510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063499Substantially Equivalent

Modification to Scandius Tritis Tibial Acl Reconstruction System

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

K063499 is the FDA 510(k) clearance record for MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM, a class II device, cleared for Scandius Biomedical, Inc. on under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). FDA records list 6 510(k) clearances for Scandius Biomedical, Inc., from to . As of , FDA records show no recalls naming K063499.

Clearance record

Decision date
Received
(29 days to decision)
Product code
MBI Fastener, Fixation, Nondegradable, Soft Tissue
Regulation
21 CFR 888.3040
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 MBI

Trailing 12 months
31 clearances under product code MBI in the twelve months to October 2026, March 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code MBI, trailing twelve months
MonthClearances
November 20251
December 20252
January 20263
February 20261
March 20269
April 20261
May 20264
June 20261
July 20264
August 20262
September 20263
October 20260