510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K021458Substantially Equivalent

Synthes in-Situ Bender/cutter

Synthes (USA) Products LLC, Paoli PA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021458 is the FDA 510(k) clearance record for SYNTHES IN-SITU BENDER/CUTTER, a class II device, cleared for Synthes (Usa) on under FDA product code HRS (Plate, Fixation, Bone). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show 5 recalls naming K021458.

Clearance record

Decision date
Received
(78 days to decision)
Product code
HRS Plate, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Synthes (Usa) 1690 Russell Rd., Paoli PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HRS

Trailing 12 months
59 clearances under product code HRS in the twelve months to October 2026, March 2026 the highest month at 13.
Show the numbers
Monthly 510(k) clearances under FDA product code HRS, trailing twelve months
MonthClearances
November 20255
December 20255
January 20264
February 20265
March 202613
April 20266
May 20262
June 20265
July 20265
August 20263
September 20265
October 20261