IOI METAL BACKED TIBIAL COMPONENT— 510(k) K821341

Name: FDA 510(k) clearance K821341
Creator: U.S. Food and Drug Administration
Published: 1982-06-03

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K821341 for IOI METAL BACKED TIBIAL COMPONENT, Substantially Equivalent on 1982-06-03. Applicant: Intermedics Orthopedics. Device class: 2.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code HRY
Device class: Class 2
Regulation: 21 CFR 888.3530
Advisory panel: Orthopedic
Date received: 1982-05-05
Decision date: 1982-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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

More clearances from Intermedics Orthopedics

view all

K970300 — NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI1997-07-03
K970498 — NATURAL-KNEE II REVISION FEMORAL SPACER LUGS1997-04-30
K970166 — NATURAL-HIP SYSTEM COCR REVISION STEM1997-04-08
K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS1997-02-27
K964357 — NATURAL-HIP SYSTEM COCR STEM1997-01-27

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.