Cleared Traditional

Bodycad Unicompartmental Knee System (K191150) - FDA 510(k) Clearance

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

K191150 · Bodycad Laboratories, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
160d
Days
Class 2
Risk

K191150 is an FDA 510(k) clearance for the Bodycad Unicompartmental Knee System. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Bodycad Laboratories, Inc. (Quebec City, CA). The FDA issued a Cleared decision on October 8, 2019 after a review of 160 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 K191150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2019
Decision Date October 08, 2019
Days to Decision 160 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
38d slower than avg
Panel avg: 122d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 69
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K191150.
Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill
K200151 · Zimmer, Inc. · Mar 2020
iBalance UKA Tibial Tray Implant
K200433 · Arthrex, Inc. · Mar 2020
BC Reflex Uni Knee System
K191996 · Bodycad Laboratories, Inc. · Dec 2019
JOURNEY II Unicompartmental Knee System
K191211 · Smith & Nephew, Inc. · Jul 2019
EMPOWR Partial Knee
K191325 · Encore Medical, L.P. · Jul 2019
Journey II Unicompartmental Knee System
K190085 · Smith & Nephew, Inc. · Feb 2019