510(k) · Cleared
ClearedAbbott Spine Universal Clamp System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Spine, Inc. · JDQ Cerclage, Fixation
Cleared on Mar 6, 2006 as substantially equivalent to K974020 (Spinal Concepts, Inc., 1997) after a 62-day review. Its family tree reaches back 2 generations to 1993. 48 later devices descend from it.
- Decided
- Mar 6, 2006
- Review
- 62 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925812 (1993). 48 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 1 generation backK974020 Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997
- This deviceK060009 Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006
- Descendant · cites it directly · 46 of its ownK081622 Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
- Descendant · 2 generations on · 45 of its ownK091190 Universal Clamp Stainless Steel System, Models SNA027-0-30060…Zimmer Spine, Inc. · 2009
- Descendant · cites it directly · 44 of its ownK110348 Universal Clamp Spinal Fixation SystemZimmer Spine · 2011
- Descendant · cites it directly · 27 of its ownK121541 Jazz SystemImplanet, S.A. · 2012
- Descendant · cites it directly · 25 of its ownK112736 Pass LP SpinalMedicrea International · 2012
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K081622Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008 · cites it directly46descendants
- K091190Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063Zimmer Spine, Inc. · 2009 · 2 generations on45descendants
- K110348Universal Clamp Spinal Fixation SystemZimmer Spine · 2011 · cites it directly44descendants
- K121541Jazz SystemImplanet, S.A. · 2012 · cites it directly27descendants
- K112736Pass LP SpinalMedicrea International · 2012 · cites it directly25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925812 | Titanium Songer Cable System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −1 | K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | 1997 | — |
| 0 (this device) | K060009 | Abbott Spine Universal Clamp System | Abbott Spine, Inc. | 2006 | — |
| +1 | K081622 | Universal Clamp Stainless Steel System | Abbott Spine, Inc. | 2008 | — |
| +2 | K091190 | Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063 | Zimmer Spine, Inc. | 2009 | — |
| +1 | K110348 | Universal Clamp Spinal Fixation System | Zimmer Spine | 2011 | — |
| +1 | K121541 | Jazz System | Implanet, S.A. | 2012 | — |
| +1 | K112736 | Pass LP Spinal | Medicrea International | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K974020 | Spinal Concepts, Inc., Cfix Cable SystemSummary page 4…CLASSIFICATION NAME: Bone Fixation Cerclage CLASSIFICATION REFERENCE: 21 CFR § 888.3010 PREDICATE DEViCE: CFix Cable System (K974020) DEVICE DESCRIPTION: The Universal Clamp System is a temporary orthopedic impl… | 1997 |
What descends from it? (48)
See all 488 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081622 | Universal Clamp Stainless Steel System | 2008 | 46 |
| K110348 | Universal Clamp Spinal Fixation System | 2011 | 44 |
| K121541 | Jazz System | 2012 | 27 |
| K112736 | Pass LP Spinal | 2012 | 25 |
| K142053 | Universal Clamp Spinal Fixation System | 2014 | 23 |
| K133482 | Silc Fixation System | 2014 | 11 |
| K143350 | Nile Alternative Fixation | 2015 | 10 |
| K161267 | Response BandLoc Spinal Fixation | 2016 | 1 |
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 13 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K081622 (Abbott Spine, Inc., 2008) has gone furthest, with 46 descendants of its own.
- 1 other device also cites its predicate K974020.
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 Universal Clamp System is a temporary implant for use in orthopedic 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 factures. The indications for use include, but are not limited to, the following applications: 1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; 2. Spinal reconstructive surgery…
Read the full statement (123 words)
The Universal Clamp System is a temporary implant for use in orthopedic 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 factures. The indications for use include, but are not limited to, the following applications:
1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, kyphosis, spondylolisthesis;
3. Spinal degenerative surgery, as an adjunct to spinal fusions;
The Universal Clamp System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060009 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060009: Abbott Spine Universal Clamp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060009
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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