Cleared Traditional

K171525 - Intellijoint HIP Generation 2B System

K171525 is an FDA 510(k) clearance for Intellijoint HIP Generation 2B 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 158-day FDA review.

K171525 · Intellijoint Surgical, Inc. · Orthopedic device
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Oct 2017
Decision
158d
Days
Class 2
Risk

K171525 is an FDA 510(k) clearance for the Intellijoint HIP Generation 2B 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 October 30, 2017 after a review of 158 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 - K171525

510(k) Number K171525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2017
Decision Date October 30, 2017
Days to Decision 158 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
36d slower than avg
Panel avg: 122d · This submission: 158d
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 K171525.
NuVasive Navigation Instruments
K172623 · Nu Vasive, Incorporated · Dec 2017
Mako Partial Knee Application
K172301 · Mako Surgical Corp. · Nov 2017
iFuse Implant System- iFuse Navigation
K172268 · SI-BONE, Inc. · Oct 2017
Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap
K172034 · Stryker Corporation · Oct 2017
Mako Total Knee Application
K172219 · Mako Surgical Corp. · Sep 2017
VIPER PRIME navigated inserter
K170937 · Medos International SARL · Sep 2017