Cleared Traditional

K994146 - EPF-PLUS CEMENTLESS PRESS-FIT ACETABULA...

K994146 is an FDA 510(k) clearance for EPF-PLUS CEMENTLESS PRESS-FIT ACETABULA..., manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 369-day FDA review.

K994146 · Plus Orthopedics · Orthopedic device
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Dec 2000
Decision
369d
Days
Class 2
Risk

K994146 is an FDA 510(k) clearance for the EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Plus Orthopedics (Pleasant Hill, US). The FDA issued a Cleared decision on December 11, 2000 after a review of 369 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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. Elevated predicate reliance profile. 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 Plus Orthopedics devices

FDA 510(k) Submission Details - K994146

510(k) Number K994146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1999
Decision Date December 11, 2000
Days to Decision 369 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
247d slower than avg
Panel avg: 122d · This submission: 369d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LWJ Device Classification - Class 2, Special Controls

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 57
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K994146.
PROXILOCK HIP PROSTHESIS
K022966 · Implex Corp. · Oct 2002
TRI-FIT FEMORAL STEM
K010243 · Corin USA · Feb 2001
PRO-FEMUR R
K003016 · Wrightmedicaltechnologyinc · Dec 2000
ACETABULAR PLATES
K002941 · Encore Orthopedics, Inc. · Dec 2000
INTER-OP DURASUL ACETABULAR INSERTS (4MM)
K002575 · Sulzer Orthopedics, Inc. · Nov 2000
MODIFICATION TO PROVIDENT HIP SYSTEM
K002796 · Stelkast Company · Sep 2000