AFFINITY Proximal Tibia System

510(k) Number

K220199 ↗

FDA product code

HRS

Device class

Class II

Regulation

21 CFR Part 888.3030

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code HRS (Plate, Fixation, Bone).

• Arthrex® AR-8827-52 by Arthrex, Inc.
• CALCANEAL FRACTURE PLATE SYSTEM by TORNIER, INC.
• PCFB-118S by TDM Co., Ltd.
• ACUMED 7007-0109L-S by ACUMED LLC
• 2357-10-06 00-2357-010-06 by Zimmer, Inc.
• PCFB-212 by TDM Co., Ltd.
• Arthrex® AR-8935L-46S by Arthrex, Inc.
• Piccolo Composite Plate System Diaphyseal Plate - Narrow PLCNN4509 by CARBOFIX ORTHOPEDICS LTD
• MULTIDIRECTIONAL SCREW 8163-35-010 816335010 by Biomet Orthopedics, Inc.
• ACUMED 70-0359 by ACUMED LLC

• TECHFIT DISRP® System

  Class II

  FDA 510(k) K230276 Active Cleared 23 Jun 2023

• TECHFIT Diagnostic Models

  Class II

  FDA 510(k) K222577 Active Cleared 6 Jan 2023

• TECHFIT Patient-Specific Cranial System

  Class II

  FDA 510(k) K250297 Active Cleared 27 Oct 2025

• TECHFIT DISRP® System

  Class II

  FDA 510(k) K242263 Active Cleared 11 Dec 2024