S.T.E.P. UNI-KNEE— 510(k) K940389

Name: FDA 510(k) clearance K940389
Creator: U.S. Food and Drug Administration
Published: 1995-01-19

Substantially Equivalent for Some Indications

S.T.E.P. Orthopaedics, Inc.

FDA 510(k) clearance K940389 for S.T.E.P. UNI-KNEE, Substantially Equivalent for Some Indications on 1995-01-19. Applicant: S.T.E.P. Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: S.T.E.P. Orthopaedics, Inc.
Product code: Code HRY
Device class: Class 2
Regulation: 21 CFR 888.3530
Advisory panel: Orthopedic
Date received: 1994-01-26
Decision date: 1995-01-19
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Waterford, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRY

view all

K193549 — SIGMA High Performance (HP) Partial Knee System2020-04-16
K190633 — NanoOrtho NanoKnee® System2019-12-20
K152631 — MPO Total Knee Systems MR Labeling2016-03-23
K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM2015-03-20
K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)2014-03-28

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.