Align
ALIGN Radial Stem, Long Trial 10.0mm
3manufacturers in China registered for this device type
97catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Skeletal Dynamics L.L.C. |
|---|---|
| FDA product code | KWI |
| Device type | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3170 |
| 510(k) | K092721 |
| Record published | 2015-10-30 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 7 to 26 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ALIGN, Trial, Radial Stem, 10.0mm | Outer Diameter 10 mm | In distribution |
| ALIGN Radial Stem, 9mm x 4mm | Outer Diameter 9 mm | In distribution |
| ALIGN, Radial Planer, Stem 7.0mm | Outer Diameter 7 mm | In distribution |
| Driver Extraction Tool | In distribution | |
| ALIGN, Radial Planer, Stem 11.0mm | Outer Diameter 11 mm | In distribution |
| ALIGN, Trial, Radial Neck, 0.0mm | In distribution | |
| ALIGN Radial Stem, 6mm x 4mm | In distribution | |
| ALIGN, Sizer, Radial Head Implant | In distribution | |
| ALIGN Radial Head System | In distribution | |
| ALIGN Radial Stem, 12mm x 6mm | Outer Diameter 10 mm | In distribution |
| ALIGN, Stem Impactor | In distribution | |
| ALIGN Radial Stem, 8mm x 6mm | Outer Diameter 8 mm | In distribution |
| ALIGN, Radial Rasp, Stem 9.0mm | Outer Diameter 9 mm | In distribution |
| ALIGN Radial Stem, 8mm x 4mm | Outer Diameter 8 mm | In distribution |
| ALIGN, Neck Gauge & Head Inserter, 6mm | In distribution | |
| ALIGN Radial Head & Lock Screw, 26mm | Outer Diameter 26 mm | In distribution |
| ALIGN Radial Stem, Long Trial 10.0mm | In distribution | |
| ALIGN, Trial, Radial Head, 18mm | Outer Diameter 18 mm | In distribution |
| ALIGN, Torque Handle, Radial Head | In distribution | |
| ALIGN, Trial, Radial Neck, 2.0mm | In distribution | |
| ALIGN, Radial Planer, Stem 10.0mm | Outer Diameter 10 mm | In distribution |
| ALIGN, Trial, Radial Neck, 6.0mm | In distribution | |
| ALIGN Radial Stem, 8mm x 2mm | Outer Diameter 8 mm | In distribution |
| ALIGN Radial Stem, 7mm x 0mm | Outer Diameter 7 mm | In distribution |
| ALIGN Radial Stem, Long Trial 6.0mm | In distribution | |
| ALIGN Radial Stem, 9mm x 2mm | Outer Diameter 9 mm | In distribution |
| ALIGN, Trial, Radial Neck, 8.0mm | In distribution | |
| ALIGN Radial Stem, Long Trial 11.0mm | In distribution | |
| ALIGN Radial Stem, Long Trial 9.0mm | In distribution | |
| ALIGN, Neck Gauge & Head Inserter, 2mm | In distribution | |
| ALIGN, Trial, Radial Head, 24mm | Outer Diameter 24 mm | In distribution |
| Head Alignment Tool, Side Load | In distribution | |
| Radial Rasp, Stem 6.0mm | In distribution | |
| Radial Rasp, Stem 12.0mm | In distribution | |
| Captive Rail & Axis Jig, Radial Head Guide | In distribution | |
| ALIGN, Trial, Radial Head, 26mm | Outer Diameter 26 mm | In distribution |
| ALIGN Radial Stem, 12mm x 2mm | In distribution | |
| ALIGN, Radial Rasp, Stem 7.0mm | Outer Diameter 7 mm | In distribution |
| ALIGN Radial Stem, 12mm x 0mm | In distribution | |
| ALIGN Radial Stem, Long Trial 7.0mm | In distribution | |
| ALIGN Radial Stem, 12mm x 8mm | Outer Diameter 10 mm | In distribution |
| ALIGN Radial Stem, 7mm x 6mm | Outer Diameter 7 mm | In distribution |
| ALIGN, Head Alignment Tool, Radial Head Guide | In distribution | |
| Driver, Universal QC, T-20 | In distribution | |
| ALIGN Radial Head Large Sizer Tray | In distribution | |
| ALIGN, Neck Gauge & Head Inserter, 8mm | In distribution | |
| ALIGN Radial Head & Lock Screw, 24mm | Outer Diameter 24 mm | In distribution |
| ALIGN, Trial, Radial Stem, 8.0mm | Outer Diameter 8 mm | In distribution |
| ALIGN, Bone Holding Forceps | In distribution | |
| ALIGN, Radial Planer, Stem 9.0mm | Outer Diameter 9 mm | In distribution |
| ALN-RHI-180 | Outer Diameter 18 mm | In distribution |
| ALIGN Radial Stem, 8mm x 0mm | Outer Diameter 8 mm | In distribution |
| ALIGN, Radial Rasp, Stem 11.0mm | Outer Diameter 11 mm | In distribution |
| ALIGN Radial Stem, 9mm x 0mm | Outer Diameter 9 mm | In distribution |
| ALIGN, Radial Planer, Stem 8.0mm | Outer Diameter 8 mm | In distribution |
| ALIGN Radial Stem, 11mm x 8mm | Outer Diameter 11 mm | In distribution |
| ALIGN Radial Stem, 9mm x 8mm | Outer Diameter 9 mm | In distribution |
| ALIGN, Trial, Radial Stem, 9.0mm | Outer Diameter 9 mm | In distribution |
| Trial, Radial Stem, 12.0mm | In distribution | |
| ALIGN Radial Stem, Long Trial 8.0mm | In distribution | |
| ALIGN, Radial Universal Planar | In distribution | |
| ALIGN, Neck Gauge & Head Inserter, 4mm | In distribution | |
| ALIGN Radial Stem, 7mm x 2mm | Outer Diameter 7 mm | In distribution |
| ALIGN, Radial Rasp, Stem 8.0mm | Outer Diameter 8 mm | In distribution |
| ALIGN Radial Stem, 8mm x 8mm | Outer Diameter 8 mm | In distribution |
| Head Alignment Tool | In distribution | |
| ALIGN Radial Stem, Long Trial 12.0mm | In distribution | |
| ALIGN Radial Stem, 10mm x 0mm | Outer Diameter 10 mm | In distribution |
| ALIGN Radial Stem, 7mm x 8mm | Outer Diameter 7 mm | In distribution |
| ALIGN Radial Stem, 12mm x 4mm | Outer Diameter 10 mm | In distribution |
| Trial, Radial Head, 28mm | In distribution | |
| ALIGN Radial Stem, 7mm x 4mm | Outer Diameter 7 mm | In distribution |
| ALIGN Radial Stem, 6mm x 0mm | In distribution | |
| ALIGN, Trial, Radial Head, 22mm | Outer Diameter 22 mm | In distribution |
| ALIGN, Neck Gauge & Head Inserter, 0mm | In distribution | |
| ALIGN, Trial, Radial Stem, 11.0mm | Outer Diameter 11 mm | In distribution |
| ALIGN, Trial, Radial Head, 20mm | Outer Diameter 20 mm | In distribution |
| ALIGN Radial Stem, 12mm x 4mm | In distribution | |
| ALIGN Radial Stem, 11mm x 0mm | Outer Diameter 11 mm | In distribution |
| ALIGN Radial Stem, 12mm x 8mm | In distribution | |
| ALIGN Radial Stem, 6mm x 2mm | In distribution | |
| ALIGN Radial Head & Lock Screw, 22mm | Outer Diameter 22 mm | In distribution |
| ALIGN Radial Head & Lock Screw, 20mm | Outer Diameter 20 mm | In distribution |
| ALIGN, Trial, Radial Stem, 7.0mm | Outer Diameter 7 mm | In distribution |
| ALIGN Radial Stem, 10mm x 2mm | Outer Diameter 10 mm | In distribution |
| ALIGN Radial Head & Lock Screw, 28mm | Outer Diameter 26 mm | In distribution |
| ALIGN Radial Stem, 6mm x 8mm | In distribution | |
| ALIGN Radial Stem, 9mm x 6mm | Outer Diameter 9 mm | In distribution |
| ALIGN Radial Stem, 11mm x 2mm | Outer Diameter 11 mm | In distribution |
| ALIGN Radial Stem, 12mm x 6mm | In distribution | |
| ALIGN Radial Stem, 6mm x 6mm | In distribution | |
| ALIGN, Trial, Radial Neck, 4.0mm | In distribution | |
| ALIGN Radial Stem, 11mm x 6mm | Outer Diameter 11 mm | In distribution |
| ALIGN, Radial Rasp, Stem 10.0mm | Outer Diameter 10 mm | In distribution |
| Trial, Radial Stem, 6.0mm | In distribution | |
| ALIGN Radial Stem, 11mm x 4mm | Outer Diameter 11 mm | In distribution |
| Radial Planer, Stem 12.0mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acumed | Acumed LLC | 175 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes (U.S.A.) LP | 78 |
| Evolve | Wright Medical Technology, Inc. | 75 |
| Rhead | Stryker GmbH | 53 |
| L2L™ | Zimmer, Inc. | 48 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes Gmbh | 43 |
| Explor | Biomet Orthopedics | 32 |
| Avenger | IN2BONES USA, LLC | 32 |
| BioPoly® Radial Head Implant | Biopoly, LLC | 30 |
| Seitz Solution Radial Head | Kapp Surgical Instrument, Inc. | 27 |
| Integra® | Ascension Orthopedics, Inc. | 23 |
| Modular Radial Head (MRH) System | Smith & Nephew, Inc. | 22 |
Showing 12 of 28. All products under Prosthesis, Elbow, Hemi-, Radial, Polymer
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Skeletal Dynamics, Inc | 510(k) number | 2014-10-16 | Class II | Device Design | Report received where the Align Radial Stem fractured. | 1700 | 2016-12-14 |
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.