510(k) · Cleared
ClearedSpinal Concepts, Inc., Cfix Cable System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Concepts, Inc. · JDQ Cerclage, Fixation
Cleared on Dec 19, 1997 as substantially equivalent to K925812 (Sofamor Danek Mfg., Inc., 1993) after a 58-day review. Its family tree reaches back 1 generation to 1993. 49 later devices descend from it.
- Decided
- Dec 19, 1997
- Review
- 58 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925812 (1993). 49 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- This deviceK974020 Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997
- Descendant · cites it directly · 48 of its ownK060009 Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006
- Descendant · 2 generations on · 46 of its ownK081622 Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
- Descendant · 3 generations on · 45 of its ownK091190 Universal Clamp Stainless Steel System, Models SNA027-0-30060…Zimmer Spine, Inc. · 2009
- Descendant · 2 generations on · 44 of its ownK110348 Universal Clamp Spinal Fixation SystemZimmer Spine · 2011
- Descendant · 2 generations on · 27 of its ownK121541 Jazz SystemImplanet, S.A. · 2012
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K060009Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006 · cites it directly48descendants
- K081622Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008 · 2 generations on46descendants
- K091190Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063Zimmer Spine, Inc. · 2009 · 3 generations on45descendants
- K110348Universal Clamp Spinal Fixation SystemZimmer Spine · 2011 · 2 generations on44descendants
- K121541Jazz SystemImplanet, S.A. · 2012 · 2 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925812 | Titanium Songer Cable System | Sofamor Danek Mfg., Inc. | 1993 | — |
| 0 (this device) | K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | 1997 | — |
| +1 | K060009 | Abbott Spine Universal Clamp System | Abbott Spine, Inc. | 2006 | — |
| +2 | K081622 | Universal Clamp Stainless Steel System | Abbott Spine, Inc. | 2008 | — |
| +3 | K091190 | Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063 | Zimmer Spine, Inc. | 2009 | — |
| +2 | K110348 | Universal Clamp Spinal Fixation System | Zimmer Spine | 2011 | — |
| +2 | K121541 | Jazz System | Implanet, S.A. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 8 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 JDQ? 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 JDQ device
- #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K925812 | Titanium Songer Cable SystemSummary page 1…97 Predicate Device The Spinal Concepts, Inc. CFIX™ Cable System is claimed to be substantially equivalent in material, design, and function to the Songer™ Cable System K925812. Device Description The Spinal Concepts, Inc. CFIX™ Cable System consists of a flexible, multi strand medical grade titanium al… | 1993 |
What descends from it? (49)
See all 492 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?
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDQ
130in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDQ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDQ
84in 2025
MAUDE reports naming product code JDQ, 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 | 1 | — | 0 | 5 |
| 2008 | 2 | — | 2 | 25 |
| 2009 | 2 | — | 0 | 19 |
| 2010 | 0 | — | 2 | 28 |
| 2011 | 6 | 130 | 0 | 30 |
| 2012 | 3 | 134 | 0 | 130 |
| 2013 | 1 | — | 1 | 321 |
| 2014 | 2 | — | 0 | 223 |
| 2015 | 5 | 92 | 1 | 205 |
| 2016 | 4 | 129 | 0 | 224 |
| 2017 | 1 | — | 0 | 138 |
| 2018 | 6 | 101 | 0 | 182 |
| 2019 | 0 | — | 5 | 158 |
| 2020 | 4 | 93 | 0 | 125 |
| 2021 | 0 | — | 0 | 141 |
| 2022 | 2 | — | 0 | 134 |
| 2023 | 3 | 141 | 0 | 98 |
| 2024 | 3 | 130 | 0 | 115 |
| 2025 | 2 | — | 0 | 84 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Spinal Concepts, Inc. (SCI™) CFIX™ Cable System is a temporary implant for use in orthopedic and cardiovascular surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include, but are not limited to the following applications: Spinal trauma surgery, used in sublaminar, interspinous or facet wiring techniques…
Read the full statement (198 words)
The Spinal Concepts, Inc. (SCI™) CFIX™ Cable System is a temporary implant for use in orthopedic and cardiovascular surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include, but are not limited to the following applications:
Spinal trauma surgery, used in sublaminar, interspinous or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, kyphosis, spondylolisthesis, etc.;
Spinal degenerative surgery, as an adjunct to spinal fusions;
Orthopedic trauma surgery, to secure fractures of the olecranon, patella, femur, humerus, etc. Cables may also be used to reduce and secure dislocations of the acromioclavicular joint;
Orthopaedic reconstructive surgery, to reattach the greater trochanter after trochanteric osteotomy during total hip arthroplasty;
Cardiovascular surgery for closure of the sternum following sternotomy; and
Oral surgery, to repair and fix fractures of the mandible and other facial fractures.
The CFIX™ Cable System may also be used in conjunction with other medical implant grade implants made of titanium alloy (e.g. Luque rods) whenever “wiring” may help secure the attachment of other implants.
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/K974020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974020: Spinal Concepts, Inc., Cfix Cable System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974020
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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