# K211359: Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Nov 12, 2021 after 193 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K905070 (1991). 108 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161742: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, Tornier, Inc. (2016) Summary page 5.
- K203315: BLUEPRINT™ Patient Specific Instrumentation, Tornier S.A.S. (2021) Summary page 5.

## Most influential descendants
- K232265: BLUEPRINT™ Patient Specific Instrumentation (2024), 3 descendants of its own
- K232425: Signature™ ONE System (2023), 2 descendants of its own
- K260104: Signature™ ONE System (2026), 1 descendant of its own
- K241491: Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid (2024), 1 descendant of its own
- K261510: Signature™ ONE System (2026), 0 descendants of its own

## Recalls of this device
- Apr 10, 2025 · Class II · Z-1738-2025: A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
- Apr 16, 2024 · Class II · Z-1883-2024: The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regu

## Indications for use
Tornier Perform™ Patient-Matched Primary Reversed Glenoid The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: * Rheumatoid arthritis * Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) * Correction of functional deformity * Fractures of the humeral head * Traumatic arthritis * Revision of glenohumeral joint if sufficient native glenoid bone remains All components are single use. The Patient-Matched Glenoid implant is anchored to the bone with screws and is for non-cemented fixation. Note: A CT Scan is used to create the Tornier Perform Patient-Matched Primary Reversed Glenoid implant. BLUEPRINT™ Patient Specific Instrumentation BLUEPRINT™ Glenoid Guides The BLUEPRINT™ Glenoid Guides are intended to be used as surgical instruments to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. BLUEPRINT™ 3D Planning Software BLUEPRINT™ 3D Planning Software is a medical device for surgeons. BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder replacement surgery. BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format. BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific components (Patient-Specific instruments and Tornier Perform™ Patient-Matched Primary Reversed Glenoid*) based on the pre-surgical plan. BLUEPRINT™ 3D Planning Software leads to the generation of a planning report. BLUEPRINT™ 3D Planning Software is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose. Note: Measures and patient specific guide design are provided depending on the case profiles. *Only if Patient-Specific instruments or Tornier Perform™ Patient-Matched Primary Reversed Glenoid are available in your geography.

Source page: https://510kreport.com/device/K211359
Methodology: https://510kreport.com/methodology