# K222405: Smart SPACE Shoulder Planner and 3D Positioners

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Dec 20, 2022 after 133 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: 14 generations back to K905070 (1991). 103 ancestors in all.
No later device cites it as a predicate yet.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202151: Smart SPACE Shoulder System, Techmah Medical, LLC (2021) Summary page 5.
- K202454: Smart SPACE Shoulder System, Techmah Medical, LLC (2020) Summary page 5.
- K191247: SmartSPACE Shoulder System, Techmah Medical, LLC (2019) Summary page 5.

## Indications for use
The Smart SPACE Shoulder 3D Positioners and Smart SPACE Shoulder Anatomical Models are intended to be used as surgical instruments for adult patients that are candidates for primary elective shoulder replacement surgery and they are intended to be a surgical tool to transfer a pre-operative plan into surgery, designed on the basis of patient-specific pre-operative CT scans. The Smart SPACE Shoulder 3D Positioners are intended, by guiding the surgical instruments in some steps of the orthopedic surgical procedure, to prepare the bone to host the implantable components. The Smart SPACE Shoulder Anatomical Models are a 3D representation of the patient anatomical condition, as previously evaluated by the surgeon. The model is intended to be used to check that the 3D Positioners is properly placed on the anatomical compartment. These devices must be exclusively utilized by an orthopaedic surgeon who has a good knowledge of the specific operative technique. Smart SPACE Shoulder 3D Positioners and Anatomical Models are indicated for use on adult patients that are candidates for primary elective reverse and anatomic total shoulder arthroplasty. Smart SPACE Shoulder Planner Smart SPACE Shoulder Planner 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 does not include any system to manufacture the shoulder patient-specific instrumentation. Smart SPACE Shoulder Planner is to be used for adult patients only and should not be used for diagnostic purposes. Smart SPACE Shoulder Planner is intended to be used for adult patients planning only. The Smart SPACE Shoulder Planner is intended for use with patients that are candidates for primary reverse and anatomic total shoulder arthroplasty. The specific functionalities of the Smart SPACE Shoulder Planner version are described in the User Manual and Quick Start Guide provided by LimaCorporate.

Source page: https://510kreport.com/device/K222405
Methodology: https://510kreport.com/methodology