510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K940389Substantially Equivalent for Some Indications

S.t.e.p. Uni-Knee

S.T.E.P. Orthopaedics, Inc., Waterford WI / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K940389 is the FDA 510(k) clearance record for S.T.E.P. UNI-KNEE, a class II device, cleared for S.T.E.P. Orthopaedics, Inc. on under FDA product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer). FDA records list one 510(k) clearance for S.T.E.P. Orthopaedics, Inc. As of , FDA records show no recalls naming K940389.

Clearance record

Decision date
Received
(358 days to decision)
Product code
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3530
Device class
Class II
Review panel
Orthopedic
Applicant
S.T.E.P. Orthopaedics, Inc. 711a Aber Ct., Waterford WI
Third party review
No

Clearances, product code HRY

Trailing 12 months

FDA records hold no clearances under product code HRY in the trailing twelve months.

FDA records show no clearances under product code HRY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HRY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260