Cleared Traditional

The Optimotion Blue Total Knee System (K191084) - FDA 510(k) Clearance

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

K191084 · Optimotion Implants, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
349d
Days
Class 2
Risk

K191084 is an FDA 510(k) clearance for the The Optimotion Blue Total Knee System. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Optimotion Implants, LLC (Winter Park, US). The FDA issued a Cleared decision on April 7, 2020 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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. Elevated predicate reliance profile. 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 Optimotion Implants, LLC devices

Submission Details

510(k) Number K191084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2019
Decision Date April 07, 2020
Days to Decision 349 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
227d slower than avg
Panel avg: 122d · This submission: 349d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 108
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K191084.
UNIKO PointCloud™ Knee Instruments
K193312 · Unik Orthopedics, Inc. · Aug 2020
LINK TrabecuLink Femoral Cones
K201364 · Waldemar Link GmbH & Co. KG · Jul 2020
Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
K200782 · Howmedica Osteonics Corp. · May 2020
LINK TrabecuLink Tibial Cones
K200113 · Waldemar Link GmbH & Co. KG · Mar 2020
Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
K190991 · Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) · Aug 2019
TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
K182346 · Exactech, Inc. · Nov 2018