510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K991197Substantially Equivalent

Vilex/duval/orthex Cannulated Bone Screw, Models P222-Xx, S25-Xx, P227-Xx, S30-Xx, P235-Xx, S35-Xx, P240-Xx, S40-Xx, P24

Vilex, Inc., Jefferson Hills PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991197 is the FDA 510(k) clearance record for VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24, a class II device, cleared for Vilex, Inc. on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 2 510(k) clearances for Vilex, Inc. As of , FDA records show no recalls naming K991197.

Clearance record

Decision date
Received
(19 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Vilex, Inc. 1801 Rt. 51, Bldg. 10, Jefferson Hills PA
510(k) summary
Statement
Third party review
No

Clearances, product code HWC

Trailing 12 months
22 clearances under product code HWC in the twelve months to October 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code HWC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20262
April 20263
May 20264
June 20262
July 20261
August 20263
September 20264
October 20261