# K241491: Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation (Tornier, S.A.S.)
- Decided: Oct 10, 2024 after 139 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- 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: 15 generations back to K905070 (1991). 110 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232265: BLUEPRINT™ Patient Specific Instrumentation, Tornier S.A.S. (2024)
- K211359: Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation, Tornier, Inc. (2021) Summary page 6.

## Most influential descendants
- K253674: Blueprint Patient-Specific Instrumentation (2026), 0 descendants of its own

## Indications for use
BLUEPRINT Patient Specific Instrumentation IFU: Hardware The BLUEPRINT Glenoid Guides are patient-specific drill guides. They have been specially designed 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. Software Blueprint is a medical device for surgeons. Blueprint is intended to be used as a pre-surgical planner for shoulder replacement surgery. Blueprint requires CT scan images showing the anatomical shoulder structure in a DICOM format. Blueprint allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. Blueprint allows surgeons to design patient specific components (patient-specific instruments and Shoulder iD Primary Reversed Glenoid*) based on the pre-surgical plan. Blueprint leads to the generation of a planning report. Blueprint 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 Shoulder iD Primary Reversed Glenoid are available in your geography. Shoulder iD Primary Reversed Glenoid IFU: The Shoulder iD 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 Shoulder iD Primary Reversed Glenoid implant is anchored to the bone with screws and is for non-cemented fixation. Note: A CT Scan is used to create the Shoulder iD Primary Reversed Glenoid implant

Source page: https://510kreport.com/device/K241491
Methodology: https://510kreport.com/methodology