510(k) · Cleared
ClearedCapsure 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 Aug 9, 2013 as substantially equivalent to K122233 (Spine Wave, Inc., 2012) after a 28-day review. Its family tree reaches back 1 generation to 2012. 11 later devices descend from it.
- Decided
- Aug 9, 2013
- Review
- 28 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K122233 (2012). 11 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK122233 Capsure (R) PS SystemSpine Wave, Inc. · 2012
- This deviceK132154 Capsure PS SystemSpine Wave, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK160003 Sniper (R) Spine SystemSpine Wave, Inc. · 2016
- Descendant · 2 generations on · 6 of its ownK182954 Salvo™ Spine SystemSpine Wave, Inc. · 2018
- Descendant · 3 generations on · 5 of its ownK191045 Salvo™ Spine SystemSpine Wave, Inc. · 2019
- Descendant · 4 generations on · 4 of its ownK202476 Salvo® Spine SystemSpine Wave, Inc. · 2020
- Descendant · 5 generations on · 3 of its ownK222362 Salvo® Spine SystemSpine Wave, Inc. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K160003Sniper (R) Spine SystemSpine Wave, Inc. · 2016 · cites it directly7descendants
- K182954Salvo™ Spine SystemSpine Wave, Inc. · 2018 · 2 generations on6descendants
- K191045Salvo™ Spine SystemSpine Wave, Inc. · 2019 · 3 generations on5descendants
- K202476Salvo® Spine SystemSpine Wave, Inc. · 2020 · 4 generations on4descendants
- K222362Salvo® Spine SystemSpine Wave, Inc. · 2022 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K122233 | Capsure (R) PS System | Spine Wave, Inc. | 2012 | — |
| 0 (this device) | K132154 | Capsure PS System | Spine Wave, Inc. | 2013 | — |
| +1 | K160003 | Sniper (R) Spine System | Spine Wave, Inc. | 2016 | — |
| +2 | K182954 | Salvo™ Spine System | Spine Wave, Inc. | 2018 | — |
| +3 | K191045 | Salvo™ Spine System | Spine Wave, Inc. | 2019 | — |
| +4 | K202476 | Salvo® Spine System | Spine Wave, Inc. | 2020 | — |
| +5 | K222362 | Salvo® Spine System | Spine Wave, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K122233 | Capsure (R) PS SystemSummary page 4…System described in this submission is substantially equivalent to the following predicate: Predicate Device Manufacturer 510(k) No. CapSure® PS System Spine Wave, Inc. K122233 . Device Description The predicate CapSure® PS System consists of a selection of non-sterile, single use, titanium alloy screws… | 2012 |
What descends from it? (11)
See all 113 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?
- Its one ancestor has no recall.
- Of its descendants, K160003 (Spine Wave, Inc., 2016) has gone furthest, with 7 descendants of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The CapSure® PS System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) 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…
Read the full statement (114 words)
The CapSure® PS System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) 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-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K132154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132154: Capsure PS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132154
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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