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, Inc. · OWI Bone Fixation Cerclage, Sublaminar
Cleared on Oct 29, 2014 as substantially equivalent to K110348 (Zimmer Spine, 2011) and 3 other predicates after a 92-day review. Its family tree reaches back 6 generations to 1993. 23 later devices descend from it.
- Decided
- Oct 29, 2014
- Review
- 92 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K925812 (1993). 26 ancestors in all, the oldest K781443 (1978). 23 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 5 generations backK974020 Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997
- 4 generations backK060009 Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006
- 3 generations backK081622 Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
- 2 generations backK091190 Universal Clamp Stainless Steel System, Models SNA027-0-30060…Zimmer Spine, Inc. · 2009
- 1 generation backK110348 Universal Clamp Spinal Fixation SystemZimmer Spine · 2011
- This deviceK142053 Universal Clamp Spinal Fixation SystemZimmer Spine, Inc. · 2014
- Descendant · cites it directly · 12 of its ownK160698 LigaPASSMedicrea International SA · 2016
- Descendant · cites it directly · 12 of its ownK151740 JAZZ SystemImplanet, S.A. · 2015
- Descendant · 2 generations on · 11 of its ownK172021 LigaPASSMedicrea International SA · 2017
- Descendant · 3 generations on · 9 of its ownK173506 LigaPASSMedicrea International SA · 2018
- Descendant · 2 generations on · 6 of its ownK162764 Jazz Frame SystemImplanet, S.A. · 2017
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K160698LigaPASSMedicrea International SA · 2016 · cites it directly12descendants
- K151740JAZZ SystemImplanet, S.A. · 2015 · cites it directly12descendants
- K172021LigaPASSMedicrea International SA · 2017 · 2 generations on11descendants
- K173506LigaPASSMedicrea International SA · 2018 · 3 generations on9descendants
- K162764Jazz Frame SystemImplanet, S.A. · 2017 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K925812 | Titanium Songer Cable System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −5 | K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | 1997 | — |
| −4 | K060009 | Abbott Spine Universal Clamp System | Abbott Spine, Inc. | 2006 | — |
| −3 | 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 | — |
| 0 (this device) | K142053 | Universal Clamp Spinal Fixation System | Zimmer Spine, Inc. | 2014 | — |
| +1 | K160698 | LigaPASS | Medicrea International SA | 2016 | — |
| +1 | K151740 | JAZZ System | Implanet, S.A. | 2015 | — |
| +2 | K172021 | LigaPASS | Medicrea International SA | 2017 | — |
| +3 | K173506 | LigaPASS | Medicrea International SA | 2018 | — |
| +2 | K162764 | Jazz Frame System | Implanet, S.A. | 2017 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110348 | Universal Clamp Spinal Fixation SystemSummary page 4…Zimmer Spine Universal Clamp Spinal Fixation System (K110348*, K091190, . K060009)… | 2011 |
| * | K091190 | Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063Summary page 4…Zimmer Spine Universal Clamp Spinal Fixation System (K110348*, K091190, . K060009)… | 2009 |
| Kept off the family tree | K081622 | FDA’s K081622 is Universal Clamp Stainless Steel System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| * | K060009 | Abbott Spine Universal Clamp SystemSummary page 4…System (K110348*, K091190, . K060009) Spinal Concepts CFIX Cable System… | 2006 |
| * | K974020 | Spinal Concepts, Inc., Cfix Cable SystemSummary page 4…Spinal Concepts CFIX Cable System (K974020) SULPDU\SUHGLFDWH General Device Description: The Univ… | 1997 |
What descends from it? (23)
See all 235 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 21 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K160698 (Medicrea International SA, 2016) has gone furthest, with 12 descendants of its own.
- 8 other devices also cite its predicate K110348.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 System may also be used in conjunction with other medical grade implants made of similar metals whenever “wiring” may help secure the attachment of the other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142053: 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/K142053
Report an extraction error
Are you the manufacturer?
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