VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH.— 510(k) K821340

Name: FDA 510(k) clearance K821340
Creator: U.S. Food and Drug Administration
Published: 1982-05-27

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K821340 for VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH., Substantially Equivalent on 1982-05-27. Applicant: Intermedics Orthopedics. Device class: 2.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code KRO
Device class: Class 2
Regulation: 21 CFR 888.3510
Advisory panel: Orthopedic
Date received: 1982-05-05
Decision date: 1982-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRO

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K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System2026-08-06
K252898 — Triathlon® Tritanium® Asymmetric Patella +5 more2025-12-15
K252303 — Stem Extension Line (USTAR II System)2025-08-22
K251665 — Triathlon® Hinge Knee System2025-07-25
K242871 — ATTUNE Revision Hinge Knee2024-11-21

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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 KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.