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Sculptor Robotic Guidance Arm (RGA)

by Stanmore Implants Worldwide Ltd

510(k) K121765

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121765 Date11 Jan 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OLO
FDA applicant
Stanmore Implants Worldwide , Ltd.
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sculptor Robotic Guidance Arm (RGA) is a robotic system designed to assist surgeons by providing software-defined spatial boundaries for orientation and reference information relative to anatomical structures. It utilizes a robotic arm to limit the operation of a milling tool to a safe area and incorporates a tracking arm for precision during orthopedic procedures.

This device is indicated for use in unicompartmental knee replacement procedures where stereotactic surgery is appropriate. It has received FDA 510(k) clearance as a Class 2 orthopedic device under product code OLO.

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