510(k) · Cleared
ClearedCotrel-Dubousset (CD) Spinal
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 1, 1996 after a 284-day review. The FDA summary names no predicate by number. 15 later devices descend from it.
- Decided
- Oct 1, 1996
- Review
- 284 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK955807 Cotrel-Dubousset (CD) SpinalSofamor Danek USA,Inc. · 1996
- Descendant · cites it directly · 14 of its ownK031595 U & I America Spinal Hook SystemU&I Corp., America · 2003 · Recalled
- Descendant · 2 generations on · 6 of its ownK113324 Rexious Hook Fixation SystemsDio Medical Co., Ltd. · 2012
- Descendant · 2 generations on · 5 of its ownK123476 Mega 5.5 Spine SystemLsk Biopartners, Inc. · 2013
- Descendant · 3 generations on · 4 of its ownK171497 Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
- Descendant · 4 generations on · 3 of its ownK241657 MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K031595U & I America Spinal Hook SystemU&I Corp., America · 2003 · cites it directly14descendants
- K113324Rexious Hook Fixation SystemsDio Medical Co., Ltd. · 2012 · 2 generations on6descendants
- K123476Mega 5.5 Spine SystemLsk Biopartners, Inc. · 2013 · 2 generations on5descendants
- K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017 · 3 generations on4descendants
- K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955807 | Cotrel-Dubousset (CD) Spinal | Sofamor Danek USA,Inc. | 1996 | — |
| +1 | K031595 | U & I America Spinal Hook System | U&I Corp., America | 2003 | 3 |
| +2 | K113324 | Rexious Hook Fixation Systems | Dio Medical Co., Ltd. | 2012 | — |
| +2 | K123476 | Mega 5.5 Spine System | Lsk Biopartners, Inc. | 2013 | — |
| +3 | K171497 | Mikron Spinal Fixation System | Mikron Makina Sanayi Ticaret Co., Ltd. | 2017 | — |
| +4 | K241657 | MSFX Mikron Spinal Fixation System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 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? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031595 | U & I America Spinal Hook System | 2003 | 14 |
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, K031595 (U&I Corp., America, 2003) has gone furthest, with 14 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?
The CD™ Spinal System is limited to non-cervical use in the posterior spine. The CD spinal screws, when used as pedicle screws with the CD™ Spinal System, are intended only for patients: (a) having severe spondylolisthesis (grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are…
Read the full statement (236 words)
The CD™ Spinal System is limited to non-cervical use in the posterior spine. The CD spinal screws, when used as pedicle screws with the CD™ Spinal System, are intended only for patients: (a) having severe spondylolisthesis (grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Otherwise, the CD screws, when used in posterior fixation, are intended for sacral/iliac attachment only. Except for situations where stainless steel screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a CD construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the CD Spinal System (either stainless steel or titanium alloy versions) are the following:
1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by radiographic studies).
2. Pseudoarthrosis
Unsuccessful previous attempts at spinal fusion
Tumor resection
3. Stenosis
4. Spondylolisthesis
5. Spinal deformities: scoliosis, kyphosis, and lordosis
6. Fracture
All of the CD hooks are intended for posterior thoracic and/or lumbar use only. CD cross connectors are intended for posterior thoracic, lumbar, and/or sacral use only.
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/K955807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955807: Cotrel-Dubousset (CD) Spinal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955807
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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