Cleared Traditional

K072271 - STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE

K072271 is an FDA 510(k) clearance for STRYKER NAVIGATION SYSTEM INFINITUS HIP..., manufactured by Stryker Corp.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K072271

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.

HAW Device Classification - Class 2, Special Controls

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 341
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K072271.
LEKSELL SURGIPLAN, MODEL 1006947
K080250 · Elekta Instrument AB · May 2008
ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0
K072899 · Aesculap Implant Systems, Inc. · Feb 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