# K210290: JACE Medical Thoracic Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Jace Medical, LLC
- Decided: Apr 30, 2021 after 87 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: 12 generations back to K761228 (1976). 91 ancestors in all.
No later device cites it as a predicate yet.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121302: Biomet Microfixation Sternal Closure System, Biomet Microfixation (2012) Summary page 4.
- K142484: Sternal Closure System, Jace Medical, LLC (2014) Summary page 4.
- K170767: Surgical Stainless Steel Suture, Stainless Steel Suture, ETHICON, Inc. (2017) Summary page 4.

## Indications for use
The JACE Medical Thoracic Plating System is indicated for use in the stabilization and fixation of fractures of the chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, trauma, or planned osteotomies.

Source page: https://510kreport.com/device/K210290
Methodology: https://510kreport.com/methodology