510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K892228Substantially Equivalent

Intermedics High Tibial Osteotomy System

Intermedics Orthopedics, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892228 is the FDA 510(k) clearance record for INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM, a class II device, cleared for Intermedics Orthopedics on under FDA product code HRS (Plate, Fixation, Bone). FDA records list 108 510(k) clearances for Intermedics Orthopedics, from to . As of , FDA records show no recalls naming K892228.

Clearance record

Decision date
Received
(184 days to decision)
Product code
HRS Plate, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Intermedics Orthopedics 1300 E. Anderson Ln., Austin TX
Third party review
No

Clearances, product code HRS

Trailing 12 months
55 clearances under product code HRS in the twelve months to November 2026, March 2026 the highest month at 13.
Show the numbers
Monthly 510(k) clearances under FDA product code HRS, trailing twelve months
MonthClearances
December 20255
January 20264
February 20265
March 202613
April 20266
May 20262
June 20265
July 20265
August 20263
September 20265
October 20262
November 20260