510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202815Substantially Equivalent

PROPHECY Preoperative Navigation Alignment System

Wrightmedicaltechnologyinc, Bloomington MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202815 is the FDA 510(k) clearance record for PROPHECY Preoperative Navigation Alignment System, a class II device, cleared for Wrightmedicaltechnologyinc on under FDA product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer). FDA records list 302 510(k) clearances for Wrightmedicaltechnologyinc, from to . As of , FDA records show no recalls naming K202815.

Clearance record

Decision date
Received
(167 days to decision)
Product code
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3110
Device class
Class II
Review panel
Orthopedic
Applicant
Wrightmedicaltechnologyinc 10801 Nesbitt Ave. S., Bloomington MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HSN

Trailing 12 months
1 clearance under product code HSN in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HSN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260