Tsolution One Surgical System
TSolution One is an image-based planning and robotic preparation system for primary cementless total hip replacement through a posterior approach. It uses patient CT data to plan…
TSolution One is an image-based planning and robotic preparation system for primary cementless total hip replacement through a posterior approach. It uses patient CT data to plan preparation of the femoral canal and acetabulum.
TPLAN provides the preoperative workstation, while TCAT combines an electromechanical arm, control electronics, computer and display. Under the surgeon’s direction, the robotic tool implements the approved preparation plan.
Listed Item
SURGERY SUPPOR KIT, THA Cup US, 10 PACKS / CARTON
Registration and Accessories
Point-to-surface registration relates the plan to the patient. The system also establishes reference alignment axes for implant positioning. Supporting accessories include cutters, drapes, irrigation sets, probes and markers, forming the procedural side of the wider surgical-system family.
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) | K153647 |
| Record published | 2016-09-24 |
| Record revised | 2026-03-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 5 |
| Sizes | Length 11 to 125 mm; length 30 to 42 in; width 2.5 to 8 mm; outer diameter 6 to 8.25 mm; width 1.125 in |
| Distribution end date | 2025-10-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 107649 | In distribution | |
| 102794 | Length 11 mm | In distribution |
| 107645 | In distribution | |
| 103306 | Length 125 mm | In distribution |
| 102613 | Length 11 mm | In distribution |
| 107719 | Length 70 mm | In distribution |
| 103305 | Length 125 mm | In distribution |
| 107644 | Withdrawn | |
| 107665 | Withdrawn | |
| 105717 | Withdrawn | |
| 107667 | Withdrawn | |
| 106382 | Withdrawn | |
| 102709 | Withdrawn | |
| 103636 | Withdrawn | |
| 103426 | Withdrawn | |
| 102940 | Withdrawn | |
| 103593 | Withdrawn | |
| 108200 | Withdrawn | |
| 107650 | Withdrawn | |
| 100573 | Length 30 in | Withdrawn |
| 103279 | Width 8 mm | Withdrawn |
| 107666 | Withdrawn | |
| 103205 | Withdrawn | |
| 105715 | Withdrawn | |
| 100086 | Width 1.125 in | Withdrawn |
| 105734 | Outer Diameter 6 mm | Withdrawn |
| 103725 | Length 42 in | Withdrawn |
| 105934 | Withdrawn | |
| 106298-04 | Withdrawn | |
| 103414 | Withdrawn | |
| 101884 | Withdrawn | |
| 105716 | Width 2.5 mm | Withdrawn |
| 106298-03 | Withdrawn | |
| 105653 | Withdrawn | |
| 107642 | Withdrawn | |
| 106219 | Withdrawn | |
| 104948 | Withdrawn | |
| 103384 | Withdrawn | |
| 102862-NS | Outer Diameter 8.25 mm | Withdrawn |
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
3 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 | |
| 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 | |
| 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.