Cleared Traditional

BC Reflex Uni Knee System (K212307) - FDA 510(k) Clearance

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

K212307 · Bodycad Laboratories, Inc. · Orthopedic device
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Oct 2021
Decision
81d
Days
Class 2
Risk

K212307 is an FDA 510(k) clearance for the BC Reflex Uni 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 12, 2021 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bodycad Laboratories, Inc. devices

Submission Details

510(k) Number K212307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2021
Decision Date October 12, 2021
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
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 K212307.
Restoris Multi-Compartmental Knee System
K220930 · Mako Surgical Corp. · Jun 2022
Balanced Knee System Uni
K211471 · Ortho Development Corporation · Dec 2021
MOTOTM Partial Knee & MOTO PFJ Systems Extension
K213071 · Medacta International S.A. · Nov 2021
VISIONAIRE UK Patient Matched Cutting Guides
K211512 · Smith & Nephew, Inc. · Sep 2021
BC Reflex Uni Knee System
K211895 · Bodycad Laboratories, Inc. · Aug 2021
BC Reflex Uni Knee System
K203697 · Bodycad Laboratories, Inc. · Mar 2021