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 Oct 11, 2012 after a 77-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 12 later devices descend from it.
- Decided
- Oct 11, 2012
- Review
- 77 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
12 later devices descend from it, 1 citing it directly.
- This deviceK122233 Capsure (R) PS SystemSpine Wave, Inc. · 2012
- Descendant · cites it directly · 11 of its ownK132154 Capsure PS SystemSpine Wave, Inc. · 2013
- Descendant · 2 generations on · 7 of its ownK160003 Sniper (R) Spine SystemSpine Wave, Inc. · 2016
- Descendant · 3 generations on · 6 of its ownK182954 Salvo™ Spine SystemSpine Wave, Inc. · 2018
- Descendant · 4 generations on · 5 of its ownK191045 Salvo™ Spine SystemSpine Wave, Inc. · 2019
- Descendant · 5 generations on · 4 of its ownK202476 Salvo® Spine SystemSpine Wave, Inc. · 2020
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K132154Capsure PS SystemSpine Wave, Inc. · 2013 · cites it directly11descendants
- K160003Sniper (R) Spine SystemSpine Wave, Inc. · 2016 · 2 generations on7descendants
- K182954Salvo™ Spine SystemSpine Wave, Inc. · 2018 · 3 generations on6descendants
- K191045Salvo™ Spine SystemSpine Wave, Inc. · 2019 · 4 generations on5descendants
- K202476Salvo® Spine SystemSpine Wave, Inc. · 2020 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122233 | Capsure (R) PS System | Spine Wave, Inc. | 2012 | — |
| +1 | K132154 | Capsure PS System | Spine Wave, Inc. | 2013 | — |
| +2 | K160003 | Sniper (R) Spine System | Spine Wave, Inc. | 2016 | — |
| +3 | K182954 | Salvo™ Spine System | Spine Wave, Inc. | 2018 | — |
| +4 | K191045 | Salvo™ Spine System | Spine Wave, Inc. | 2019 | — |
| +5 | K202476 | Salvo® Spine System | Spine Wave, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K104 | CapSure® PS System Number could not be read Summary page 1…redicate: Predicate Device Manufacturer 510(k) No. CapSure® PS System Spine Wave, Inc. LK104 5. Device Description The predicate CapSure®'PS System consists of a selection of non-sterile, single use, titanium alloy… |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132154 | Capsure PS System | 2013 | 11 |
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?
- Of its descendants, K132154 (Spine Wave, Inc., 2013) has gone furthest, with 11 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. 2012, 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 as stated in the FDA summary.
https://510kreport.com/device/K122233 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122233: Capsure (R) PS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122233
Report an extraction error
Are you the manufacturer?
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