Cleared Traditional

K173329 - jFit Surgical Planner

K173329 is an FDA 510(k) clearance for jFit Surgical Planner, manufactured by Jointvue, LLC. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K173329 · Jointvue, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
23d
Days
Class 2
Risk

K173329 is an FDA 510(k) clearance for the jFit Surgical Planner. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Jointvue, LLC (Knoxville, US). The FDA issued a Cleared decision on November 15, 2017 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Jointvue, LLC devices

FDA 510(k) Submission Details - K173329

510(k) Number K173329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2017
Decision Date November 15, 2017
Days to Decision 23 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 Radiology devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2132
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K173329.
Merge PACS
K173475 · Merge Healthcare Incorporated · Dec 2017
MIM – Y90 Dosimetry
K172218 · Mim Software, Inc. · Nov 2017
syngo®.via protoNeo (Version VA20)
K173378 · Siemens Healthcare GmbH · Nov 2017
Planmeca Romexis
K171385 · Planmeca Oy · Nov 2017
Surgical Planning Software version 1.1
K173247 · Ortho Kinematics, Inc. · Nov 2017
Infinitt PACS 7.0
K172803 · Infinitt Healthcare Co., Ltd. · Oct 2017