510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203634Substantially Equivalent

BioPoly Great Toe Hemiarthroplasty Implant

Biopoly, LLC, Fort Wayne IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203634 is the FDA 510(k) clearance record for BioPoly Great Toe Hemiarthroplasty Implant, a class II device, cleared for BioPoly, LLC on under FDA product code KWD (Prosthesis, Toe, Hemi-, Phalangeal). FDA records list 3 510(k) clearances for BioPoly, LLC, from to . As of , FDA records show no recalls naming K203634.

Clearance record

Decision date
Received
(53 days to decision)
Product code
KWD Prosthesis, Toe, Hemi-, Phalangeal
Regulation
21 CFR 888.3730
Device class
Class II
Review panel
Orthopedic
Applicant
BioPoly, LLC 7136 Gettysburg Pike, Fort Wayne IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWD

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