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NAVIO Total Knee Arthroplasty DRILL GUIDE GENESIS II - LEGION
5manufacturers in China registered for this device type
66catalogue numbers in this listing
9510(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 | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K160537 |
| Record published | 2016-01-22 |
| Record revised | 2026-03-19 (version 6) |
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 |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Bag of 6, box of 2, cas of 10, box of 3 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PFSR101092 | In distribution | ||
| ROB00005 | In distribution | ||
| PFSD01008 | In distribution | ||
| NPFS02000F | In distribution | ||
| ROB00025 | In distribution | ||
| ROB00033 | In distribution | ||
| PFSR110005 | In distribution | ||
| ROB00004 | In distribution | ||
| PFSR110017 | In distribution | ||
| PFSR02050 | In distribution | ||
| PFSR110001 | In distribution | ||
| ROB00022 | In distribution | ||
| ROB00003 | In distribution | ||
| ROB00016 | In distribution | ||
| ROB00001 | In distribution | ||
| PFSR101083 | In distribution | ||
| PFSDV0016 | 9 | In distribution | |
| PFSR110006 | In distribution | ||
| ROB00018 | In distribution | ||
| ROB00006 | In distribution | ||
| ROB00011 | In distribution | ||
| ROB00024 | In distribution | ||
| PFSR110018 | In distribution | ||
| PFSR101068 | In distribution | ||
| ROB00029 | In distribution | ||
| ROB00030 | In distribution | ||
| PFSR02050KT | In distribution | ||
| PFSR100026 | 2 | In distribution | |
| NPFS02000 | In distribution | ||
| PFSR110137F | In distribution | ||
| ROB00007 | In distribution | ||
| ROB00031 | In distribution | ||
| ROB00008 | In distribution | ||
| ROB00076 | In distribution | ||
| PFSR101063 | In distribution | ||
| PFSR101064 | In distribution | ||
| PFSR110120 | In distribution | ||
| PFSR110008 | In distribution | ||
| ROB00028 | In distribution | ||
| ROB00032 | 3 | In distribution | |
| ROB00009 | In distribution | ||
| ROB00015 | In distribution | ||
| PFSR120010 | In distribution | ||
| PFSR110006F | In distribution | ||
| ROB00061 | In distribution | ||
| PFSR015001 | In distribution | ||
| PFSR02050F | In distribution | ||
| PFSR101065 | In distribution | ||
| PFSR100810 | In distribution | ||
| ROB00014 | In distribution | ||
| ROB00026 | In distribution | ||
| ROB00023 | In distribution | ||
| ROB00060 | In distribution | ||
| PFSR101066 | In distribution | ||
| PFSR110119 | In distribution | ||
| PFSR110137 | In distribution | ||
| ROB00021 | In distribution | ||
| PFSR101098 | In distribution | ||
| PFSR120031 | In distribution | ||
| PFSR110164 | In distribution | ||
| ROB00035 | In distribution | ||
| PFSR101067 | In distribution | ||
| PFSD01009 | 4 | In distribution | |
| ROB00012 | In distribution | ||
| ROB00027 | In distribution | ||
| PFSR110002 | 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 |
|---|---|
| K180277 | 2018-04-24 |
| K170977 | 2017-05-03 |
| K170280 | 2017-04-28 |
| K130748 | 2013-08-04 |
| K110240 | 2011-04-14 |
| K100107 | 2010-02-23 |
| K092497 | 2009-09-11 |
| K090420 | 2009-05-27 |
| K090313 | 2009-03-11 |
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 |
|---|---|---|---|---|---|
| 2020-02-27 | Class II | Device Design | Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins. | 348 units | 2024-08-02 |
| 2010-10-15 | Not classified | Other | Targeting software has been found to provide erroneous targeting when used with the 13 mm TAN/FAN Left nails. | 445 units | 2011-02-17 |
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.