510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061089Substantially Equivalent

Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599

Biopro, Inc., Port Huron MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K061089 is the FDA 510(k) clearance record for MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599, a class II device, cleared for Biopro, Inc. on under FDA product code KYI (Prosthesis, Wrist, Carpal Trapezium). FDA records list 41 510(k) clearances for Biopro, Inc., from to . As of , FDA records show no recalls naming K061089.

Clearance record

Decision date
Received
(63 days to decision)
Product code
KYI Prosthesis, Wrist, Carpal Trapezium
Regulation
21 CFR 888.3770
Device class
Class II
Review panel
Orthopedic
Applicant
Biopro, Inc. 17 Seventeenth St., Port Huron MI
510(k) summary
Statement
Third party review
No

Clearances, product code KYI

Trailing 12 months

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

FDA records show no clearances under product code KYI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KYI, 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