510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063497Substantially Equivalent

Modification to Scandius Tritis Absorbable Tibial Reconstruction System

Scandius Biomedical, Inc., Littleton MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063497 is the FDA 510(k) clearance record for MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM, a class II device, cleared for Scandius Biomedical, Inc. on under FDA product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue). FDA records list 6 510(k) clearances for Scandius Biomedical, Inc., from to . As of , FDA records show no recalls naming K063497.

Clearance record

Decision date
Received
(29 days to decision)
Product code
MAI Fastener, Fixation, Biodegradable, Soft Tissue
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Scandius Biomedical, Inc. 11a Beaver Brook Rd., Littleton MA
510(k) summary
Summary PDF
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