510(k) · Cleared
Recalled · Class II · 2015Vertical Expandable Prosthetic Titanium Rib
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Synthes Spine, Inc. · MDI Prosthesis, Rib Replacement
Cleared on Nov 18, 2014 as substantially equivalent to K133904 (Medtronic Sofamor Danek USA, 2014) and 1 other predicate after a 64-day review. Its family tree reaches back 6 generations to 2002. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 18, 2014
- Review
- 64 days
- Class
- Class II
- Product code
- MDI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K013962 (2002). 11 ancestors in all, the oldest K922504 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK013962 Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 5 generations backK042453 Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2004
- 4 generations backK042962 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 3 generations backK121764 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2012
- 2 generations backK133904 CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA · 2014
- 1 generation backK141509 Isola and Expedium Growing Spine SystemsMedos Sarl · 2014
- This deviceK142587 Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK233105 RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233105RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K013962 | Equation Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −5 | K042453 | Modification to Equation Fixation System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| −4 | K042962 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −3 | K121764 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2012 | — |
| −2 | K133904 | CD Horizon Spinal System Growth Rod Set | Medtronic Sofamor Danek USA | 2014 | — |
| −1 | K141509 | Isola and Expedium Growing Spine Systems | Medos Sarl | 2014 | — |
| 0 (this device) | K142587 | Vertical Expandable Prosthetic Titanium Rib | Depuy Synthes Spine, Inc. | 2014 | — |
| +1 | K233105 | RESPONSE™ Rib and Pelvic System | OrthoPediatrics Corp. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MDI device
- #1 K233105 RESPONSE™ Rib and Pelvic Systemscore 8.5 · 7 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133904 | CD Horizon Spinal System Growth Rod SetSummary page 5…cement Classification Name: Unclassified Regulation Number: Pre-Amendment Unclassified Primary Predicate Device: Medtronic CD HORIZON® Growth Rod Conversion Set (K133904) Additional Predicate Devices: Medos Sarl ISOLA® and EXPEDIUM® Growing Spine Systems (K141509) Reference Devices: Harr… | 2014 |
| * | K141509 | Isola and Expedium Growing Spine SystemsSummary page 5…mary Predicate Device: Medtronic CD HORIZON® Growth Rod Conversion Set (K133904) Additional Predicate Devices: Medos Sarl ISOLA® and EXPEDIUM® Growing Spine Systems (K141509) Reference Devices: Harrington SpinĂů Rod System (Pre-Amendment), Vertical Expandable Pr… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233105 | RESPONSE™ Rib and Pelvic System | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2015 | Class II | Z-2488-2015 | Process control | The last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to rib sleeve breakage, and may require… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K233105 (OrthoPediatrics Corp., 2024) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K133904.
How does its category compare?
All MDI devicesMDI Prosthesis, Rib Replacement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MDI
1in 2024
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
MAUDE reports naming product code MDI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 16 |
| 2009 | 0 | — | 0 | 29 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 38 |
| 2012 | 0 | — | 0 | 157 |
| 2013 | 0 | — | 0 | 78 |
| 2014 | 1 | — | 0 | 109 |
| 2015 | 0 | — | 0 | 174 |
| 2016 | 0 | — | 0 | 31 |
| 2017 | 0 | — | 0 | 64 |
| 2018 | 0 | — | 0 | 37 |
| 2019 | 0 | — | 0 | 136 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 94 |
| 2022 | 0 | — | 0 | 27 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VEPTR/VEPTR II device is indicated for skeletally immature patients with severe, progressive spinal deformities and/or three dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth. This would include patients with progressive congenital, neuromuscular, idiopathic, or syndromic scoliosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142587: Vertical Expandable Prosthetic Titanium Rib.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142587
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026