METS MODULAR DISTAL FEMUR— 510(k) K121029

Name: FDA 510(k) clearance K121029
Creator: U.S. Food and Drug Administration
Published: 2012-09-19

Substantially Equivalent

Stanmore Implants Worldwide , Ltd.

FDA 510(k) clearance K121029 for METS MODULAR DISTAL FEMUR, Substantially Equivalent on 2012-09-19. Applicant: Stanmore Implants Worldwide , Ltd.. Device class: 2.

Clearance details

Applicant: Stanmore Implants Worldwide , Ltd.
Product code: Code KRO
Device class: Class 2
Regulation: 21 CFR 888.3510
Advisory panel: Orthopedic
Date received: 2012-04-05
Decision date: 2012-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canton, MA, US

Download summary PDF View on FDA.gov ↗

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K121765 — SCULPTOR ROBOTIC GUIDANCE ARM (RGA)2013-01-11
K121056 — METS MODULAR PROXIMAL FEMUR2012-09-20
K121055 — METS MODULAR TOTAL FEMUR2012-09-19

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.