Cleared Special

K063822 - MODIFICATION TO HIPSTAR FEMORAL STEM

K063822 is an FDA 510(k) clearance for MODIFICATION TO HIPSTAR FEMORAL STEM, manufactured by Stryker Orthopaedics. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 30-day FDA review.

K063822 · Stryker Orthopaedics · Orthopedic device
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Jan 2007
Decision
30d
Days
Class 2
Risk

K063822 is an FDA 510(k) clearance for the MODIFICATION TO HIPSTAR FEMORAL STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on January 25, 2007 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 Stryker Orthopaedics devices

FDA 510(k) Submission Details - K063822

510(k) Number K063822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2006
Decision Date January 25, 2007
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 453
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K063822.
DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS
K071784 · DePuy Orthopaedics, Inc. · Jul 2007
VITALITY HIP SYSTEM MODEL#420
K070050 · Encore Medical, L.P. · May 2007
REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
K070369 · Biomet, Inc. · Mar 2007
EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM
K062775 · Ortho Development Corp. · Jan 2007
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05
K061461 · Zimmer, Inc. · Dec 2006
FMP COATED SPIKED ACETABULAR CUP
K063257 · Encore Medical, L.P. · Nov 2006