Tmini® Guide Block Kit for Medacta® Knee System
TMINI® Guide Block Kit for Medacta® GMK® Sphere / SpheriKA Knee Systems, Ultimate Knee Instruments Only
5manufacturers in China registered for this device type
1catalogue number
19510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Think Surgical Inc., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K230202 |
| Record published | 2025-04-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 109973 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Masada | Astura Medical | 335 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261024 | 2026-07-24 |
| K260010 | 2026-03-03 |
| K253661 | 2025-12-22 |
| K252544 | 2025-10-10 |
| K250877 | 2025-06-20 |
| K243481 | 2025-01-06 |
| K243285 | 2024-11-15 |
| K242264 | 2024-08-23 |
| K241031 | 2024-07-12 |
| K232802 | 2023-10-12 |
| K230202 | 2023-04-25 |
| K210668 | 2021-04-01 |
| K203040 | 2020-11-13 |
| K201255 | 2020-06-10 |
| K193135 | 2019-12-11 |
| K191369 | 2019-10-08 |
| K170430 | 2017-03-06 |
| K162195 | 2016-09-14 |
| K153647 | 2016-02-16 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Think Surgical Inc. | 510(k) number | 2024-02-12 | Class II | Device Design | There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array | 16 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-05-08 | Class II | Process control | Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. | 360 devices | |
| 2018-03-30 | Class II | Process control | There is a potential for the cutter head to detach from the cutter shaft. | 951 | 2020-01-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.