Pillar SA
5.0mm x 30mm Semi-Constrained Bone Screw Implant Grade Titanium
3manufacturers in China registered for this device type
96catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 | Orthofix US LLC, United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-08-01 |
| Record revised | 2026-02-20 (version 4) |
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 |
| Sizes | Length 20 to 43 mm; height 12.5 to 20 mm; width 28 to 32 mm; outer diameter 5 to 5.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 49-4016 | Height 16 mm | In distribution |
| 49-8214 | Height 14 mm | In distribution |
| 49-9014 | Height 14 mm | In distribution |
| 49-3016 | Height 16 mm | In distribution |
| 49-6018 | Height 18 mm | In distribution |
| 49-6218 | Height 18 mm | In distribution |
| 49-2020 | Height 20 mm | In distribution |
| 49-8012 | Height 12.5 mm | In distribution |
| 49-9616 | Height 16 mm | In distribution |
| 49-8016 | Height 16 mm | In distribution |
| 49-8216 | Height 16 mm | In distribution |
| 49-9618 | Height 18 mm | In distribution |
| 49-6016 | Height 16 mm | In distribution |
| 49-8020 | Height 20 mm | In distribution |
| 49-5130 | Outer Diameter 5.0 mm | In distribution |
| 49-8018 | Height 18 mm | In distribution |
| 49-3018 | Height 18 mm | In distribution |
| 49-7220 | Height 20 mm | In distribution |
| 49-9020 | Height 20 mm | In distribution |
| 49-2016 | Height 16 mm | In distribution |
| 49-4216 | Height 16 mm | In distribution |
| 49-4218 | Height 18 mm | In distribution |
| 49-2212 | Height 12.5 mm | In distribution |
| 49-5030 | Outer Diameter 5.0 mm | In distribution |
| 49-3020 | Height 20 mm | In distribution |
| 49-4020 | Height 20 mm | In distribution |
| 49-5125 | Outer Diameter 5.0 mm | In distribution |
| 49-5120 | Outer Diameter 5.0 mm | In distribution |
| 49-8014 | Height 14 mm | In distribution |
| 49-4014 | Height 14 mm | In distribution |
| 49-5530 | Outer Diameter 5.5 mm | In distribution |
| 49-7020 | Height 20 mm | In distribution |
| 49-5535 | Outer Diameter 5.5 mm | In distribution |
| 49-6220 | Height 20 mm | In distribution |
| 49-4018 | Height 18 mm | In distribution |
| 49-5525 | Outer Diameter 5.5 mm | In distribution |
| 49-3212 | Height 12.5 mm | In distribution |
| 49-3214 | Height 14 mm | In distribution |
| 49-9212 | Height 12.5 mm | In distribution |
| 49-9614 | Height 14 mm | In distribution |
| 49-9220 | Height 20 mm | In distribution |
| 49-8220 | Height 20 mm | In distribution |
| 49-0033 | Length 33 mm | In distribution |
| 49-2218 | Height 18 mm | In distribution |
| 49-9214 | Height 14 mm | In distribution |
| 49-6214 | Height 14 mm | In distribution |
| 49-2018 | Height 18 mm | In distribution |
| 49-4220 | Height 20 mm | In distribution |
| 49-9612 | Height 12.5 mm | In distribution |
| 49-7018 | Height 18 mm | In distribution |
| 49-9218 | Height 18 mm | In distribution |
| 49-7016 | Height 16 mm | In distribution |
| 49-7214 | Height 14 mm | In distribution |
| 49-8212 | Height 12.5 mm | In distribution |
| 49-3014 | Height 14 mm | In distribution |
| 49-7014 | Height 14 mm | In distribution |
| 49-3012 | Height 12.5 mm | In distribution |
| 49-9414 | Height 14 mm | In distribution |
| 49-2012 | Height 12.5 mm | In distribution |
| 49-5035 | Outer Diameter 5.0 mm | In distribution |
| 49-5135 | Outer Diameter 5.0 mm | In distribution |
| 49-9420 | Height 20 mm | In distribution |
| 49-6020 | Height 20 mm | In distribution |
| 49-6212 | Height 12.5 mm | In distribution |
| 49-6012 | Height 12.5 mm | In distribution |
| 49-7212 | Height 12.5 mm | In distribution |
| 49-9018 | Height 18 mm | In distribution |
| 49-9418 | Height 18 mm | In distribution |
| 49-6216 | Height 16 mm | In distribution |
| 49-3216 | Height 16 mm | In distribution |
| 49-9620 | Height 20 mm | In distribution |
| 49-6014 | Height 14 mm | In distribution |
| 49-7012 | Height 12.5 mm | In distribution |
| 49-5025 | Outer Diameter 5.0 mm | In distribution |
| 49-9012 | Height 12.5 mm | In distribution |
| 49-8218 | Height 18 mm | In distribution |
| 49-2214 | Height 14 mm | In distribution |
| 49-0043 | Length 43 mm | In distribution |
| 49-0040 | Length 40 mm | In distribution |
| 49-4214 | Height 14 mm | In distribution |
| 49-4212 | Height 12.5 mm | In distribution |
| 49-9216 | Height 16 mm | In distribution |
| 49-9416 | Height 16 mm | In distribution |
| 49-4012 | Height 12.5 mm | In distribution |
| 49-2220 | Height 20 mm | In distribution |
| 49-5020 | Outer Diameter 5.0 mm | In distribution |
| 49-0037 | Length 37 mm | In distribution |
| 49-9016 | Height 16 mm | In distribution |
| 49-3220 | Height 20 mm | In distribution |
| 49-2014 | Height 14 mm | In distribution |
| 49-3218 | Height 18 mm | In distribution |
| 49-9412 | Height 12.5 mm | In distribution |
| 49-7218 | Height 18 mm | In distribution |
| 49-7216 | Height 16 mm | In distribution |
| 49-5520 | Outer Diameter 5.5 mm | In distribution |
| 49-2216 | Height 16 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-11-19 | Not classified | Nonconforming Material/Component | The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning. | 29 instruments | 2010-02-02 |
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.