AFFINITY Proximal Tibia System— 510(k) K220199

Substantially Equivalent

Techfit Digital Surgery, Inc.

FDA 510(k) clearance K220199 for AFFINITY Proximal Tibia System, Substantially Equivalent on 2022-03-21. Applicant: Techfit Digital Surgery, Inc..

Clearance details

Applicant: Techfit Digital Surgery, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2022-01-24
Decision date: 2022-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daytona Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.