510(k) · Cleared
ClearedZodiac Dynamo Semi-Rigid Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Oct 24, 2007 as substantially equivalent to K030383 (Depuyacromed, 2003) after an 86-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Oct 24, 2007
- Review
- 86 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K951116 (1995). 16 ancestors in all, the oldest K933881 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 3 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 2 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 1 generation backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- This deviceK072081 Zodiac Dynamo Semi-Rigid Spinal SystemAlphatec Spine, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK073143 Modified Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −3 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −2 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −1 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| 0 (this device) | K072081 | Zodiac Dynamo Semi-Rigid Spinal System | Alphatec Spine, Inc. | 2007 | — |
| +1 | K073143 | Modified Vertiflex Spinal Screw System | Vertiflex, Inc. | 2008 | — |
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 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 KWP? 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 |
|---|---|---|---|
| * | K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsSummary page 2…e devices: Trade/Proprietary Name Manufacturer Clearance Moss-Miami Spinal System DePuy Spine, Inc. K030383 Performance Data: Mechanical and dynamic testing of the semi-rigid spinal fixation system was performned. The test results demo… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073143 | Modified Vertiflex Spinal Screw System | 2008 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K073143 (Vertiflex, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 22 other devices also cite its predicate K030383.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only. 1) The Zodiac DynaMo Semi-Rigid Spinal System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for: a. Patients having fractures of the thoracic and lumbar spine. b. Patients having deformity (i.e.…
Read the full statement (256 words)
It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.
1) The Zodiac DynaMo Semi-Rigid Spinal System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine.
b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
2) The Zodiac DynaMo Semi-Rigid Spinal System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
3) In addition, the Zodiac DynaMo Semi-Rigid Spinal System, when used as a pedicle screw fixation system is intended for:
a. Patients receiving only autogenous bone graft.
b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4) The Zodiac DynaMo Semi-Rigid Spinal System, when used as a laminar hook and bone screw system is intended for:
a. Patients having fractures of thoracic and lumbar spine.
b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072081: Zodiac Dynamo Semi-Rigid Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072081
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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