510(k) · Cleared
ClearedCapsure (R) PS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Dec 11, 2008 as substantially equivalent to K081228 (Spine Wave, Inc., 2008) after a 28-day review. Its family tree reaches back 6 generations to 1995. 36 later devices descend from it.
- Decided
- Dec 11, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K951116 (1995). 23 ancestors in all, the oldest K933881 (1994). 36 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 5 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 4 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 3 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- 2 generations backK070245 Capsure Pedicle Screw SystemSpine Wave, Inc. · 2007
- 1 generation backK081228 Capsure PS (R) Spine SystemSpine Wave, Inc. · 2008
- This deviceK083353 Capsure (R) PS SystemSpine Wave, Inc. · 2008
- Descendant · cites it directly · 33 of its ownK100605 Mis SystemSpine Wave, Inc. · 2010
- Descendant · 2 generations on · 16 of its ownK111115 Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc. · 2011
- Descendant · 3 generations on · 15 of its ownK120292 Caplox II Pedicle Screw SystemCaptiva Spine, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 14 of its ownK122332 Towerlox Pedicle Screw SystemCaptiva Spine · 2012
- Descendant · 2 generations on · 9 of its ownK151813 Sniper Spine SystemSpine Wave, Inc. · 2015
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K100605Mis SystemSpine Wave, Inc. · 2010 · cites it directly33descendants
- K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc. · 2011 · 2 generations on16descendants
- K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc. · 2012 · 3 generations on15descendants
- K122332Towerlox Pedicle Screw SystemCaptiva Spine · 2012 · 3 generations on14descendants
- K151813Sniper Spine SystemSpine Wave, Inc. · 2015 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −5 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −4 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −3 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| −2 | K070245 | Capsure Pedicle Screw System | Spine Wave, Inc. | 2007 | — |
| −1 | K081228 | Capsure PS (R) Spine System | Spine Wave, Inc. | 2008 | — |
| 0 (this device) | K083353 | Capsure (R) PS System | Spine Wave, Inc. | 2008 | — |
| +1 | K100605 | Mis System | Spine Wave, Inc. | 2010 | — |
| +2 | K111115 | Captiva Spine Caplox II Spinal Fixation System | Captiva Spine, Inc. | 2011 | — |
| +3 | K120292 | Caplox II Pedicle Screw System | Captiva Spine, Inc. | 2012 | 1 |
| +3 | K122332 | Towerlox Pedicle Screw System | Captiva Spine | 2012 | — |
| +2 | K151813 | 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 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 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 MNI? 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 |
|---|---|---|---|
| * | K081228 | Capsure PS (R) Spine SystemSummary page 2…vice: Predicate Device IManufacturer 510(k) No. CapSure" PS System Spine Wave, Inc. K081228 In addition, mechanical testing demonstrated that the CapSure ® PS System is equivalent to its predicate device. The m… | 2008 |
What descends from it? (36)
See all 365 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 4 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K100605 (Spine Wave, Inc., 2010) has gone furthest, with 33 descendants of its own.
- 4 other devices also cite its predicate K081228.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 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 CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis…
Read the full statement (109 words)
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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-S1), 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/K083353 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083353: Capsure (R) PS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083353
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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