Cleared Traditional

Balanced Knee System Uni (K211471) - FDA 510(k) Clearance

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

K211471 · Ortho Development Corporation · Orthopedic device
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Dec 2021
Decision
219d
Days
Class 2
Risk

K211471 is an FDA 510(k) clearance for the Balanced Knee System Uni. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on December 16, 2021 after a review of 219 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 Ortho Development Corporation devices

Submission Details

510(k) Number K211471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2021
Decision Date December 16, 2021
Days to Decision 219 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
97d slower than avg
Panel avg: 122d · This submission: 219d
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 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 K211471.
Uni Knee Resurfacing System
K221292 · Overture Resurfacing, Inc. · Mar 2023
TLC Unicompartmental Knee System
K212870 · Signature Orthopaedics Pty, Ltd. · Jun 2022
Restoris Multi-Compartmental Knee System
K220930 · Mako Surgical Corp. · Jun 2022
MOTOTM Partial Knee & MOTO PFJ Systems Extension
K213071 · Medacta International S.A. · Nov 2021
BC Reflex Uni Knee System
K212307 · Bodycad Laboratories, Inc. · Oct 2021
VISIONAIRE UK Patient Matched Cutting Guides
K211512 · Smith & Nephew, Inc. · Sep 2021