ApolloKnee
FDA 510(k) K231172 · Corin U.S.A. Limited
510(k) numberK231172
Submission
- Device name
- ApolloKnee
- Applicant
- Corin U.S.A. Limited
Tampa, FL, US - Received
- April 25, 2023
- Decision date
- July 26, 2023
- 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 |
|---|---|---|
| K242744 | Trinity EVO Acetabular ShellLPH · Traditional | 06/05/2025SE |
| K241808 | ApolloHipX (THR.SS.0001)LLZ · Traditional | 01/07/2025SE |
| K241472 | Icona Hip StemMEH · Traditional | 10/03/2024SE |
| K241570 | Unity Total Knee SystemJWH · Traditional | 09/23/2024SE |
| K240875 | Unity Knee PS-C Tibial InsertJWH · Traditional | 06/26/2024SE |
| K212069 | Corin MetaFix Hip StemLZO · Traditional | 04/07/2022SE |
| K191831 | MobiliT CupLZO · Traditional | 01/16/2020SE |
| K191374 | Revival Modular Hip StemLZO · Traditional | 07/22/2019SE |
| K183114 | Corin BiPolar-iKWY · Traditional | 06/05/2019SE |
| K183533 | Unity Total Knee SystemJWH · Traditional | 06/04/2019SE |
Questions and answers
When was ApolloKnee cleared by the FDA?
ApolloKnee (K231172) received a 510(k) decision of Substantially Equivalent on July 26, 2023, 92 days after the submission was received.
What is the product code of K231172?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.