Cleared Traditional

FINE Osteotomy around the knee (K193614) - FDA 510(k) Clearance

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

K193614 · Bodycad Laboratories, Inc. · Orthopedic device
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Mar 2020
Decision
90d
Days
Class 2
Risk

K193614 is an FDA 510(k) clearance for the FINE Osteotomy around the knee. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Bodycad Laboratories, Inc. (Quebec City, CA). The FDA issued a Cleared decision on March 25, 2020 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Bodycad Laboratories, Inc. devices

Submission Details

510(k) Number K193614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2019
Decision Date March 25, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 Consultant

BioVera, Inc.
Robert A Poggie

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 - HRS Plate, Fixation, Bone

All 697
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K193614.
APTUS® Ankle Trauma System 2.8/3.5
K193633 · Medartis AG · Mar 2020
APTUS® Foot 2.8-3.5 System
K193639 · Medartis AG · Mar 2020
GEO 1st MTP Joint Arthrodesis Plating System
K200108 · Gramercy Extremity Orthopedics, LLC · Mar 2020
Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws
K200043 · Field Orthopaedics Pty, Ltd. · Mar 2020
Park's Pectus System
K191057 · Tdm Co., Ltd. · Mar 2020
ARIX Ankle System
K193616 · Jeil Medical Corporation · Mar 2020