Cleared Traditional

K192450 - Precision Casting Solutions Total Hip S...

K192450 is the FDA 510(k) clearance for Precision Casting Solutions Total Hip S... by Precision Casting Solution, LLC. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K192450 · Precision Casting Solution, LLC · Orthopedic device
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Dec 2019
Decision
102d
Days
Class 2
Risk

K192450 is an FDA 510(k) clearance for the Precision Casting Solutions Total Hip System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Precision Casting Solution, LLC (Oregon City, US). The FDA issued a Cleared decision on December 17, 2019 after a review of 102 days - within the typical 510(k) review window.

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 Precision Casting Solution, LLC devices

Submission Details

510(k) Number K192450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2019
Decision Date December 17, 2019
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
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 428
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K192450.
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KeYi Total Hip System
K191826 · Beijing Keyi Medical Device Technology Co., Ltd. · May 2020
Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
K190656 · Zimmer, Inc. · Dec 2019
G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene
K190660 · Zimmer, Inc. · Dec 2019
Pinnacle Duofix HA Acetabular Cup Prosthesis
K192919 · DePuy Orthopaedics, Inc. · Nov 2019