Mako Total Knee Application
FDA 510(k) K241011 · Mako Surgical Corp.
510(k) numberK241011
Submission
- Device name
- Mako Total Knee Application
- Applicant
- Mako Surgical Corp.
Weston, FL, US - Received
- April 12, 2024
- Decision date
- June 11, 2024
- 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 |
|---|---|---|
| K260222 | Mako Total Knee ApplicationOLO · Special | 02/25/2026SE |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip PointerOLO · Traditional | 04/25/2025SE |
| K243751 | Mako Total Hip Application 5.0OLO · Traditional | 03/05/2025SE |
| K242373 | Mako Shoulder Application (1.0)OLO · Traditional | 11/07/2024SE |
| K220930 | Restoris Multi-Compartmental Knee SystemHSX · Traditional | 06/02/2022SE |
| K220459 | Mako Total Knee ApplicationOLO · Traditional | 04/15/2022SE |
| K193515 | Mako Total Knee ApplicationOLO · Traditional | 07/14/2020SE |
| K193128 | Mako Total Hip ApplicationOLO · Traditional | 02/02/2020SE |
| K191998 | Mako Total Hip Application, Mako Total Knee ApplicationOLO · Traditional | 09/24/2019SE |
| K172301 | Mako Partial Knee ApplicationOLO · Special | 11/02/2017SE |
Questions and answers
When was Mako Total Knee Application cleared by the FDA?
Mako Total Knee Application (K241011) received a 510(k) decision of Substantially Equivalent on June 11, 2024, 60 days after the submission was received.
What is the product code of K241011?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.