KNEE SYSTEM, QUADRAXIAL CONSTRAINED— 510(k) K781971

Name: FDA 510(k) clearance K781971
Creator: U.S. Food and Drug Administration
Published: 1979-04-04

Substantially Equivalent

Hexcel Medical

FDA 510(k) clearance K781971 for KNEE SYSTEM, QUADRAXIAL CONSTRAINED, Substantially Equivalent on 1979-04-04. Applicant: Hexcel Medical. Device class: 2.

Clearance details

Applicant: Hexcel Medical
Product code: Code KRO
Device class: Class 2
Regulation: 21 CFR 888.3510
Advisory panel: Orthopedic
Date received: 1978-11-27
Decision date: 1979-04-04
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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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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K840416 — HEXCELITE1984-03-23
K820890 — URETHANE ORTHOPAEDIC CASTING TAPE1982-06-23
K812669 — SEATTLE II TOTAL HIP SYSTEM1981-10-02
K812687 — BRIGHAM II TOTAL HIP SYSTEM1981-10-02
K812068 — PROPOSED CONTROLS FOR DOSIMETRIC RELEASE1981-09-08

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.