510(k) K241999

Prophecy Surgical Planning System by Wright Medical Technology, Inc. (Stryker) — Product Code HSN

K241999 is an FDA 510(k) premarket notification submitted by Wright Medical Technology, Inc. (Stryker) for the device "Prophecy Surgical Planning System". The FDA issued a decision of Substantially Equivalent on November 1, 2024. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Wright Medical Technology, Inc. (Stryker) has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2024
Date Received
July 9, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3110
Review Panel
OR
Submission Type