NavitrackER®
3 catalogue numbers from 20-8087-000-00, listed by Orthosoft, Inc., Canada, under Orthopedic Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
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 | Orthosoft, Inc., Canada |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| 510(k) | K260582 |
| Record published | 2026-06-26 |
| Record revised | 2023-05-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 20-8087-000-00 | In distribution | ||
| 20-8000-070-05 | In distribution | ||
| 20-8000-000-07 | 6 | 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 |
|---|---|
| K100599 | 2010-04-05 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer CAS | UDI-DI | 2022-01-07 | Class II | Under Investigation by firm | The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention. | 14 units US; 132 units OUS | |
| Zimmer, Inc. | 510(k) number | 2009-11-02 | Not classified | Device Design | The power cord female receptacle is not recessed sufficiently and may present a shock hazard. | 71 | 2010-10-15 |
| Zimmer CAS | 510(k) number | 2008-10-28 | Class II | Software design | Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies. | 153 | 2017-05-15 |
| Zimmer CAS | 510(k) number | 2008-06-20 | Class III | Software design | ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System – OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3. | 152 | 2017-05-15 |
| Zimmer, Inc. | 510(k) number | 2007-08-06 | Not classified | Device Design | Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. The instrument may break during use, resulting in surgical delay and an increased risk of infection. | 39 | 2009-03-11 |
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.