510(k) · Cleared
ClearedUniversal Clamp Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine · OWI Bone Fixation Cerclage, Sublaminar
Cleared on Aug 11, 2011 as substantially equivalent to K091190 (Zimmer Spine, Inc., 2009) and 6 other predicates after a 185-day review. Its family tree reaches back 5 generations to 1993. 44 later devices descend from it.
- Decided
- Aug 11, 2011
- Review
- 185 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 5 generations to K925812 (1993). 25 ancestors in all, the oldest K781443 (1978). 44 later devices descend from it, 9 citing it directly.
- Root · 5 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 4 generations backK974020 Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997
- 3 generations backK060009 Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006
- 2 generations backK081622 Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
- 1 generation backK091190 Universal Clamp Stainless Steel System, Models SNA027-0-30060…Zimmer Spine, Inc. · 2009
- This deviceK110348 Universal Clamp Spinal Fixation SystemZimmer Spine · 2011
- Descendant · cites it directly · 27 of its ownK121541 Jazz SystemImplanet, S.A. · 2012
- Descendant · cites it directly · 23 of its ownK142053 Universal Clamp Spinal Fixation SystemZimmer Spine, Inc. · 2014
- Descendant · cites it directly · 23 of its ownK132395 LigapassMedicrea International · 2013
- Descendant · cites it directly · 15 of its ownK132287 Jazz SystemHogan Lovells US LLP · 2013
- Descendant · 2 generations on · 14 of its ownK133617 Jazz SystemImplanet, S.A. · 2014
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K121541Jazz SystemImplanet, S.A. · 2012 · cites it directly27descendants
- K142053Universal Clamp Spinal Fixation SystemZimmer Spine, Inc. · 2014 · cites it directly23descendants
- K132395LigapassMedicrea International · 2013 · cites it directly23descendants
- K132287Jazz SystemHogan Lovells US LLP · 2013 · cites it directly15descendants
- K133617Jazz SystemImplanet, S.A. · 2014 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925812 | Titanium Songer Cable System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −4 | K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | 1997 | — |
| −3 | K060009 | Abbott Spine Universal Clamp System | Abbott Spine, Inc. | 2006 | — |
| −2 | 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 | — |
| 0 (this device) | K110348 | Universal Clamp Spinal Fixation System | Zimmer Spine | 2011 | — |
| +1 | K121541 | Jazz System | Implanet, S.A. | 2012 | — |
| +1 | K142053 | Universal Clamp Spinal Fixation System | Zimmer Spine, Inc. | 2014 | — |
| +1 | K132395 | Ligapass | Medicrea International | 2013 | — |
| +1 | K132287 | Jazz System | Hogan Lovells US LLP | 2013 | — |
| +2 | K133617 | Jazz System | Implanet, S.A. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OWI? 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 OWI device
- #1 K253615 Invictus Bands Systemscore 20.7 · 33 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K091190 | Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063Summary page 1…mber: 21 CFR 888.3010 Device Classification: Class 11 Predicate Devices: Universal Clamp® Spinal Fixation System K091190, K081622, K060009 DePuy AcroMed ISOLA System K96298… | 2009 |
| * | K081622 | Universal Clamp Stainless Steel SystemSummary page 1…e Classification: Class 11 Predicate Devices: Universal Clamp® Spinal Fixation System K091190, K081622, K060009 DePuy AcroMed ISOLA System K962984 Medtron… | 2008 |
| * | K060009 | Abbott Spine Universal Clamp SystemSummary page 1…ication: Class 11 Predicate Devices: Universal Clamp® Spinal Fixation System K091190, K081622, K060009 DePuy AcroMed ISOLA System K962984 Medtronic CID Ho… | 2006 |
| * | K962984 | Isola Pediatric ComponentsSummary page 1…niversal Clamp® Spinal Fixation System K091190, K081622, K060009 DePuy AcroMed ISOLA System K962984 Medtronic CID Horizon Spinal System K091445 Synthes… | 1996 |
| * | K091445 | CD Horizon Spinal SystemSummary page 1…K081622, K060009 DePuy AcroMed ISOLA System K962984 Medtronic CID Horizon Spinal System K091445 Synthes USS Small Stature K994121 Luque Segmental S… | 2010 |
| * | K994121 | Small Stature UssSummary page 1…ISOLA System K962984 Medtronic CID Horizon Spinal System K091445 Synthes USS Small Stature K994121 Luque Segmental Spinal Instrumentation K91 3561 Description of Device: The Universal Cl… | 2000 |
| * | K913561 | Luque Segmental Spinal InstrumentationSummary page 1…nal System K091445 Synthes USS Small Stature K994121 Luque Segmental Spinal Instrumentation K91 3561 Description of Device: The Universal Clamp® Spinal Fixation System is a temporary orthopedic implant intended to provide stab… | 1992 |
What descends from it? (44)
See all 449 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121541 | Jazz System | 2012 | 27 |
| K142053 | Universal Clamp Spinal Fixation System | 2014 | 23 |
| K132395 | Ligapass | 2013 | 23 |
| K132287 | Jazz System | 2013 | 15 |
| K133482 | Silc Fixation System | 2014 | 11 |
| K143350 | Nile Alternative Fixation | 2015 | 10 |
| K172206 | NAJA™ Ligament Correction System | 2018 | 2 |
| K163181 | TRANSLACE™ Spinal Tethering System | 2017 | 2 |
| 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 18 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K121541 (Implanet, S.A., 2012) has gone furthest, with 27 descendants of its own.
- 2 other devices also cite its predicate K091190.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OWI
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OWI
60in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWI
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWI
6in 2025
MAUDE reports naming product code OWI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 92 | 0 | 1 |
| 2015 | 3 | 93 | 0 | 1 |
| 2016 | 5 | 98 | 0 | 6 |
| 2017 | 7 | 77 | 0 | 6 |
| 2018 | 4 | 156 | 0 | 2 |
| 2019 | 3 | 51 | 0 | 13 |
| 2020 | 3 | 60 | 1 | 8 |
| 2021 | 1 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Universal Clamp® Spinal Fixation 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 fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into constructs for…
Read the full statement (135 words)
The Universal Clamp® Spinal Fixation 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 fractures. The indications for use include the following applications:
1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
3. Spinal degenerative surgery, as an adjunct to spinal fusions.
The Universal Clamp® Spinal Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110348: Universal Clamp Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110348
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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