510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K111843Substantially Equivalent

Acufex Director Application Anatomic Guide System

Smith & Nephew, Inc., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111843 is the FDA 510(k) clearance record for ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM, a class II device, cleared for Smith & Nephew Inc., Endoscopy Div. on under FDA product code OLO (Orthopedic Stereotaxic Instrument). FDA's definition for product code OLO reads: "Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW". FDA records list 572 510(k) clearances for SMITH & NEPHEW INC., from to . As of , FDA records show no recalls naming K111843.

Clearance record

Decision date
Received
(138 days to decision)
Product code
OLO Orthopedic Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Smith & Nephew Inc., Endoscopy Div. 150 Minuteman Rd., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLO

Trailing 12 months
46 clearances under product code OLO in the twelve months to November 2026, February 2026 the highest month at 10.
Show the numbers
Monthly 510(k) clearances under FDA product code OLO, trailing twelve months
MonthClearances
December 20254
January 20262
February 202610
March 20267
April 20262
May 20265
June 20265
July 20266
August 20261
September 20261
October 20263
November 20260