Class Class II
Prophecy Preoperative Navigation Alignment System (K222835)
Description
Prophecy Preoperative Navigation Alignment System by Wrightmedicaltechnologyinc, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222835
Clearance Date2023-01-27
Clearance TypeTraditional
Product CodeHSN
Regulation Number888.3110
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222835
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. Prophecy Preoperative Navigation Alignment System (K222835) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 |
| K202815 | PROPHECY Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241999 | Prophecy Surgical Planning System | Wright Medical Technology, Inc. (St... | 2024 |
Trace the full predicate network for K222835
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.