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 Aug 30, 2016 as substantially equivalent to K132101 (U&I Corporation, 2013) and 1 other predicate after a 26-day review. Its family tree reaches back 7 generations to 2000. 3 later devices descend from it.
- Decided
- Aug 30, 2016
- Review
- 26 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K000319 (2000). 14 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 6 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 5 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 4 generations backK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- 3 generations backK100765 Fixpine II SystemDio Medical Co., Ltd. · 2010
- 2 generations backK132101 Anax 5.5 Spinal SystemU&I Corporation · 2013
- 1 generation backK143417 ANAX 5.5 Spinal SystemU&I Corporation · 2015
- This deviceK162189 ANAX™ 5.5 Spinal SystemU&I Corporation · 2016
- Descendant · cites it directly · 2 of its ownK173524 ANAX 5.5™ Spinal SystemU&I Corporation · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK231737 ANAX™ 5.5 Spinal SystemInnosys Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK233960 INNOVERSE Spinal SystemInnosys Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −6 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −5 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −4 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| −3 | K100765 | Fixpine II System | Dio Medical Co., Ltd. | 2010 | — |
| −2 | K132101 | Anax 5.5 Spinal System | U&I Corporation | 2013 | — |
| −1 | K143417 | ANAX 5.5 Spinal System | U&I Corporation | 2015 | — |
| 0 (this device) | K162189 | ANAX™ 5.5 Spinal System | U&I Corporation | 2016 | — |
| +1 | K173524 | ANAX 5.5™ Spinal System | U&I Corporation | 2017 | 1 |
| +1 | K231737 | ANAX™ 5.5 Spinal System | Innosys Co., Ltd. | 2023 | — |
| +1 | K233960 | INNOVERSE Spinal System | Innosys Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K132101 | Anax 5.5 Spinal SystemSummary page 4…FR 888.3070 Common Name: Pedicle screw spinal fixation system Product Code: MNH, MNI (Class II) Primary Predicate: ANAXTM 5.5 Spinal System (K132101) Additional Predicate: ANAXTM 5.5 Spinal System (K143417) Description of Device: The ANAXTM 5.5 Spinal System is manufacture… | 2013 |
| * | K143417 | ANAX 5.5 Spinal SystemSummary page 4…l fixation system Product Code: MNH, MNI (Class II) Primary Predicate: ANAXTM 5.5 Spinal System (K132101) Additional Predicate: ANAXTM 5.5 Spinal System (K143417) Description of Device: The ANAXTM 5.5 Spinal System is manufactured by U&I corporation. The ANAXTM 5.5 Spinal System is a t… | 2015 |
What descends from it? (3)
3 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 16 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K173524 (U&I Corporation, 2017) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K132101.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 ANAX™ 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 autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
Spondylolithesis (Grade 3 and 4)
Degenerative spondylolisthesis with objective evidence of neurological impairment
Trauma (i.e., fracture or dislocation)
Spinal stenosis
Defomities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
Tumor
Pseudoarthrosis
Failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162189: 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/K162189
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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