# K202151: Smart SPACE Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Techmah Medical, LLC
- Decided: Feb 3, 2021 after 184 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: 13 generations back to K905070 (1991). 101 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191247: SmartSPACE Shoulder System, Techmah Medical, LLC (2019) Summary page 5.

## Most influential descendants
- K222405: Smart SPACE Shoulder Planner and 3D Positioners (2022), 0 descendants of its own

## Indications for use
Smart SPACE Shoulder 3D Positioner Smart SPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. Smart SPACE Shoulder Cubit Guidance Smart SPACE Shoulder Cubit Guidance consists of a patient-specific 3D mapper, single use instrumentation, and an intraoperative guidance software. They have been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. Smart SPACE Shoulder Planner software Smart SPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. Smart SPACE Shoulder Planner software runs on standard personal and business computers running Microsoft Windows operating system. The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with the Smart SPACE Shoulder Planner software. Smart SPACE Shoulder Planner software allows the surgeon to visualize, measure, reconstruct, annotate and edit anatomic data. It allows the surgeon to design shoulder patient-specific instrumentation based on the pre-surgical plan. The software leads to the generation of a surgical report along with a 3D file of the shoulder patient-specific instrumentation. Smart SPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation. Smart SPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.

Source page: https://510kreport.com/device/K202151
Methodology: https://510kreport.com/methodology