Cleared Traditional

K964616 - QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT

K964616 is an FDA 510(k) clearance for QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT, manufactured by Whiteside Biomechanics, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K964616 · Whiteside Biomechanics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 1997
Decision
287d
Days
Class 2
Risk

K964616 is an FDA 510(k) clearance for the QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Whiteside Biomechanics, Inc. (Creve Coeur, US). The FDA issued a Cleared decision on August 7, 1997 after a review of 287 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 Whiteside Biomechanics, Inc. devices

FDA 510(k) Submission Details - K964616

510(k) Number K964616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1996
Decision Date August 07, 1997
Days to Decision 287 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
165d slower than avg
Panel avg: 122d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

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 503
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K964616.
INFINTY DISTAL FEMORAL COMPONENT
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K971718 · Whiteside Biomechanics, Inc. · Jul 1997
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K971429 · Wrightmedicaltechnologyinc · Jul 1997