Navbit Sprint_Lateral
Navbit Sprint Lateral guides acetabular cup alignment during hip arthroplasty with the patient in a lateral decubitus position. A palm-sized computer uses gyroscopes and accelerometers to…
Navbit Sprint Lateral guides acetabular cup alignment during hip arthroplasty with the patient in a lateral decubitus position. A palm-sized computer uses gyroscopes and accelerometers to measure inclination and anteversion in real time.
The system registers a pelvic coordinate frame and reports the introducer or impactor angle relative to that frame. It is intended for uncemented cups that permit correction after impaction.
Listed Item
Cup Alignment Technology for Hip Replacement
Placement Conditions
Confirmatory measurements must be possible after cup impaction. Any surgical approach allowing the required patient registration is appropriate. The system is supplied terminally sterilized as a single-use disposable device.
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 | Navbit PTY Ltd, Australia |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| 510(k) | K200376 |
| Record published | 2021-04-27 |
| Record revised | 2026-03-13 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature 10 to 25 °C; Special storage condition: Transport Temp. -29-60 Deg. Celsius and 15-90% RH |
| Sizes | Length 3 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HBS-00-002 | Length 3 in | 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 |
|---|---|
| K200376 | 2020-12-10 |
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.