Class Class II
Metal Cannulated Screw (K221090)
Description
Metal Cannulated Screw by Double Medical Technology, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221090
Clearance Date2023-01-10
Clearance TypeTraditional
Product CodeHWC
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221090
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Metal Cannulated Screw (K221090) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182361 | Arthrex Compression FT Screws | Arthrex, Inc. | 2018 |
| K170382 | Arthrex Compression Screws | Arthrex, Inc. | 2017 |
| K162353 | MICATM Screw System | Wrightmedicaltechnologyinc | 2017 |
| K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthe... | Synthes USA Products, LLC | 2017 |
| K143229 | Nexis osteosynthesis compressive screws | Novastep | 2015 |
| K130108 | DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS | Xiamen Double Engine Medical Materi... | 2013 |
Trace the full predicate network for K221090
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.