Cleared Traditional

K072271 - STRYKER NAVIGATION SYSTEM INFINITUS HIP...

K072271 is the FDA 510(k) clearance for STRYKER NAVIGATION SYSTEM INFINITUS HIP... by Stryker Corp.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K072271 · Stryker Corp. · Neurology device
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Dec 2007
Decision
125d
Days
Class 2
Risk

K072271 is an FDA 510(k) clearance for the STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on December 18, 2007 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Corp. devices

Submission Details

510(k) Number K072271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2007
Decision Date December 18, 2007
Days to Decision 125 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 148d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 225
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K072271.
UNI-KNEE 2.0
K080678 · Brainlab AG · Jun 2008
LEKSELL SURGIPLAN, MODEL 1006947
K080250 · Elekta Instrument AB · May 2008
MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)
K072806 · Mako Surgical Corp. · Jan 2008
VECTOR VISION HIP
K072716 · Brainlab AG · Oct 2007
VECTORVISION HIP AND HIP SR
K072573 · Brainlab AG · Oct 2007
BRAINSUITE NET
K070556 · Brainlab AG · Sep 2007