Cleared Traditional

K014070 - EPOCH HIP PROSTHESIS

K014070 is the FDA 510(k) clearance for EPOCH HIP PROSTHESIS by Zimmer, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K014070 · Zimmer, Inc. · Orthopedic device
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Jul 2002
Decision
232d
Days
Class 2
Risk

K014070 is an FDA 510(k) clearance for the EPOCH HIP PROSTHESIS, MODEL 4075 SERIES. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 30, 2002 after a review of 232 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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

Submission Details

510(k) Number K014070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2001
Decision Date July 30, 2002
Days to Decision 232 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
110d slower than avg
Panel avg: 122d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 446
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K014070.
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K021891 · Zimmer, Inc. · Sep 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556 · Smith & Nephew, Inc. · Aug 2002
HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS
K022463 · Biomet Orthopedics, Inc. · Aug 2002
THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #)
K021970 · Implex Corp. · Jul 2002
STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
K021346 · Wrightmedicaltechnologyinc · Jul 2002
TRIDENT CROSSFIRE POLYUETHYLENE LINERS
K021911 · Howmedica Osteonics Corp. · Jul 2002