Tornier Perform Humeral System Stemless
FDA 510(k) K220418 · Tornier, Inc.
510(k) numberK220418
Submission
- Device name
- Tornier Perform Humeral System Stemless
- Applicant
- Tornier, Inc.
Bloomington, MN, US - Received
- February 14, 2022
- Decision date
- September 14, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PKC – Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
Replacement of the humeral head for total anatomic shoulder arthroplasty
Other 510(k)s with product code PKC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254154 | FX V135 EASYTECH® Shoulder SystemPKC · Traditional | FX Shoulder Solutions, Inc. | 05/01/2026SE |
| K252129 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | Smith & Nephew, Inc. | 10/03/2025SE |
| K243248 | Inhance IntactPKC · Traditional | Depuy Ireland UC | 12/23/2024SE |
| K241873 | OsseoFit Stemless Shoulder SystemPKC · Traditional | Zimmer, Inc. | 12/11/2024SE |
| K240716 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | Smith & Nephew, Inc. | 11/20/2024SE |
| K221758 | SMR Stemless AnatomicPKC · Traditional | Lima Corporate S.P.A. | 03/17/2023SE |
| K213615 | Shoulder Innovations Total Shoulder SystemPKC · Traditional | Shoulder Innovations, Inc. | 03/11/2022SE |
| K212683 | GLOBAL ICON Stemless Shoulder SystemPKC · Traditional | Depuy(Ireland) | 01/19/2022SE |
| K203108 | Ignite Stemless Anatomic Shoulder SystemPKC · Traditional | Ignite Orthopedics, LLC | 07/16/2021SE |
| K201391 | Easytech® Anatomical Shoulder SystemPKC · Traditional | Fx Shoulder USA, Inc. | 02/16/2021SE |
More from Fx Shoulder USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260721 | Tornier Perform Advanced GlenoidKWS · Traditional | 07/22/2026SE |
| K252788 | Tornier Perform Reversed Monopost Glenoid (Perform Mono)PHX · Traditional | 01/08/2026SE |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT · Traditional | 10/30/2025SE |
| K230352 | Tornier Humeral Nail and Tornier Long Humeral NailHSB · Traditional | 10/31/2023SE |
| K220914 | Tornier Perform Humeral System FracturePHX · Traditional | 10/14/2022SE |
| K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient…PHX · Traditional | 11/12/2021SE |
| K213124 | Tomier Perform Reversed Glenoid Cannulated GlenospheresPHX · Special | 10/26/2021SE |
| K201315 | PERFORM Humeral System StemPAO · Traditional | 09/11/2020SE |
| K193247 | LATITUDE EV Total Elbow ArthroplastyJDB · Traditional | 08/05/2020SE |
| K191711 | ORTHOLOC SPS Shoulder Plating SystemHRS · Special | 07/17/2019SE |
Questions and answers
When was Tornier Perform Humeral System Stemless cleared by the FDA?
Tornier Perform Humeral System Stemless (K220418) received a 510(k) decision of Substantially Equivalent on September 14, 2022, 212 days after the submission was received.
What is the product code of K220418?
The FDA product code is PKC – Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained, a Class II (moderate risk) device regulated under 21 CFR 888.3660.