthopedics, Inc. · Jul 1995
ENDO PROSTHESIS FEMORAL HEAD
K952461 · Stelkast Company · Jun 1995
S-ROM ZTP UHMWPE ACETABULAR CUP
K951726 · Joint Medical Products Corp. · Jun 1995
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