510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073303Unknown

Norian Drillable

Synthes (USA) Products LLC, West Chester PA / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073303 is the FDA 510(k) clearance record for NORIAN DRILLABLE, a class II device, cleared for Synthes (Usa) on under FDA product code OIS (Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation). FDA's definition for product code OIS reads: "To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure. It is delivered to the defect and resorbs over time to be replaced by bone. Not for screw augmentation". FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show 3 recalls naming K073303.

Clearance record

Decision date
Received
(222 days to decision)
Product code
OIS Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
Regulation
21 CFR 888.3045
Device class
Class II
Review panel
Orthopedic
Applicant
Synthes (Usa) 1230 Wilson Dr., West Chester PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OIS

Trailing 12 months

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

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