510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K020043Substantially Equivalent

4.0 Mm Arthrex Bio-Tendoesis Screw, Model Ar-1540B; 5.5 Mm Arthrex Bio-Tenodesis Screw, Models Ar-1555B

Arthrex GmbH, Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020043 is the FDA 510(k) clearance record for 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B, a class II device, cleared for Arthrex, Inc. on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 352 510(k) clearances for Arthrex, Inc., from to . As of , FDA records show no recalls naming K020043.

Clearance record

Decision date
Received
(85 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Arthrex, Inc. 2885 S. Horseshoe Dr., Naples FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HWC

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