# K243509: Archer PSI System

- Pathway: 510(k) (Traditional)
- Applicant: 3D-Side
- Decided: May 12, 2025 after 181 days
- Product code: QHE (Shoulder Arthroplasty Implantation System)
- 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: 11 generations back to K905070 (1991). 99 ancestors in all.
No later device cites it as a predicate yet.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190738: MyShoulder Placement Guides, Medacta International S.A. (2019) Summary page 5.

## Indications for use
ArcherR PSI System is indicated as an orthopedic instrument to assist the physician in the intra-operative positioning of total shoulder replacement components and in guiding the drill and the cut of the bone. ArcherR PSI System must only be used conjointly with Archer ™ CSR Total Shoulder (K152825, K173812, K181287, K182500, K191811), Catalyst EA Convertible Stemmed Shoulder (K222317) and Archer ™ R1 Reverse (K202611, K211991, K213349, K223655, K232583) components in the context of primary total shoulder replacement and following a delto-pectoral approach only. ArcherR PSI System is manufactured from a pre-operative planning validated by the surgeon in the 'Archer ™ 3D Targeting' platform (K213779). ArcherR PS I System is indicated for patient population fulfilling the Archer ™ CSR Total Shoulder, Catalyst EA Convertible Stemmed Shoulder and Archer ™ R1 Reverse indications and for which CT images are available with identifiable placement anatomical landmarks and compliant with imaging protocol provided by Archer 3D Targeting. The device is intended for single use only. The device is intended for adult patients. The device has to be used by a physician trained in the performance of surgery.

Source page: https://510kreport.com/device/K243509
Methodology: https://510kreport.com/methodology