Cleared Traditional

Symmetric Total Knee System (K203779) - FDA 510(k) Clearance

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

K203779 · Signal Medical Corporation · Orthopedic device
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Jun 2021
Decision
164d
Days
Class 2
Risk

K203779 is an FDA 510(k) clearance for the Symmetric 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 Signal Medical Corporation (Marysville, US). The FDA issued a Cleared decision on June 10, 2021 after a review of 164 days - an extended review cycle.

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. 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 Signal Medical Corporation devices

Submission Details

510(k) Number K203779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2020
Decision Date June 10, 2021
Days to Decision 164 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
42d slower than avg
Panel avg: 122d · This submission: 164d
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 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 K203779.
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