510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201315Substantially Equivalent

PERFORM Humeral System – Stem

TORNIER Inc., Bloomington MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201315 is the FDA 510(k) clearance record for PERFORM Humeral System – Stem, a class II device, cleared for Tornier, Inc. on under FDA product code PAO (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented). FDA's definition for product code PAO reads: "Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures". FDA records list 140 510(k) clearances for Tornier, Inc., from to . As of , FDA records show one recall naming K201315.

Clearance record

Decision date
Received
(116 days to decision)
Product code
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
Regulation
21 CFR 888.3660
Device class
Class II
Review panel
Orthopedic
Applicant
Tornier, Inc. 10801 Nesbitt Ave. S., Bloomington MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PAO

Trailing 12 months

FDA records hold no clearances under product code PAO in the trailing twelve months.

FDA records show no clearances under product code PAO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PAO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260