510(k) · Cleared
ClearedAaxter A3 Posterior Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aaxter Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Mar 16, 2011 as substantially equivalent to K031595 (U&I Corp., America, 2003) after a 303-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Mar 16, 2011
- Review
- 303 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K884263 (1988). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK884263 Rogozinski Spinal SystemRichards Medical Co., Inc. · 1988
- 2 generations backK983904 Rogozinski Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998
- 1 generation backK031595 U & I America Spinal Hook SystemU&I Corp., America · 2003 · Recalled
- This deviceK101374 Aaxter A3 Posterior Spinal SystemAaxter Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884263 | Rogozinski Spinal System | Richards Medical Co., Inc. | 1988 | — |
| −2 | K983904 | Rogozinski Spinal Rod System | United States Surgical, A Division of Tyco Healthc | 1998 | — |
| −1 | K031595 | U & I America Spinal Hook System | U&I Corp., America | 2003 | 3 |
| 0 (this device) | K101374 | Aaxter A3 Posterior Spinal System | Aaxter Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 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 MNH? 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? (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 |
|---|---|---|---|
| * | K031595 | U & I America Spinal Hook SystemSummary page 2…ivalent in function materials, design, operational principles, composition, labeling, and intended use to: TMM U&J Ame'ica, Spinal Hook SystemT M , KWP-(K03 1595) Device Description: The Aaxter A3 Posterior Spinal System is a posterior spinal system which is a top loading multiple compo… | 2003 |
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 23 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 2 other devices also cite its predicate K031595.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Aaxter A3 Posterior Spinal System is intended for posterior pedicle and non-pedicle fixation in the non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indication; spondylolisthesis (Grade 3 and 4), of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft having implants attainment to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.…
Read the full statement (136 words)
The Aaxter A3 Posterior Spinal System is intended for posterior pedicle and non-pedicle fixation in the non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indication; spondylolisthesis (Grade 3 and 4), of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft having implants attainment to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.
In addition, the Aaxter A3 Posterior Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
"Degenerative spondylolisthesis with objective evidence of neurological impairment
* Fracture of the vertebral body
* Dislocation
- Scoliosis
* Kyphosis
"Spinal tumnor
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101374: Aaxter A3 Posterior Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101374
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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