Cleared Traditional

K233105 - RESPONSE™ Rib and Pelvic System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233105 · OrthoPediatrics Corp. · Orthopedic device
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Jan 2024
Decision
115d
Days
Class 2
Risk

K233105 is an FDA 510(k) clearance for the RESPONSE™ Rib and Pelvic System. Classified as Prosthesis, Rib Replacement (product code MDI), Class II - Special Controls.

Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on January 20, 2024 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all OrthoPediatrics Corp. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 122d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MDI Prosthesis, Rib Replacement
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.