510(k) · Cleared
ClearedSpondy Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allure Spine LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jul 9, 2010 as substantially equivalent to K091725 (U&I Corp., 2009) and 4 other predicates after a 93-day review. Its family tree reaches back 4 generations to 2000. 17 later devices descend from it.
- Decided
- Jul 9, 2010
- Review
- 93 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K000319 (2000). 18 ancestors in all, the oldest K901587 (1990). 17 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 3 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 2 generations backK024096 Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 1 generation backK091725 Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020…U&I Corp. · 2009
- This deviceK100956 Spondy Spinal Fixation SystemAllure Spine LLC · 2010
- Descendant · cites it directly · 16 of its ownK111115 Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc. · 2011
- Descendant · 2 generations on · 15 of its ownK120292 Caplox II Pedicle Screw SystemCaptiva Spine, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 14 of its ownK122332 Towerlox Pedicle Screw SystemCaptiva Spine · 2012
- Descendant · 3 generations on · 6 of its ownK131538 Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013
- Descendant · 3 generations on · 5 of its ownK152781 Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc. · 2011 · cites it directly16descendants
- K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc. · 2012 · 2 generations on15descendants
- K122332Towerlox Pedicle Screw SystemCaptiva Spine · 2012 · 2 generations on14descendants
- K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013 · 3 generations on6descendants
- K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2016 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −3 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −2 | K024096 | Optima, Spinal System | U&I Corp., America | 2003 | 3 |
| −1 | K091725 | Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549) | U&I Corp. | 2009 | — |
| 0 (this device) | K100956 | Spondy Spinal Fixation System | Allure Spine LLC | 2010 | — |
| +1 | K111115 | Captiva Spine Caplox II Spinal Fixation System | Captiva Spine, Inc. | 2011 | — |
| +2 | K120292 | Caplox II Pedicle Screw System | Captiva Spine, Inc. | 2012 | 1 |
| +2 | K122332 | Towerlox Pedicle Screw System | Captiva Spine | 2012 | — |
| +3 | K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw System | Captiva Spine | 2013 | — |
| +3 | K152781 | Adena-Zina System | Shanghai Sanyou Medical Co, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K091725 | Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549)Summary page 2…tion is included. The Spondy Spinal Fixation System is substantially equivalent to the predicate devices: PerfiXTM Spinal System (K091725), The OPTIMA TM Spinal System (K024096), the HydraLok TM (KO51216), and the Synergy VLS (K950099,… | 2009 |
| * | K024096 | Optima, Spinal SystemSummary page 2…ation System is substantially equivalent to the predicate devices: PerfiXTM Spinal System (K091725), The OPTIMA TM Spinal System (K024096), the HydraLok TM (KO51216), and the Synergy VLS (K950099, K041449). Performance Data:… | 2003 |
| * | K051216 | Hydralok System | 2005 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 2…devices: PerfiXTM Spinal System (K091725), The OPTIMA TM Spinal System (K024096), the HydraLok TM (KO51216), and the Synergy VLS (K950099, K041449). Performance Data: Performance data was submitted to characterize the… | 1997 |
| * | K041449 | Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction SeatSummary page 2…rfiXTM Spinal System (K091725), The OPTIMA TM Spinal System (K024096), the HydraLok TM (KO51216), and the Synergy VLS (K950099, K041449). Performance Data: Performance data was submitted to characterize the Spondy Spinal… | 2004 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111115 | Captiva Spine Caplox II Spinal Fixation System | 2011 | 16 |
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 10 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K111115 (Captiva Spine, Inc., 2011) has gone furthest, with 16 descendants of its own.
- 3 other devices also cite its predicate K091725.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Spond y TM Spinal Fixation System is a posterior, non-cervical pedlicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation…
Read the full statement (148 words)
The Spond y TM Spinal Fixation System is a posterior, non-cervical pedlicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, when used as a pedlicle screw fixation system, the Spondy Spinal Fixation System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100956 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100956: Spondy Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100956
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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