510(k) submissions
Filtered by Knee Surgery · showing 1–44 of 44
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K260601 | REAL INTELLIGENCE™ CORI™Knee Surgery | Blue Belt Technologies, Inc.United States | Stereotactic Surgery | Class 2 | 2026-03-26 |
| K252037 | CUVIS-joint (CJ150)Knee Surgery | Curexo, Inc.Korea, Republic of | Robotic Navigation | Class 2 | 2026-03-25 |
| K260010 | TMINI® Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2026-03-03 |
| K260222 | Mako Total Knee ApplicationKnee Surgery | Mako Surgical Corp.United States | Stereotactic Surgery | Class 2 | 2026-02-25 |
| K252058 | ROSA Knee System with UltraSound Imaging Platform (USIP)Knee Surgery | Balmoral Medical, LLCUnited States | Stereotactic Surgery | Class 2 | 2026-02-06 |
| K253661 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2025-12-22 |
| K252841 | REAL INTELLIGENCE™ CORI™ XT (CORI XT)Knee Surgery | Blue Belt Technologies, Inc.United States | Stereotactic Surgery | Class 2 | 2025-12-05 |
| K251314 | Rosa® Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2025-11-13 |
| K252544 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2025-10-10 |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip PointerKnee Surgery | Stryker InstrumentsUnited States | Software Navigation | Class 2 | 2025-09-25 |
| K250877 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2025-06-20 |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip PointerKnee Surgery | Mako Surgical Corp.United States | Stereotactic Surgery | Class 2 | 2025-04-25 |
| K243481 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2025-01-06 |
| K243285 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2024-11-15 |
| K242264 | TMINI Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2024-08-23 |
| K242009 | 360CAS KneeKnee Surgery | Kico Knee Innovation Company Pty, Ltd.Australia | Image Guided Surgery | Class 2 | 2024-08-08 |
| K241031 | TMINI Miniature Robotic System (TMINI 1.1)Knee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2024-07-12 |
| K240721 | ExcelsiusFlex™Knee Surgery | Globus Medical, Inc.United States | Software Navigation | Class 2 | 2024-06-14 |
| K241011 | Mako Total Knee ApplicationKnee Surgery | Mako Surgical Corp.United States | Stereotactic Surgery | Class 2 | 2024-06-11 |
| K240211 | VELYS Robotic-Assisted SolutionKnee Surgery | Depuy Ireland UCIreland | Stereotactic Surgery | Class 2 | 2024-06-05 |
| K240139 | Real Intelligence™ CORI™Knee Surgery | Blue Belt Technologies, Inc.United States | Software Navigation | Class 2 | 2024-03-18 |
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance SystemKnee Surgery | Stryker Leibinger GmbH & Co KGGermany | Software Navigation | Class 2 | 2024-03-14 |
| K233299 | ExactechGPS® SystemKnee Surgery | Blue OrthoFrance | Stereotactic Surgery | Class 2 | 2024-01-26 |
| K233227 | VELYS™ Robotic-Assisted SolutionKnee Surgery | Depuy Ireland UCIreland | Stereotactic Surgery | Class 2 | 2023-12-14 |
| K232533 | ROSA Partial Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2023-11-16 |
| K232802 | TMINI™ Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2023-10-12 |
| K231963 | REAL INTELLIGENCE™ CORI™Knee Surgery | Blue Belt Technologies, Inc.United States | Software Navigation | Class 2 | 2023-08-01 |
| K231172 | ApolloKneeKnee Surgery | Corin U.S.A. LimitedUnited States | Stereotactic Surgery | Class 2 | 2023-07-26 |
| K230876 | RI.KNEE Adjustable Tibia Cut GuideKnee Surgery | Enztec LimitedNew Zealand | Robotic Navigation | Class 2 | 2023-06-27 |
| K230202 | TMINI™ Miniature Robotic SystemKnee Surgery | THINK Surgical, Inc.United States | Stereotactic Surgery | Class 2 | 2023-04-25 |
| K230243 | ROSA® Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2023-03-29 |
| K230180 | Rosa Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2023-02-22 |
| K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance SystemKnee Surgery | Stryker Leibinger GmbH & Co KGGermany | Software Navigation | Class 2 | 2023-02-13 |
| K223351 | Naviswiss KneeKnee Surgery | Naviswiss AGSwitzerland | Software Navigation | Class 2 | 2023-01-31 |
| K223927 | 360CASKnee Surgery | Kico Knee Innovation Company Pty, Ltd.Australia | Software Navigation | Class 2 | 2023-01-27 |
| K221928 | ROSA® Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2022-10-04 |
| K221224 | REAL INTELLIGENCE CORIKnee Surgery | Blue Belt Technologies, Inc.United States | Software Navigation | Class 2 | 2022-08-19 |
| K220958 | Real Intelligence CoriKnee Surgery | Blue Belt Technologies, Inc.United States | Software Navigation | Class 2 | 2022-07-27 |
| K213873 | SkyWalker Total Knee SystemKnee Surgery | Microport Navibot International, LLCUnited States | Stereotactic Surgery | Class 2 | 2022-07-07 |
| K220652 | Knee 3Knee Surgery | Brainlab AGGermany | Stereotactic Surgery | Class 2 | 2022-06-03 |
| K213877 | ExactechGPS® SystemKnee Surgery | Blue OrthoFrance | Stereotactic Surgery | Class 2 | 2022-05-02 |
| K213708 | ROSA® Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2022-04-22 |
| K213033 | iASSIST Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2022-01-14 |
| K213380 | 360CASKnee Surgery | Kico Knee Innovation Company Pty, Ltd.Australia | Image Guided Surgery | Class 2 | 2022-01-11 |
