Intellijoint Knee®
Adjustable Cutting Guide Base
5manufacturers in China registered for this device type
19catalogue numbers in this listing
6510(k) clearances naming this product code
2recalls 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 | Intellijoint Surgical Inc., Canada |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K191507 |
| Record published | 2021-02-22 |
| Record revised | 2020-03-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 000-0559 | In distribution | ||
| 000-0561 | In distribution | ||
| 000-0508 | In distribution | ||
| 000-0550 | 4 | In distribution | |
| 000-0521 | In distribution | ||
| 000-0519 | In distribution | ||
| 000-0551 | In distribution | ||
| 000-0518 | 4 | In distribution | |
| 000-0536 | In distribution | ||
| 000-0513 | In distribution | ||
| 000-0570 | In distribution | ||
| 000-0502 | In distribution | ||
| 000-0560 | In distribution | ||
| 000-0501 | In distribution | ||
| 000-0530 | In distribution | ||
| 000-0541 | In distribution | ||
| 000-0566 | In distribution | ||
| 000-0501 | In distribution | ||
| 000-0526 | 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 |
|---|---|
| K191507 | 2019-10-01 |
| K172849 | 2017-11-16 |
| K171525 | 2017-10-30 |
| K162364 | 2017-03-02 |
| K151364 | 2015-12-28 |
| K133759 | 2014-07-23 |
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 | Closed |
|---|---|---|---|---|---|---|
| Intellijoint Surgical Inc. | 510(k) number | 2020-02-11 | Class II | Software design | During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth. | 2020-06-10 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2019-06-28 | Class II | Nonconforming Material/Component | Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the battery may overheat and pose a fire safety risk. To date, Intellijoint has distributed, 15-inch MacBook Pros which are the Workstation compo | 23 units | 2020-09-16 |
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.