Cleared Traditional

K211471 - Balanced Knee System Uni

K211471 is an FDA 510(k) clearance for Balanced Knee System Uni, manufactured by Ortho Development Corporation. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 219-day FDA review.

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

FDA 510(k) Submission Details - K211471

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.

HSX Device Classification - Class 2, Special Controls

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 103
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