510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K121989Substantially Equivalent

Optecure Bone Void Filler (0.5 Cc, 1Cc, 2Cc, 5Cc, 10Cc, and 20Cc), Optecure + Ccc Bone Void Filler (1Cc, 2Cc, 5Cc, 10Cc,

Exactech, Inc., Gainesville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121989 is the FDA 510(k) clearance record for OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,, a class II device, cleared for Exactech, Inc. on under FDA product code MQV (Filler, Bone Void, Calcium Compound). FDA records list 186 510(k) clearances for Exactech, Inc., from to . As of , FDA records show no recalls naming K121989.

Clearance record

Decision date
Received
(144 days to decision)
Product code
MQV Filler, Bone Void, Calcium Compound
Regulation
21 CFR 888.3045
Device class
Class II
Review panel
Orthopedic
Applicant
Exactech, Inc. 2320 NW 66th Ct., Gainesville FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQV

Trailing 12 months
5 clearances under product code MQV in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQV, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20260
April 20261
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260
November 20260