510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K060180Substantially Equivalent

Bioset Xc

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Alachua FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060180 is the FDA 510(k) clearance record for BIOSET XC, a class II device, cleared for Regeneration Technologies, Inc. on under FDA product code MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)). FDA records list 100 510(k) clearances for RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), from to . As of , FDA records show no recalls naming K060180.

Clearance record

Decision date
Received
(226 days to decision)
Product code
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Regulation
21 CFR 888.3045
Device class
Class II
Review panel
Orthopedic
Applicant
Regeneration Technologies, Inc. 11621 Research Cir., Alachua FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBP

Trailing 12 months

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

FDA records show no clearances under product code MBP in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MBP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260