AFFINITY Proximal Tibia System

FDA 510(k) K220199 · Techfit Digital Surgery, Inc.

Substantially Equivalent

510(k) numberK220199

Submission

Device name
AFFINITY Proximal Tibia System
Applicant
Techfit Digital Surgery, Inc.
Daytona Beach, FL, US
Received
January 24, 2022
Decision date
March 21, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HRS – Plate, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code HRS

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K261647Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional Pace Surgical09/03/2026SE
K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional Ortler Global Tibbi Gerecler Anonim Sirketi08/28/2026SE
K262537Versalock Sterile Plating SystemHRS · Special GM Dos Reis Industria e Comercio Ltda.08/19/2026SE
K260277Mikron Trauma Bone Plate& Screw SystemHRS · Traditional Mikron Makina San. ve Tic. Ltd. Sti.08/13/2026SE
K261511Xpert AnkleHRS · Traditional Newclip Technics07/28/2026SE
K261406Versalock Proximal Tibial Plating SystemHRS · Traditional GM Dos Reis Industria e Comercio Ltda.07/21/2026SE
K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special TriMed, Inc.07/16/2026SE
K261191Alians Elbow SHRS · Traditional Newclip Technics07/08/2026SE
K261054RibPlate SystemHRS · Traditional Stryker Leibinger GmbH & Co KG07/01/2026SE
K261351SALGINA 2.5mm Distal Radius SystemHRS · Traditional Bonebridge AG06/26/2026SE

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Questions and answers

When was AFFINITY Proximal Tibia System cleared by the FDA?

AFFINITY Proximal Tibia System (K220199) received a 510(k) decision of Substantially Equivalent on March 21, 2022, 56 days after the submission was received.

What is the product code of K220199?

The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.