Cleared Special

K062383 - UNISYN HA PLASMA MODULAR HIP

K062383 is an FDA 510(k) clearance for UNISYN HA PLASMA MODULAR HIP, 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 128-day FDA review.

K062383 · Hayes Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
128d
Days
Class 2
Risk

K062383 is an FDA 510(k) clearance for the UNISYN HA PLASMA MODULAR HIP. 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 December 21, 2006 after a review of 128 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K062383

510(k) Number K062383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2006
Decision Date December 21, 2006
Days to Decision 128 days
Submission Type Special
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
6d slower than avg
Panel avg: 122d · This submission: 128d
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 80
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K062383.
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K062978 · United Orthopedic Corp. · Jan 2007
EXCIA
K061699 · Aesculap, Inc. · Aug 2006
BETACONE HIP PROSTHESIS SYSTEM
K051826 · Waldemar Link GmbH & Co. KG · Nov 2005
U2 ACETABULAR COMPONENT
K050262 · United Orthopedic Corp. · Aug 2005
K062383 · UNISYN HA PLASMA MODULAR HIP
Download PDF FDA Summary Hayes Medical, Inc.