Sculptor Robotic Guidance Arm (Rga)
FDA 510(k) K121765 · Stanmore Implants Worldwide , Ltd.
510(k) numberK121765
Submission
- Device name
- Sculptor Robotic Guidance Arm (Rga)
- Applicant
- Stanmore Implants Worldwide , Ltd.
Washington, DC, US - Received
- June 15, 2012
- Decision date
- January 11, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLO – Orthopedic Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Other 510(k)s with product code OLO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262506 | Remex Spine Surgery Navigation - Universal InstrumentsOLO · Special | Remex Medical Corp. | 08/20/2026SE |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…OLO · Traditional | Suite 201, National Innovation Centre | 07/30/2026SE |
| K261205 | SPINEART Navigation Instrument SystemOLO · Traditional | Spineart SA | 07/29/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | SurGenTec, LLC | 07/24/2026SE |
| K261024 | TMINI Miniature Robotic SystemOLO · Traditional | THINK Surgical, Inc. | 07/24/2026SE |
| K261113 | Op.n Spine Navigation and Robotic GuidanceOLO · Traditional | Ecential Robotics | 07/22/2026SE |
| K261852 | OTS HipOLO · Special | Ortoma AB | 07/01/2026SE |
| K253921 | VERTICALE® Navigation InstrumentsOLO · Traditional | Silony Medical GmbH | 06/26/2026SE |
| K260480 | VELYS Robotic-Assisted SolutionOLO · Traditional | Depuy Ireland UC | 06/25/2026SE |
| K260369 | Dynamis Robotic Surgical SystemOLO · Traditional | LEM Surgical AG | 06/20/2026SE |
More from LEM Surgical AG
| 510(k) | Device | Decision |
|---|---|---|
| K140898 | Patient Specific Distal FemoralKRO · Special | 01/20/2015SE |
| K133152 | JTS Extendible Distal Femoral ImplantKRO · Special | 01/22/2014SE |
| K121056 | Mets Modular Proximal FemurJDI · Traditional | 09/20/2012SE |
| K121055 | Mets Modular Total FemurJDI · Traditional | 09/19/2012SE |
| K121029 | Mets Modular Distal FemurKRO · Traditional | 09/19/2012SE |
| K120992 | Mets Smiles Total Knee ReplacementKRO · Traditional | 09/05/2012SE |
| K092138 | JTS Extendeable ImplantKRO · Traditional | 03/22/2011SE |
Questions and answers
When was Sculptor Robotic Guidance Arm (Rga) cleared by the FDA?
Sculptor Robotic Guidance Arm (Rga) (K121765) received a 510(k) decision of Substantially Equivalent on January 11, 2013, 210 days after the submission was received.
What is the product code of K121765?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.