Cleared Traditional

K202716 - Ignite Anatomic Shoulder System

K202716 is an FDA 510(k) clearance for Ignite Anatomic Shoulder System, manufactured by Ignite Orthopedics, LLC. The device is a Class 2 Orthopedic device with product code MBF cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K202716 · Ignite Orthopedics, LLC · Orthopedic device
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May 2021
Decision
245d
Days
Class 2
Risk

K202716 is an FDA 510(k) clearance for the Ignite Anatomic Shoulder System. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (product code MBF), Class II - Special Controls.

Submitted by Ignite Orthopedics, LLC (Winona Lake, US). The FDA issued a Cleared decision on May 20, 2021 after a review of 245 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3670 - 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 Ignite Orthopedics, LLC devices

FDA 510(k) Submission Details - K202716

510(k) Number K202716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2020
Decision Date May 20, 2021
Days to Decision 245 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
123d slower than avg
Panel avg: 122d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBF Device Classification - Class 2, Special Controls

Product Code MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3670
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 - MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

All 34
Devices cleared under the same product code (MBF) and FDA review panel - the closest regulatory comparables to K202716.
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