# K202657: Javelin Tailor's Bunion Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies, Inc.
- Decided: Dec 14, 2020 after 91 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: 13 generations back to K962616 (1996). 229 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152312: RECON system-V-TEK-IVP Plates and Screws, Normed Medizin-Technik GmbH (2015) Summary page 5.
- K190365: Baby Gorilla/Gorilla Plating System, Paragon 28, Inc. (2019) Summary page 5.
- K172148: Anchorage Bone Plating System, Stryker GmbH (2018) Summary page 5.
- K182949: Healix™ Compression Screw System, Nvision Biomedical Technologies, LLC (2018) Summary page 5.
- K161524: Tangis Anterior Cervical Plate, Nvision Biomedical Technologies, LLC (2016) Summary page 5.

## Most influential descendants
- K260291: Vortex5 Tailor's Bunion Correction System (2026), 0 descendants of its own

## Indications for use
The Javelin Tailor's Bunion Fixation System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the foot (such as 5th metatarsal osteotomies for the correction of Tailor's Bunion). The system may be used in both adults and adolescent (13-21 years of age) patients.

Source page: https://510kreport.com/device/K202657
Methodology: https://510kreport.com/methodology