510(k) · Cleared
ClearedAnax 5.5 Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&I Corporation · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Nov 25, 2013 as substantially equivalent to K011437 (Interpore Cross Intl., 2001) and 2 other predicates after a 140-day review. Its family tree reaches back 5 generations to 2000. 13 later devices descend from it.
- Decided
- Nov 25, 2013
- Review
- 140 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K000319 (2000). 12 ancestors in all. 13 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 4 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 3 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 2 generations backK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- 1 generation backK100765 Fixpine II SystemDio Medical Co., Ltd. · 2010
- This deviceK132101 Anax 5.5 Spinal SystemU&I Corporation · 2013
- Descendant · cites it directly · 6 of its ownK160731 LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
- Descendant · cites it directly · 4 of its ownK143417 ANAX 5.5 Spinal SystemU&I Corporation · 2015
- Descendant · cites it directly · 3 of its ownK162189 ANAX™ 5.5 Spinal SystemU&I Corporation · 2016
- Descendant · 2 generations on · 2 of its ownK222229 Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK173524 ANAX 5.5™ Spinal SystemU&I Corporation · 2017 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016 · cites it directly6descendants
- K143417ANAX 5.5 Spinal SystemU&I Corporation · 2015 · cites it directly4descendants
- K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016 · cites it directly3descendants
- K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023 · 2 generations on2descendants
- K173524ANAX 5.5™ Spinal SystemU&I Corporation · 2017 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −4 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −3 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −2 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| −1 | K100765 | Fixpine II System | Dio Medical Co., Ltd. | 2010 | — |
| 0 (this device) | K132101 | Anax 5.5 Spinal System | U&I Corporation | 2013 | — |
| +1 | K160731 | LumFix Spinal Fixation Sytem | CG Bio Co., Ltd. | 2016 | — |
| +1 | K143417 | ANAX 5.5 Spinal System | U&I Corporation | 2015 | — |
| +1 | K162189 | ANAX™ 5.5 Spinal System | U&I Corporation | 2016 | — |
| +2 | K222229 | Advanced LumFix Spinal Fixation System | CG Bio Co., Ltd. | 2023 | — |
| +1 | K173524 | ANAX 5.5™ Spinal System | U&I Corporation | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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? (3)
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 |
|---|---|---|---|
| * | K011437 | Synergy 4.0 MM, 4.5 MM VLS ScrewsSummary page 2…rosis * Failed previous fusion Substantial Equivalence: The ANAXTM .5.5 Spinal System is substantially equivalent to SynergyT Spinal System - Synergy~m VLS Screws (K011437), Fixpine 11System TM (K100765) and QPTlItA'_ Spinal System (K024096) in design, material, mechanical performance, function and i… | 2001 |
| * | K100765 | Fixpine II SystemSummary page 1…system Product Code: MNH, MNI Predicate Devices: Synergy~m Spinal System - Synergy VLS Screws (1(011437) Fixpine ItSystem1TM (K1 00765) OPTIMAM Spinal System (K024096) Description of Device:… | 2010 |
| * | K024096 | Optima, Spinal SystemSummary page 1…es: Synergy~m Spinal System - Synergy VLS Screws (1(011437) Fixpine ItSystem1TM (K1 00765) OPTIMAM Spinal System (K024096) Description of Device: Tm The ANAXIm 5… | 2003 |
What descends from it? (13)
See all 137 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K160731 (CG Bio Co., Ltd., 2016) has gone furthest, with 6 descendants of its own.
- 11 other devices also cite its predicate K011437.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 ANAXTM 5.5 Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogerious bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
* Spondylolisthesis (Grade 3 and 4)
* Degenerative spondylolisthesis with objective evidence of neurological impairment
* Trauma (i.e., fracture or dislocation)
* Spinal stenosis
* Deformities or curvatures (iLe., scoliosis, kyphosis, and/or lordosis)
* Tumor
* Pseudoarthrosis
* Failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132101: Anax 5.5 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/K132101
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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