KneeAlign 2
Resection Stylus, Adjustable, Captured, Low Clearance
5manufacturers in China registered for this device type
76catalogue numbers in this listing
12510(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 | OrthAlign, 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) | K130387 |
| Record published | 2017-01-12 |
| Record revised | 2024-11-20 (version 7) |
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 |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 10 to 70 % RH; Handling environment temperature 15 to 25 °C; Special storage condition: Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.; Storage environment temperature -30 to 60 °C; Storage environment humidity 10 to 95 % RH |
| Packaging | 2-pack (p/n 402394) of 2, 2-pack (pn 402395) of 2, box of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 401644 | In distribution | |
| 402064-04 | In distribution | |
| 401572 | In distribution | |
| 402042 | In distribution | |
| 402100-01 | In distribution | |
| 133631-01 | In distribution | |
| 401318 | In distribution | |
| 402064-09 | In distribution | |
| 401650 | In distribution | |
| 402049 | In distribution | |
| 402046-08 | In distribution | |
| 401332 | In distribution | |
| 133632-06 | In distribution | |
| 401587 | In distribution | |
| 402096 | In distribution | |
| 402064-10 | In distribution | |
| 401592 | In distribution | |
| 402104 | In distribution | |
| 402103 | In distribution | |
| 402067 | In distribution | |
| 401744 | In distribution | |
| 402069 | In distribution | |
| 401290 | In distribution | |
| 401640 | In distribution | |
| 401645 | In distribution | |
| 402064-06 | In distribution | |
| 133632 | In distribution | |
| 402073-1 | In distribution | |
| 401578 | In distribution | |
| 402098 | In distribution | |
| 402066-4 | In distribution | |
| 401641 | In distribution | |
| 402066-5 | In distribution | |
| 402073 | In distribution | |
| 402064-07 | In distribution | |
| 402066-1 | In distribution | |
| 401639 | In distribution | |
| 402438 | In distribution | |
| 401285 | In distribution | |
| 401500 | In distribution | |
| 403189 | In distribution | |
| 401591 | In distribution | |
| 402047-03 | In distribution | |
| 401590 | In distribution | |
| 401610 | In distribution | |
| 401609 | In distribution | |
| 401483 | In distribution | |
| 401648 | In distribution | |
| 402043 | In distribution | |
| 401579 | In distribution | |
| 401576 | In distribution | |
| 402441 | In distribution | |
| 401770 | In distribution | |
| 401594 | In distribution | |
| 402048 | In distribution | |
| 402418 | In distribution | |
| 402046 | In distribution | |
| 401313 | In distribution | |
| 401612 | In distribution | |
| 401575 | In distribution | |
| 401571 | In distribution | |
| 402066-2 | In distribution | |
| 402064-05 | In distribution | |
| 401616 | In distribution | |
| 401548 | In distribution | |
| 401573 | In distribution | |
| 402066-3 | In distribution | |
| 401294 | In distribution | |
| 401651 | In distribution | |
| 402097 | In distribution | |
| 402066-6 | In distribution | |
| 402068 | In distribution | |
| 401582 | In distribution | |
| 401298 | In distribution | |
| 401743 | In distribution | |
| 133631 | 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 |
|---|---|
| K200892 | 2020-06-18 |
| K200642 | 2020-04-10 |
| K172462 | 2017-11-22 |
| K171780 | 2017-07-11 |
| K163379 | 2017-03-02 |
| K162962 | 2017-01-23 |
| K153237 | 2016-03-01 |
| K140331 | 2014-06-10 |
| K130387 | 2013-11-08 |
| K103829 | 2011-04-04 |
| K093998 | 2010-03-22 |
| K091411 | 2009-09-25 |
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 |
|---|---|---|---|---|
| 2026-02-10 | Class II | Nonconforming Material/Component | Drill plates manufactured out of specification can result in a bone cut in excess 00800″(2.8448mm) | 7 units |
| 2026-02-10 | Class II | Nonconforming Material/Component | Drill plates manufactured out of specification can result in a bone cut in excess 00800″(2.8448mm) | 7 units |
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.