# K260721: Tornier Perform Advanced Glenoid

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Jul 22, 2026 after 139 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K911686 (1991). 210 ancestors in all.
No later device cites it as a predicate yet.
1 of 211 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160975: Aequalis PerFORM+ Shoulder System, Tornier, Inc. (2016) Summary page 5.
- K111902: Aequalis Shoulder System, Tornier (2011) Summary page 5.
- K201315: PERFORM Humeral System – Stem, Tornier, Inc. (2020) Summary page 5.
- K102670: Total Shoulder System, Shoulder Innovations, LLC (2011) Summary page 5.
- K091196: GRS Glenoid Resurfacing System, Arthrosurface, Inc. (2009) Summary page 5.
- K202289: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA), Stryker GmbH (2020) Summary page 5.

## Indications for use
Prosthetic replacement with the Tornier Perform Advanced Glenoid implants may be indicated to relieve severe pain or significant disability caused by: • Degenerative pathologies: osteoarthritis and post-traumatic arthritis • Revision surgery when other treatments or devices have failed if sufficient bone stock remains Refer to the Indications for the compatible humeral systems. Tornier Perform Advanced Glenoid is compatible with the following humeral systems: • Tornier Perform Humeral System - Stem • Tornier Perform Humeral System - Stemless • Tornier Perform Humeral System - Fracture • Tornier HRS • Tornier HRS Max • Tornier Flex Shoulder System • Tornier Simpliciti Shoulder System • ReUnion Shoulder System Tornier Perform Advanced Glenoid is intended for cemented use only. Tornier Perform humeral components are intended for cemented and un-cemented use, except for stemless systems (Tornier Perform Humeral System - Stemless and the Tornier Simpliciti Shoulder System) which are intended for press-fit (un-cemented) use only.

Source page: https://510kreport.com/device/K260721
Methodology: https://510kreport.com/methodology