Cleared Special

K070061 - 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT

K070061 is an FDA 510(k) clearance for 36MM COCR FEMORAL HEAD AND 36MM ACETABU..., manufactured by Hayes Medical, Inc.. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Special 510(k) pathway after a 26-day FDA review.

K070061 · Hayes Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
26d
Days
Class 2
Risk

K070061 is an FDA 510(k) clearance for the 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Hayes Medical, Inc. (El Dorado Hills, US). The FDA issued a Cleared decision on January 31, 2007 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hayes Medical, Inc. devices

FDA 510(k) Submission Details - K070061

510(k) Number K070061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2007
Decision Date January 31, 2007
Days to Decision 26 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 72
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