# K233105: RESPONSE™ Rib and Pelvic System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Jan 20, 2024 after 115 days
- Product code: MDI (Prosthesis, Rib Replacement)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K013962 (2002). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142587: Vertical Expandable Prosthetic Titanium Rib, Depuy Synthes Spine, Inc. (2014) Summary page 4.
- K180227: Polaris Spinal Growth System, Zimmer Biomet Spine, Inc. (2018) Summary page 4.

## Indications for use
The RESPONSE™ Rib and Pelvic System is indicated for skeletally immature patients with severe, progressive spinal deformities such as congenital scoliosis, neuromuscular scoliosis, idiopathic scoliosis, syndromic scoliosis and/or three-dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS).

Source page: https://510kreport.com/device/K233105
Methodology: https://510kreport.com/methodology