Cleared Traditional

K142587 - Vertical Expandable Prosthetic Titanium Rib (FDA 510(k) Clearance)

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

K142587 · Depuy Synthes Spine, Inc. · Orthopedic device
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Nov 2014
Decision
64d
Days
Class 2
Risk

K142587 is an FDA 510(k) clearance for the Vertical Expandable Prosthetic Titanium Rib. Classified as Prosthesis, Rib Replacement (product code MDI), Class II - Special Controls.

Submitted by Depuy Synthes Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on November 18, 2014 after a review of 64 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy Synthes Spine, Inc. devices

Submission Details

510(k) Number K142587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2014
Decision Date November 18, 2014
Days to Decision 64 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 122d · This submission: 64d
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.