510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142587Substantially Equivalent

Vertical Expandable Prosthetic Titanium Rib

Depuy Synthes Spine, Raynham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142587 is the FDA 510(k) clearance record for Vertical Expandable Prosthetic Titanium Rib, a class II device, cleared for Depuy Synthes Spine, Inc. on under FDA product code MDI (Prosthesis, Rib Replacement). FDA's definition for product code MDI reads: "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...". FDA records list 3 510(k) clearances for Depuy Synthes Spine, Inc., from to . As of , FDA records show one recall naming K142587.

Clearance record

Decision date
Received
(64 days to decision)
Product code
MDI Prosthesis, Rib Replacement
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Depuy Synthes Spine, Inc. 325 Paramount Dr., Raynham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MDI

Trailing 12 months

FDA records hold no clearances under product code MDI in the trailing twelve months.

FDA records show no clearances under product code MDI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MDI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260