Prosthesis, Rib Replacement

FDA product code MDI · Class II (moderate risk) · 21 CFR 888.3070 · Orthopedic

In children with or at risk of developing Thoracic Insufficiency Syndrome, the expandable rib prosthesis devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. The devices are attached perpendicularly to the subject's natural ribs and lumbar vertebra or pelvis. This mechanically stabilizes the chest wall and enlarges the thorax to improve respiration and lung growth. The devices allow assembly in a number of different configurations to accommodate the wide variety of anatomical deformities encountered by the clinician in treating patients with or at risk of developing Thoracic Insufficiency Syndrome.

2510(k) clearances
0PMA approvals
1recalls
Implantimplanted device

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K233105RESPONSE™ Rib and Pelvic SystemMDI · Traditional OrthoPediatrics Corp.01/20/2024SE
K142587Vertical Expandable Prosthetic Titanium RibMDI · Traditional Depuy Synthes Spine, Inc.11/18/2014SE

Recalls

RecallProductFirmInitiated
Z-2488-2015 Class IIVEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal…The last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the construct to… Synthes (USA) Products LLC07/29/2015Terminated