510(k) · Cleared
ClearedPolaris Spinal Growth System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Biomet Spine, Inc. · PGM Growing Rod System
Cleared on Mar 15, 2018 as substantially equivalent to K133904 (Medtronic Sofamor Danek USA, 2014) after a 48-day review. Its family tree reaches back 5 generations to 2002. 1 later device descends from it.
- Decided
- Mar 15, 2018
- Review
- 48 days
- Class
- Class II
- Product code
- PGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K013962 (2002). 7 ancestors in all, the oldest K961633 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK013962 Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 4 generations backK042453 Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2004
- 3 generations backK042962 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 2 generations backK121764 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2012
- 1 generation backK133904 CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA · 2014
- This deviceK180227 Polaris Spinal Growth SystemZimmer Biomet Spine, Inc. · 2018
- 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 |
|---|---|---|---|---|---|
| −5 | K013962 | Equation Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −4 | K042453 | Modification to Equation Fixation System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| −3 | K042962 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −2 | K121764 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2012 | — |
| −1 | K133904 | CD Horizon Spinal System Growth Rod Set | Medtronic Sofamor Danek USA | 2014 | — |
| 0 (this device) | K180227 | Polaris Spinal Growth System | Zimmer Biomet Spine, Inc. | 2018 | — |
| +1 | K233105 | RESPONSE™ Rib and Pelvic System | OrthoPediatrics Corp. | 2024 | — |
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 |
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 |
|---|---|---|---|
| * | K133904 | CD Horizon Spinal System Growth Rod SetSummary page 6…, the Polaris Spinal Growth System functioned as intended, meeting the acceptance criteria. Predicate Devices: Predicate Device: CD Horizon® Growth Rod Conversion Set (K133904) Reference Device: Polaris Spinal System (K151974) Substantial Equivalence Conclusion: The Polaris Spinal Growth System is subs… | 2014 |
| † | K151974 | Polaris Spinal System | 2015 |
| † | K133746 | Polaris Spinal System | 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)
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 16 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 7 ancestors has a recall.
- 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 PGM devicesPGM Growing Rod System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Polaris Spinal Growth System is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome.
The Polaris Spinal Growth System may be used with any cleared traditional Polaris Spinal System construct, including any cleared Polaris Spinal System compatibilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180227: Polaris Spinal Growth System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180227
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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