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 Jun 7, 2012 as substantially equivalent to K070245 (Spine Wave, Inc., 2007) and 7 other predicates after a 97-day review. Its family tree reaches back 10 generations to 1995. 1 of the 83 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 7, 2012
- Review
- 97 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 10 generations to K951116 (1995). 82 ancestors in all, the oldest K926453 (1993). No later device cites it as a predicate yet. 1 of the 83 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 6 generations between
- 3 generations backK083743 Capsure PS SystemSpine Wave, Inc. · 2009
- 2 generations backK100122 Modification to Capsure PS SystemSpine Wave, Inc. · 2010
- 1 generation backK111913 Capsure (R) PS SystemSpine Wave, Inc. · 2011
- This deviceK120646 Capsure (R) PS SystemSpine Wave, Inc. · 2012
Show all 10 generations
- Root · 10 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 9 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 8 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 7 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- 6 generations backK070245 Capsure Pedicle Screw SystemSpine Wave, Inc. · 2007
- 5 generations backK081228 Capsure PS (R) Spine SystemSpine Wave, Inc. · 2008
- 4 generations backK083353 Capsure (R) PS SystemSpine Wave, Inc. · 2008
- 3 generations backK083743 Capsure PS SystemSpine Wave, Inc. · 2009
- 2 generations backK100122 Modification to Capsure PS SystemSpine Wave, Inc. · 2010
- 1 generation backK111913 Capsure (R) PS SystemSpine Wave, Inc. · 2011
- This deviceK120646 Capsure (R) PS SystemSpine Wave, Inc. · 2012
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −9 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −8 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −7 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| −6 | K070245 | Capsure Pedicle Screw System | Spine Wave, Inc. | 2007 | — |
| −5 | K081228 | Capsure PS (R) Spine System | Spine Wave, Inc. | 2008 | — |
| −4 | K083353 | Capsure (R) PS System | Spine Wave, Inc. | 2008 | — |
| −3 | K083743 | Capsure PS System | Spine Wave, Inc. | 2009 | — |
| −2 | K100122 | Modification to Capsure PS System | Spine Wave, Inc. | 2010 | — |
| −1 | K111913 | Capsure (R) PS System | Spine Wave, Inc. | 2011 | — |
| 0 (this device) | K120646 | Capsure (R) PS System | Spine Wave, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 1 |
| 2011 | 2 | 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.
1 device in this family has a Class I recall. 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? (8)
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 |
|---|---|---|---|
| * | K070245 | Capsure Pedicle Screw SystemSummary page 1…following predicates: Predicate Device Manufacturer 510(k) No. CapSure® PS System Spine Wave, Inc. K070245, K081228, K083353, K083743,… | 2007 |
| * | K081228 | Capsure PS (R) Spine SystemSummary page 1…lowing predicates: Predicate Device Manufacturer 510(k) No. CapSure® PS System Spine Wave, Inc. K070245, K081228, K083353, K083743,… | 2008 |
| * | K083353 | Capsure (R) PS SystemSummary page 1…510(k) No. CapSure® PS System Spine Wave, Inc. K070245, K081228, K083353, K083743, K100122, and KI 11913 XIA® 3 System… | 2008 |
| * | K083743 | Capsure PS SystemSummary page 1…510(k) No. CapSure® PS System Spine Wave, Inc. K070245, K081228, K083353, K083743, K100122, and KI 11913 XIA® 3 System Stryke… | 2009 |
| * | K100122 | Modification to Capsure PS SystemSummary page 1…K070245, K081228, K083353, K083743, K100122, and KI 11913 XIA® 3 System Stryker Spine K083393 USS System Synthes… | 2010 |
| * | K111913 | Capsure (R) PS System | 2011 |
| * | K083393 | Xia 3 Spinal SystemSummary page 1…K083353, K083743, K100122, and KI 11913 XIA® 3 System Stryker Spine K083393 USS System Synthes K111358 5. Device Description The CapSure®@… | 2009 |
| * | K111358 | Synthes UssSummary page 1…K100122, and KI 11913 XIA® 3 System Stryker Spine K083393 USS System Synthes K111358 5. Device Description The CapSure®@ PS System consists of a selection of non-sterile, single use, titanium al… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 12 of the 82 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K070245.
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/K120646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120646: Capsure (R) 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/K120646
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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