Cleared Traditional

K151364 - Intellijoint HIP(tm) System

K151364 is an FDA 510(k) clearance for Intellijoint HIP(tm) System, manufactured by Intellijoint Surgical, Inc.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K151364 · Intellijoint Surgical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
221d
Days
Class 2
Risk

K151364 is an FDA 510(k) clearance for the Intellijoint HIP(tm) System. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Intellijoint Surgical, Inc. (Waterloo, CA). The FDA issued a Cleared decision on December 28, 2015 after a review of 221 days - an extended review cycle.

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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Intellijoint Surgical, Inc. devices

FDA 510(k) Submission Details - K151364

510(k) Number K151364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2015
Decision Date December 28, 2015
Days to Decision 221 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
99d slower than avg
Panel avg: 122d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLO Device Classification - Class 2, Special Controls

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
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 - OLO Orthopedic Stereotaxic Instrument

All 382
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K151364.
Alphatec Navigation Instruments
K153603 · Alphatec Spine, Inc. · Apr 2016
TSolution One w/ACG+ Surgical System
K153647 · THINK Surgical, Inc. · Feb 2016
Navigation Instruments
K153203 · Globus Medical, Inc. · Feb 2016
Navio
K152574 · Blue Belt Technologies, Inc. · Oct 2015
Total Knee Application (TKA)
K143752 · Mako Surgical Corp. · Aug 2015
Navigated Disc Prep Instruments and CAPSTONE Trials
K150231 · Medtronic Sofamor Danek USA, Inc. · Jun 2015