510(k) · Cleared
ClearedSniper (R) Spine 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 Feb 26, 2016 as substantially equivalent to K152174 (Spine Wave, Inc., 2015) and 1 other predicate after a 53-day review. Its family tree reaches back 10 generations to 1995. 7 later devices descend from it.
- Decided
- Feb 26, 2016
- Review
- 53 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K951116 (1995). 35 ancestors in all, the oldest K933881 (1994). 7 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 6 generations between
- 3 generations backK100605 Mis SystemSpine Wave, Inc. · 2010
- 2 generations backK151813 Sniper Spine SystemSpine Wave, Inc. · 2015
- 1 generation backK152174 Sniper Spine SystemSpine Wave, Inc. · 2015
- This deviceK160003 Sniper (R) Spine SystemSpine Wave, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK182954 Salvo™ Spine SystemSpine Wave, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK191045 Salvo™ Spine SystemSpine Wave, Inc. · 2019
- Descendant · 3 generations on · 4 of its ownK202476 Salvo® Spine SystemSpine Wave, Inc. · 2020
- Descendant · 4 generations on · 3 of its ownK222362 Salvo® Spine SystemSpine Wave, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK240685 Salvo® Spine SystemSpine Wave, Inc. · 2024
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 backK100605 Mis SystemSpine Wave, Inc. · 2010
- 2 generations backK151813 Sniper Spine SystemSpine Wave, Inc. · 2015
- 1 generation backK152174 Sniper Spine SystemSpine Wave, Inc. · 2015
- This deviceK160003 Sniper (R) Spine SystemSpine Wave, Inc. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K182954Salvo™ Spine SystemSpine Wave, Inc. · 2018 · cites it directly6descendants
- K191045Salvo™ Spine SystemSpine Wave, Inc. · 2019 · 2 generations on5descendants
- K202476Salvo® Spine SystemSpine Wave, Inc. · 2020 · 3 generations on4descendants
- K222362Salvo® Spine SystemSpine Wave, Inc. · 2022 · 4 generations on3descendants
- K240685Salvo® Spine SystemSpine Wave, Inc. · 2024 · cites it directly2descendants
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 | K100605 | Mis System | Spine Wave, Inc. | 2010 | — |
| −2 | K151813 | Sniper Spine System | Spine Wave, Inc. | 2015 | — |
| −1 | K152174 | Sniper Spine System | Spine Wave, Inc. | 2015 | — |
| 0 (this device) | K160003 | Sniper (R) Spine System | Spine Wave, Inc. | 2016 | — |
| +1 | K182954 | Salvo™ Spine System | Spine Wave, Inc. | 2018 | — |
| +2 | K191045 | Salvo™ Spine System | Spine Wave, Inc. | 2019 | — |
| +3 | K202476 | Salvo® Spine System | Spine Wave, Inc. | 2020 | — |
| +4 | K222362 | Salvo® Spine System | Spine Wave, Inc. | 2022 | — |
| +1 | K240685 | Salvo® Spine System | Spine Wave, Inc. | 2024 | — |
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 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K152174 | Sniper Spine SystemSummary page 5…cates: Predicate Device Manufacturer 510(k) No. Primary Predicate Sniper® Spine System Spine Wave, Inc. K152174 Additional Predicate CapSure® PS System Spine Wave, Inc. K132154 5. Device Description The Sniper® Spine… | 2015 |
| * | K132154 | Capsure PS SystemSummary page 5…10(k) No. Primary Predicate Sniper® Spine System Spine Wave, Inc. K152174 Additional Predicate CapSure® PS System Spine Wave, Inc. K132154 5. Device Description The Sniper® Spine System consists of a selection of non-sterile, single use, titanium alloy screw a… | 2013 |
What descends from it? (7)
2 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 21 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 35 ancestors have a recall of any class.
- Of its descendants, K182954 (Spine Wave, Inc., 2018) has gone furthest, with 6 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. 2016, 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 Sniper® Spine System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) in skeletally mature patients. The Sniper® Spine System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The Sniper® Spine System is also indicated for pedicle screw fixation in…
Read the full statement (246 words)
The Sniper® Spine System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) in skeletally mature patients. The Sniper® Spine System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Sniper® Spine 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.
The Sniper® Spine System percutaneous instruments are intended to be used with the Sniper® System Implants. The 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). The instruments are also intended to provide a percutaneous approach 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 L.3-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/K160003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160003: Sniper (R) Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160003
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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