510(k) · Cleared
ClearedMis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 4, 2010 as substantially equivalent to K081228 (Spine Wave, Inc., 2008) and 5 other predicates after a 93-day review. Its family tree reaches back 7 generations to 1995. 33 later devices descend from it.
- Decided
- Jun 4, 2010
- Review
- 93 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K951116 (1995). 30 ancestors in all, the oldest K933881 (1994). 33 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 6 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 5 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 4 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- 3 generations backK070245 Capsure Pedicle Screw SystemSpine Wave, Inc. · 2007
- 2 generations backK081228 Capsure PS (R) Spine SystemSpine Wave, Inc. · 2008
- 1 generation backK083353 Capsure (R) PS SystemSpine Wave, Inc. · 2008
- This deviceK100605 Mis SystemSpine Wave, Inc. · 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 · cites it directly · 9 of its ownK151813 Sniper Spine SystemSpine Wave, Inc. · 2015
- Descendant · 2 generations on · 8 of its ownK152174 Sniper Spine SystemSpine Wave, Inc. · 2015
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · 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
- K151813Sniper Spine SystemSpine Wave, Inc. · 2015 · cites it directly9descendants
- K152174Sniper Spine SystemSpine Wave, Inc. · 2015 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −6 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −5 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −4 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| −3 | K070245 | Capsure Pedicle Screw System | Spine Wave, Inc. | 2007 | — |
| −2 | K081228 | Capsure PS (R) Spine System | Spine Wave, Inc. | 2008 | — |
| −1 | K083353 | Capsure (R) PS System | Spine Wave, Inc. | 2008 | — |
| 0 (this device) | K100605 | Mis System | Spine Wave, Inc. | 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 | — |
| +1 | K151813 | Sniper Spine System | Spine Wave, Inc. | 2015 | — |
| +2 | K152174 | Sniper Spine System | Spine Wave, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K081228 | Capsure PS (R) Spine SystemSummary page 2…o be removed after solid fusion is attained. 5. Substantial equivalence The MIS Pedicle Screw System is substantially equivalent to the CapSure® PS Spine System (K08 1228 and K083353), the DePuy Spine VIPER System (K06 1520 and K07 1860) and the Medtronic CD Horizon System for use with Sextant… | 2008 |
| * | K083353 | Capsure (R) PS SystemSummary page 2…after solid fusion is attained. 5. Substantial equivalence The MIS Pedicle Screw System is substantially equivalent to the CapSure® PS Spine System (K08 1228 and K083353), the DePuy Spine VIPER System (K06 1520 and K07 1860) and the Medtronic CD Horizon System for use with Sextant Instrumenta… | 2008 |
| * | K061520 | Viper Spine SystemSummary page 2…tial equivalence The MIS Pedicle Screw System is substantially equivalent to the CapSure® PS Spine System (K08 1228 and K083353), the DePuy Spine VIPER System (K06 1520 and K07 1860) and the Medtronic CD Horizon System for use with Sextant Instrumentation (K032033 and K032265). The MIS Pedi… | 2006 |
| * | K071860 | Modification to: Viper Spine SystemSummary page 2…nce The MIS Pedicle Screw System is substantially equivalent to the CapSure® PS Spine System (K08 1228 and K083353), the DePuy Spine VIPER System (K06 1520 and K07 1860) and the Medtronic CD Horizon System for use with Sextant Instrumentation (K032033 and K032265). The MIS Pedicle System is… | 2007 |
| * | K032033 | CD Horizon Spinal SystemSummary page 2…Spine System (K08 1228 and K083353), the DePuy Spine VIPER System (K06 1520 and K07 1860) and the Medtronic CD Horizon System for use with Sextant Instrumentation (K032033 and K032265). The MIS Pedicle System is substantially equivalent in intended use, design, materials, and construction to t… | 2003 |
| * | K032265 | CD Horizon Spinal SystemSummary page 2…(K08 1228 and K083353), the DePuy Spine VIPER System (K06 1520 and K07 1860) and the Medtronic CD Horizon System for use with Sextant Instrumentation (K032033 and K032265). The MIS Pedicle System is substantially equivalent in intended use, design, materials, and construction to the predicate… | 2003 |
What descends from it? (33)
See all 334 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 15 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 30 ancestors have a recall of any class.
- Of its descendants, K111115 (Captiva Spine, Inc., 2011) has gone furthest, with 16 descendants of its own.
- 4 other devices also cite its predicate K081228.
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?
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MIS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The MIS Pedicle Screw System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis…
Read the full statement (240 words)
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MIS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The MIS Pedicle Screw System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L-5-S I vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S 1), and for whom the device is intended to be removed after solid fusion is attained.
The Spine Wave MIS Percutaneous Instruments are intended to be used with the MIS Pedicle Screw System [mplants. The percutaneous instruments when used with the percutaneous cannulated screws and percutaneous rods, are intended to provide the surgeon with a percutaneous approach for posterior spinal surgery for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). As well as, for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-SlI vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S 1), and for whom the device is intended to be removed after solid fusion is attained.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100605: Mis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100605
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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