# K121765: Sculptor Robotic Guidance Arm (Rga)

- Pathway: 510(k) (Traditional)
- Applicant: Stanmore Implants Worldwide, Ltd.
- Decided: Jan 11, 2013 after 210 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093425: Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha, Mako Surgical Corp. (2010) Summary page 2.

## Indications for use
The Sculptor Robotic Guidance Arm (RGA) is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Sculptor RGA is indicated for use in unicompartmental knee replacement, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT-based model of the anatomy.

Source page: https://510kreport.com/device/K121765
Methodology: https://510kreport.com/methodology