Cleared Traditional

K190660 - G7 Acetabular System Longevity Highly C...

K190660 is the FDA 510(k) clearance for G7 Acetabular System Longevity Highly C... by Zimmer, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K190660 · Zimmer, Inc. · Orthopedic device
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Dec 2019
Decision
266d
Days
Class 2
Risk

K190660 is an FDA 510(k) clearance for the G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular.... 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 December 5, 2019 after a review of 266 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 K190660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2019
Decision Date December 05, 2019
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
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 444
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K190660.
KeYi Total Hip System
K191826 · Beijing Keyi Medical Device Technology Co., Ltd. · May 2020
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K192450 · Precision Casting Solution, LLC · Dec 2019
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K190656 · Zimmer, Inc. · Dec 2019
Pinnacle Duofix HA Acetabular Cup Prosthesis
K192919 · DePuy Orthopaedics, Inc. · Nov 2019
Conformis Hip System
K192198 · Conformis, Inc. · Nov 2019
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K183457 · Zimmer, Inc. · Nov 2019