K233105 is an FDA 510(k) clearance for the RESPONSE? Rib and Pelvic System. This device is classified as a Prosthesis, Rib Replacement (Class II - Special Controls, product code MDI).
Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on January 20, 2024, 115 days after receiving the submission on September 27, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. 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..
| 510(k) Number | K233105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2023 |
| Decision Date | January 20, 2024 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MDI — Prosthesis, Rib Replacement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |
| Definition | 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. |