510(k) · Cleared
ClearedCD Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofamor Danek USA,Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Dec 18, 1998 after a 332-day review. The FDA summary names no predicate by number. 68 later devices descend from it.
- Decided
- Dec 18, 1998
- Review
- 332 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
68 later devices descend from it, 1 citing it directly.
- This deviceK980184 CD Spinal SystemSofamor Danek USA,Inc. · 1998
- Descendant · cites it directly · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- Descendant · 2 generations on · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- Descendant · 3 generations on · 26 of its ownK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- Descendant · 4 generations on · 21 of its ownK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- Descendant · 2 generations on · 19 of its ownK150896 Vitality Spinal Fixation SystemZimmer Spine, Inc. · 2015 · Recalled
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · cites it directly67descendants
- K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · 2 generations on30descendants
- K150856Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · 3 generations on26descendants
- K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017 · 4 generations on21descendants
- K150896Vitality Spinal Fixation SystemZimmer Spine, Inc. · 2015 · 2 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980184 | CD Spinal System | Sofamor Danek USA,Inc. | 1998 | — |
| +1 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| +2 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | — |
| +3 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | — |
| +4 | K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | 2017 | — |
| +2 | K150896 | Vitality Spinal Fixation System | Zimmer Spine, Inc. | 2015 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 8 | 0 |
| 2026 | 8 | 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?
The FDA summary names no predicate by number.
What descends from it? (68)
See all 681 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133746 | Polaris Spinal System | 2014 | 67 |
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, K133746 (Biomet Spine (Aka Ebi, LLC), 2014) has gone furthest, with 67 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.
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?
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD™ Spinal System is indicated for one or more of the following: (1) degenerative disc disease (as defined by back pain.of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation…
Read the full statement (229 words)
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD™ Spinal System is indicated for one or more of the following: (1) degenerative disc disease (as defined by back pain.of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the CD ™ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fith lumbar-first sacral (L5-S1) vertebral joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed afier the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
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/K980184 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980184: CD Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980184
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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