510(k) · Cleared
ClearedRESPONSE™ Rib and Pelvic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OrthoPediatrics Corp. · MDI Prosthesis, Rib Replacement
Cleared on Jan 20, 2024 as substantially equivalent to K142587 (Depuy Synthes Spine, Inc., 2014) and 1 other predicate after a 115-day review. Its family tree reaches back 7 generations to 2002.
- Decided
- Jan 20, 2024
- Review
- 115 days
- Class
- Class II
- Product code
- MDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K013962 (2002). 13 ancestors in all, the oldest K922504 (1993). No later device cites it as a predicate yet.
- Root · 7 generations backK013962 Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 6 generations backK042453 Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2004
- 5 generations backK042962 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK121764 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2012
- 3 generations backK133904 CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA · 2014
- 2 generations backK141509 Isola and Expedium Growing Spine SystemsMedos Sarl · 2014
- 1 generation backK142587 Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc. · 2014 · Recalled
- This deviceK233105 RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K013962 | Equation Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −6 | K042453 | Modification to Equation Fixation System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| −5 | K042962 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K121764 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2012 | — |
| −3 | K133904 | CD Horizon Spinal System Growth Rod Set | Medtronic Sofamor Danek USA | 2014 | — |
| −2 | K141509 | Isola and Expedium Growing Spine Systems | Medos Sarl | 2014 | — |
| −1 | K142587 | Vertical Expandable Prosthetic Titanium Rib | Depuy Synthes Spine, Inc. | 2014 | 1 |
| 0 (this device) | 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 |
| 2018 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K142587 | Vertical Expandable Prosthetic Titanium RibSummary page 4…evice Substantial equivalence is claimed to the following predicate device: Primary Predicate Device: • Vertical Expandable Prosthetic Titanium Rib (K142587*, Depuy Synthes Spine, Inc.) *The HDE H030009 is superseded by the 510(k) K142587 Additional Predicate Device:… | 2014 |
| * | K180227 | Polaris Spinal Growth SystemSummary page 4…uy Synthes Spine, Inc.) *The HDE H030009 is superseded by the 510(k) K142587 Additional Predicate Device: • Polaris Spinal Growth System (K180227, Zimmer Biomet Spine, Inc.) OrthoPediatrics, Corp. K233105… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 13 ancestors have a recall of any class.
How does its category compare?
All MDI devicesMDI Prosthesis, Rib Replacement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 RESPONSE™ Rib and Pelvic System is indicated for skeletally immature patients with severe, progressive spinal deformities such as congenital scoliosis, neuromuscular scoliosis, idiopathic scoliosis, syndromic scoliosis and/or three-dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233105: RESPONSE™ Rib and Pelvic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233105
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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