510(k) · Cleared
ClearedDiamond Rattlesnake System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eminent Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jun 26, 2014 as substantially equivalent to K922543 (Sofamor Danek Mfg., Inc., 1993) and 4 other predicates after a 252-day review. Its family tree reaches back 2 generations to 2006. 17 later devices descend from it.
- Decided
- Jun 26, 2014
- Review
- 252 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K061789 (2006). 7 ancestors in all, the oldest K922543 (1993). 17 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK061789 Lateral Plate SystemNuvasive, Inc. · 2006
- 1 generation backK091071 Nuvasive Lateral Plate SystemNuvasive, Inc. · 2009
- This deviceK133194 Diamond Rattlesnake SystemEminent Spine · 2014
- Descendant · cites it directly · 10 of its ownK172131 2 Hole Lateral Plating SystemLife Spine, Inc. · 2017
- Descendant · 2 generations on · 9 of its ownK180166 Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc. · 2018
- Descendant · 3 generations on · 5 of its ownK200338 ProLift Lateral FixatedLife Spine, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK162211 AccuFit Lateral Plate SystemPrecision Spine, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK220324 AccuFit Lateral 2-Hole PlatePrecision Spine, Inc. · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K1721312 Hole Lateral Plating SystemLife Spine, Inc. · 2017 · cites it directly10descendants
- K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc. · 2018 · 2 generations on9descendants
- K200338ProLift Lateral FixatedLife Spine, Inc. · 2020 · 3 generations on5descendants
- K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. · 2016 · cites it directly4descendants
- K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc. · 2022 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K061789 | Lateral Plate System | Nuvasive, Inc. | 2006 | — |
| −1 | K091071 | Nuvasive Lateral Plate System | Nuvasive, Inc. | 2009 | — |
| 0 (this device) | K133194 | Diamond Rattlesnake System | Eminent Spine | 2014 | — |
| +1 | K172131 | 2 Hole Lateral Plating System | Life Spine, Inc. | 2017 | — |
| +2 | K180166 | Life Spine Lumbar Fixation System (SENTRY) | Life Spine, Inc. | 2018 | — |
| +3 | K200338 | ProLift Lateral Fixated | Life Spine, Inc. | 2020 | — |
| +1 | K162211 | AccuFit Lateral Plate System | Precision Spine, Inc. | 2016 | — |
| +2 | K220324 | AccuFit Lateral 2-Hole Plate | Precision Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
Planning a device in KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K922543 | Z-Plate Anterior Fixation SystemSummary page 1…Spinal intervertebral body fixation orthosis Code -Classification KWQ 21 CFR 888.3060: Class 11 Predicate Devices Medtronic Z-Plate (K(922543) Acromed M-2 Plate (K(972718) Nuvasive Lateral Pl… | 1993 |
| * | K972718 | M-2 Anterior Plate SystemSummary page 1…fication KWQ 21 CFR 888.3060: Class 11 Predicate Devices Medtronic Z-Plate (K(922543) Acromed M-2 Plate (K(972718) Nuvasive Lateral Plate System (1(061789, 1(082070, 1(091071) Predicate Device - 2 H… | 1997 |
| * | K061789 | Lateral Plate SystemSummary page 1…edtronic Z-Plate (K(922543) Acromed M-2 Plate (K(972718) Nuvasive Lateral Plate System (1(061789, 1(082070, 1(091071) Predicate Device - 2 Hole uaieLtrlPteSsmK017 Ltrllt NuaieLateral… | 2006 |
| * | K082070 | Nuvasive Lateral Plate SystemSummary page 1…-Plate (K(922543) Acromed M-2 Plate (K(972718) Nuvasive Lateral Plate System (1(061789, 1(082070, 1(091071) Predicate Device - 2 Hole uaieLtrlPteSsmK017 Ltrllt NuaieLateral… | 2008 |
| * | K091071 | Nuvasive Lateral Plate SystemSummary page 1…922543) Acromed M-2 Plate (K(972718) Nuvasive Lateral Plate System (1(061789, 1(082070, 1(091071) Predicate Device - 2 Hole uaieLtrlPteSsmK017 Ltrllt NuaieLateral… | 2009 |
What descends from it? (17)
See all 173 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 8 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K172131 (Life Spine, Inc., 2017) has gone furthest, with 10 descendants of its own.
- 10 other devices also cite its predicate K922543.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The Eminent Spine Black Diamond Rattlesnake Lumbar Plating System is indicated for use via a lateral / anterolateral surgical approach above the great vessels in the treatment of the thoracolumbar spine (TI-Li). The Eminent Spine Red Diamond Rattlesnake Lumbar Plating System is indicated for use via an anterior surgical approach below the bifurcation of the great vessels in the treatment of the lumbosacral (LI-SI) spine. The Diamond Rattlesnake System is…
Read the full statement (145 words)
The Eminent Spine Black Diamond Rattlesnake Lumbar Plating System is indicated for use via a lateral / anterolateral surgical approach above the great vessels in the treatment of the thoracolumbar spine (TI-Li). The Eminent Spine Red Diamond Rattlesnake Lumbar Plating System is indicated for use via an anterior surgical approach below the bifurcation of the great vessels in the treatment of the lumbosacral (LI-SI) spine. The Diamond Rattlesnake System is intended to provide temporary stabilization as an adjunct to fusion using a lateral approach in skeletally mature patients for the treatment of the following acute and chronic instabilities and deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudarthrosis, spondylolysis, spondylolisthesis, deformity (scoliosis, kyphosis, and or lordosis). spinal stenosis, fracture (including dislocation and subluxation), tumor, or failed previous spine surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133194: Diamond Rattlesnake System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133194
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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