510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001378Substantially Equivalent

Biocuff, Models 225718, 225728, 225736, 235718, 235728, 235736

Bionx Implants, Inc., Tampere, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001378 is the FDA 510(k) clearance record for BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736, a class II device, cleared for Bionx Implants, Inc. on under FDA product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue). FDA records list 30 510(k) clearances for Bionx Implants, Inc., from to . As of , FDA records show no recalls naming K001378.

Clearance record

Decision date
Received
(88 days to decision)
Product code
MAI Fastener, Fixation, Biodegradable, Soft Tissue
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Bionx Implants, Inc. Hermiankatu 6-8 L, Tampere, FI
510(k) summary
Summary
Third party review
No

Clearances, product code MAI

Trailing 12 months
5 clearances under product code MAI in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MAI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260