# K220199: AFFINITY Proximal Tibia System

- Pathway: 510(k) (Traditional)
- Applicant: Techfit Digital Surgery, Inc.
- Decided: Mar 21, 2022 after 56 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K792022 (1979). 172 ancestors in all.
No later device cites it as a predicate yet.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132554: Aap Loqteq Proximal Medial Tibia Plate 3.5, Aap Implantate AG (2013) Summary page 4.
- K171808: TDM Plate and Screw System, Tdm Co., Ltd. (2018) Summary page 4.
- K191641: AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws, Industrias Medicas Sampedro S.A.S (2019) Summary page 5.
- K203282: TECHFIT Patient-Specific Maxillofacial System, Industrias Medicas Sampedro S.A.S (2021) Summary page 5.
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 5.
- K123964: Axsos 3 TI Locking Plate System, Stryker Trauma AG (2013) Summary page 5.

## Indications for use
AFFINITY Proximal Tibia System is intended to treat fractures, nonunions, malunions of the proximal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Simple metaphyseal fractures (Classification AO 41-A2) Multifragmentary metaphyseal fractures (Classification AO 41-A3) Simple bicondylar fractures (Classification AO41-C1, 41-C2) Multifragmentary bicondylar fractures (Classification AO 41-C3) Simple joint, simple metaphyseal fractures (Classification AO 41-C1) Diaphisary fractures (Classification AO 42A and 42B)

Source page: https://510kreport.com/device/K220199
Methodology: https://510kreport.com/methodology