510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K102549Substantially Equivalent

The Ascension Movement Great Toe System Total Arthroplasty

Ascension Orthopedics, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102549 is the FDA 510(k) clearance record for THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY, cleared for Ascension Orthopedics, Inc. on under FDA product code LZJ (Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained). FDA records list 29 510(k) clearances for Ascension Orthopedics, Inc., from to . As of , FDA records show no recalls naming K102549.

Clearance record

Decision date
Received
(105 days to decision)
Product code
LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Device class
Unclassified
Review panel
Unknown
Applicant
Ascension Orthopedics, Inc. 8700 Cameron Rd., Suite 100, Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZJ

Trailing 12 months

FDA records hold no clearances under product code LZJ in the trailing twelve months.

FDA records show no clearances under product code LZJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LZJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260