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. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Oct 16, 1997 after a 365-day review. The FDA summary names no predicate by number. 281 later devices descend from it.
- Decided
- Oct 16, 1997
- Review
- 365 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
281 later devices descend from it, 4 citing it directly.
- This deviceK964159 CD Spinal SystemSofamor Danek USA,Inc. · 1997
- Descendant · cites it directly · 251 of its ownK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- Descendant · 2 generations on · 250 of its ownK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- Descendant · 3 generations on · 131 of its ownK061162 Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc. · 2006
- Descendant · 4 generations on · 130 of its ownK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
- Descendant · 5 generations on · 117 of its ownK100044 Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010
Showing 5 of 281 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 281 · See all- K980484Aesculap Spine System EvolutionAesculap, Inc. · 1998 · cites it directly251descendants
- K990118Isobar Spinal SystemScien'Tx USA, Inc. · 1999 · 2 generations on250descendants
- K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc. · 2006 · 3 generations on131descendants
- K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · 4 generations on130descendants
- K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010 · 5 generations on117descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964159 | CD Spinal System | Sofamor Danek USA,Inc. | 1997 | — |
| +1 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| +2 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| +3 | K061162 | Bar Pedicle Screw Spinal Fixation System, Model 2020 | Applied Spine Technologies, Inc. | 2006 | — |
| +4 | K092624 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2009 | 1 |
| +5 | K100044 | Firebird Spinal Fixation System, Firebird Side-Loading Body | Blackstone | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 14 | 0 |
| 2016 | 14 | 0 |
| 2017 | 20 | 0 |
| 2018 | 15 | 0 |
| 2019 | 16 | 0 |
| 2020 | 20 | 0 |
| 2021 | 16 | 0 |
| 2022 | 17 | 0 |
| 2023 | 23 | 0 |
| 2024 | 28 | 0 |
| 2025 | 26 | 0 |
| 2026 | 18 | 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?
The FDA summary names no predicate by number.
What descends from it? (281)
See all 2814 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?
- Of its descendants, K980484 (Aesculap, Inc., 1998) has gone furthest, with 251 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
When used as a pedicle screw fixation system with CD screws attached to the non-cervical posterior spine, the CD Spinal System is indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). When used as a pedicle screw fixation system, the CD Spinal System is also indicated for Grade III and IV spondylolisthesis. For this indication only, the…
Read the full statement (200 words)
When used as a pedicle screw fixation system with CD screws attached to the non-cervical posterior spine, the CD Spinal System is indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
When used as a pedicle screw fixation system, the CD Spinal System is also indicated for Grade III and IV spondylolisthesis. For this indication only, the spondylolisthesis must be at L5-S1 in patients who are receiving fusions using autogenous bone graft only and who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint for these severe spondylolisthesis cases, the levels of pedicle screw fixation may be L3 to the sacrum.
When used as a posterior non-pedicle screw fixation system, the CD Spinal System is intended for the indications given above as well as spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), fracture, pseudarthrosis, tumor resection, and unsuccessful previous attempts at spinal fusion. For non-pedicle screw use, the levels of fixation for the CD Spinal System are T1 to sacrum, with the screws limited to sacral fixation.
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/K964159 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964159: 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/K964159
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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