510(k) · Cleared
ClearedDaytona® Small Stature Growth Rod Conversion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SeaSpine Orthopedics Corporation · PGM Growing Rod System
Cleared on Feb 13, 2020 as substantially equivalent to K142114 (Stryker Corporation, 2014) after an 83-day review. Its family tree reaches back 6 generations to 2002. 2 later devices descend from it.
- Decided
- Feb 13, 2020
- Review
- 83 days
- Class
- Class II
- Product code
- PGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K013962 (2002). 8 ancestors in all, the oldest K961633 (1996). 2 later devices descend 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 backK142114 Xia® Growth Rod Conversion SetStryker Corporation · 2014
- This deviceK193224 Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics Corporation · 2020
- Descendant · cites it directly · 1 of its ownK232566 NewPort Spinal System; Daytona Small Stature Spinal System; Malibu…SeaSpine Orthopedics Corporation · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK253420 Admiral ACP System; Explorer TO System; Laminoplasty System; Manta…SeaSpine Orthopedics Corporation · 2026
Most influential descendants
Showing 2 of 2 · See all- K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation · 2024 · cites it directly1descendant
- K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation · 2026 · 2 generations on0descendants
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 | K142114 | Xia® Growth Rod Conversion Set | Stryker Corporation | 2014 | — |
| 0 (this device) | K193224 | Daytona® Small Stature Growth Rod Conversion Set | SeaSpine Orthopedics Corporation | 2020 | — |
| +1 | K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal… | SeaSpine Orthopedics Corporation | 2024 | 2 |
| +2 | K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF… | SeaSpine Orthopedics Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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 PGM? 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 PGM device
- #1 K251961 SDS Growing Rodscore 12.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K142114 | Xia® Growth Rod Conversion SetSummary page 5…umber Product Code Trade Name Manufacturer PRIMARY PREDICATE Device Xia® Growth Rod K142114 PGM Stryker Corporation Conversion… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System… | 2024 | 1 |
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 18 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K232566 (SeaSpine Orthopedics Corporation, 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K142114.
How does its category compare?
All PGM devicesPGM Growing Rod System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PGM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGM
81in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGM
No recall names PGM since 2007.
Adverse event reports per year · PGM
7in 2025
MAUDE reports naming product code PGM, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 4 | 81 | 0 | 5 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 7 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Daytona® Small Stature Growth Rod Conversion Set is indicated in patients under 10 years of age with potential for additional spinal growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The extended axial connectors may be used with any cleared Daytona® Small Stature Spinal System rod construct. The Daytona® Small Stature Growth Rod Conversion Set is not intended to be used in conjunction with staples.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193224: Daytona® Small Stature Growth Rod Conversion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193224
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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