Cleared Traditional

K201315 - PERFORM Humeral System – Stem (FDA 510(k) Clearance)

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

K201315 · Tornier, Inc. · Orthopedic device
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Sep 2020
Decision
116d
Days
Class 2
Risk

K201315 is an FDA 510(k) clearance for the PERFORM Humeral System – Stem. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer + Additive, Cemented (product code PAO), Class II - Special Controls.

Submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on September 11, 2020 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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 Tornier, Inc. devices

Submission Details

510(k) Number K201315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2020
Decision Date September 11, 2020
Days to Decision 116 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PAO Prosthesis, Shoulder, Semi-constrained, Metal/polymer + Additive, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Total Shoulders Are Indicated For Arthritis (osteo-, Rheumatoid, Traumatic), Avascular Necrosis, Correction Of Functional Deformity, And Revision Procedures.
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.