Cleared Traditional

K093491 - HIP SEXTANT INSTRUMENT SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093491 · Surgical Planning Associates · Orthopedic device
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Dec 2010
Decision
394d
Days
Class 2
Risk

K093491 is an FDA 510(k) clearance for the HIP SEXTANT INSTRUMENT SYSTEM. Classified as Patient Specific Manual Orthopedic Stereotaxic System (product code OSF), Class II - Special Controls.

Submitted by Surgical Planning Associates (Medford, US). The FDA issued a Cleared decision on December 9, 2010 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K093491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2009
Decision Date December 09, 2010
Days to Decision 394 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
272d slower than avg
Panel avg: 122d · This submission: 394d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OSF Patient Specific Manual Orthopedic Stereotaxic System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Intended For Defining Orthopedic Acetabular Implant Alignment Relative To A Patient's Anatomy.
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.