Cleared Traditional

K201315 - PERFORM Humeral System – Stem

K201315 is an FDA 510(k) clearance for PERFORM Humeral System – Stem, manufactured by Tornier, Inc.. The device is a Class 2 Orthopedic device with product code PAO cleared through the Traditional 510(k) pathway after a 116-day FDA review.

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

FDA 510(k) Submission Details - K201315

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
Combination Product No
PCCP Authorized No
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.

PAO Device Classification - Class 2, Special Controls

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.