510(k) · Cleared
ClearedUniversal Clamp Stainless Steel 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 Aug 29, 2008 as substantially equivalent to K060009 (Abbott Spine, Inc., 2006) after an 80-day review. Its family tree reaches back 3 generations to 1993. 46 later devices descend from it.
- Decided
- Aug 29, 2008
- Review
- 80 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K925812 (1993). 46 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 2 generations backK974020 Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997
- 1 generation backK060009 Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006
- This deviceK081622 Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
- Descendant · cites it directly · 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 · 2 generations on · 23 of its ownK142053 Universal Clamp Spinal Fixation SystemZimmer Spine, Inc. · 2014
- Descendant · 2 generations on · 23 of its ownK132395 LigapassMedicrea International · 2013
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K091190Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063Zimmer Spine, Inc. · 2009 · cites it directly45descendants
- K110348Universal Clamp Spinal Fixation SystemZimmer Spine · 2011 · cites it directly44descendants
- K121541Jazz SystemImplanet, S.A. · 2012 · cites it directly27descendants
- K142053Universal Clamp Spinal Fixation SystemZimmer Spine, Inc. · 2014 · 2 generations on23descendants
- K132395LigapassMedicrea International · 2013 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925812 | Titanium Songer Cable System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −2 | K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | 1997 | — |
| −1 | K060009 | Abbott Spine Universal Clamp System | Abbott Spine, Inc. | 2006 | — |
| 0 (this device) | K081622 | Universal Clamp Stainless Steel System | Abbott Spine, Inc. | 2008 | — |
| +1 | 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 | — |
| +2 | K142053 | Universal Clamp Spinal Fixation System | Zimmer Spine, Inc. | 2014 | — |
| +2 | K132395 | Ligapass | Medicrea International | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 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 |
|---|---|---|---|
| * | K060009 | Abbott Spine Universal Clamp SystemSummary page 2…teel System is substantially equivalent to the predicate titanium alloy version cleared in premarket notification K060009. Page 2 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Servi… | 2006 |
What descends from it? (46)
See all 464 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K091190 (Zimmer Spine, Inc., 2009) has gone furthest, with 45 descendants of its own.
- 7 other devices also cite its predicate K060009.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Stainless Steel 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…
Read the full statement (127 words)
The Universal Clamp Stainless Steel 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 Stainless Steel System may also be used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081622 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081622: Universal Clamp Stainless Steel System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081622
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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