510(k) · Cleared
Recalled · Class II · 2017Maximis Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valorem Surgical · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jan 7, 2015 as substantially equivalent to K120538 (Korea Bone Bank Co., Ltd., 2012) after a 329-day review. Its family tree reaches back 7 generations to 2000. It has been recalled 144 times.
- Decided
- Jan 7, 2015
- Review
- 329 days
- Class
- Class II
- Product code
- MNH
- Recalls
- 144
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000319 (2000). 12 ancestors in all. No later device cites it as a predicate yet.
- 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 backK082509 Eos Spinal SystemKorea Bone Bank Co., Ltd. · 2008
- 2 generations backK102574 Palla M Spinal SystemKorea Bone Bank Co., Ltd. · 2011
- 1 generation backK120538 Palls M Spinal SystemKorea Bone Bank Co., Ltd. · 2012
- This deviceK140359 Maximis Spinal Fixation SystemValorem Surgical · 2015
View 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 | K082509 | Eos Spinal System | Korea Bone Bank Co., Ltd. | 2008 | — |
| −2 | K102574 | Palla M Spinal System | Korea Bone Bank Co., Ltd. | 2011 | — |
| −1 | K120538 | Palls M Spinal System | Korea Bone Bank Co., Ltd. | 2012 | — |
| 0 (this device) | K140359 | Maximis Spinal Fixation System | Valorem Surgical | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K120538 | Palls M Spinal SystemSummary page 5…used with autograft of allograft. 7. Comparison with predicate device: The MAXIMIS TM Spinal Fixation System is substantially equivalent to the Pallas M Spinal System (K120538), a currently marketed Spinal System. When considered for posterior applications, both the MAXIMIS TM Spinal Fixation System and… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 21, 2017 | Class II | Z-2879-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2875-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2936-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2978-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2998-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2926-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2944-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-3016-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2973-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2933-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-3002-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2951-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-3006-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2918-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2891-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2939-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2979-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2925-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2894-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2982-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2952-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2930-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2915-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2886-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-3005-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2941-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2956-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2962-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2999-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2901-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2893-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-3014-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2917-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2977-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2885-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2994-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2935-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-3015-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2928-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2959-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2971-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2989-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2889-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2987-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2995-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2927-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-3008-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2934-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2880-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
| Jun 21, 2017 | Class II | Z-2984-2017 | Device Design | Devices are not consistent with Quality System Requirements. |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 12 ancestors have a recall of any class.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Valorem Surgical MAXIMIS™ Pedicle Screw Fixation System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: 1) trauma (i.e. fracture or dislocation), 2) curvatures (scoliosis, kyphosis, and/or lordosis) 3) spinal tumor, 4) failed previous fusion, 5) pseudoarthrosis, 6) spinal stenosis. It is not intended for pedicle screw fixation above T8. This device may be used with autograft of allograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140359 · printed Nov 3, 2026
Cite this page
510(k) Report. “K140359: Maximis Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K140359
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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