510(k) Report

FDA product code · Orthopedic

Prosthesis, Rib Replacement

MDIClass II21 CFR 888.3070510(k) required2 decisions since 20140 recalls

2 FDA decisions since 2014. 510(k) reviews decided 2021–2025 took a median of 115 days (half between 115 and 115). No recall names this code. The most-cited predicate is K142587, named by 1 later device.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, orthopedic panel

Twenty years of MDI at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · MDI

1in 2024

2014: 12024: 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MDI

Too few MDI 510(k)s in any year since 2007 to give a median.

Recalls per year · MDI

No recall names MDI since 2007.

Adverse event reports per year · MDI

1in 2025

2007: 22008: 162009: 292010: 142011: 382012: 1572013: 782014: 1092015: 1742016: 312017: 642018: 372019: 1362020: 42021: 942022: 272023: 42024: 202025: 1
2007high 174 (2015) · low 1 (2025)2025

MAUDE reports naming product code MDI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20080—016
20090—029
20100—014
20110—038
20120—0157
20130—078
20141—0109
20150—0174
20160—031
20170—064
20180—037
20190—0136
20200—04
20210—094
20220—027
20230—04
20241—020
20250—01
20260—0—
FIG. 1 — MDI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MDI? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do MDI devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc. · 20141cites it

Which MDI devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K233105RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp. · 20247generations
  • K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc. · 20146generations

What has FDA decided in MDI lately?

  • K233105RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp. · 2024
  • K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc. · 20141 recall

All 2 MDI decisions →

Related product codes

Other codes under 21 CFR 888.3070.

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