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
K112990Substantially Equivalent

Acl Tightrope,acl Tightrope Duuble Bundle

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

K112990 is the FDA 510(k) clearance record for ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE, a class II device, cleared for Arthrex, Inc. on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list 352 510(k) clearances for Arthrex, Inc., from to . As of , FDA records show no recalls naming K112990.

Clearance record

Decision date
Received
(74 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Arthrex, Inc. 1370 Creekside Blvd., Naples FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HTY

Trailing 12 months
2 clearances under product code HTY in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HTY, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260