510(k) · Cleared
ClearedSpinal Elements Cerclage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Elements, Inc. · OWI Bone Fixation Cerclage, Sublaminar
Cleared on Sep 6, 2018 as substantially equivalent to K153348 (Implanet, S.A., 2016) after a 170-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Sep 6, 2018
- Review
- 170 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922952 (1993). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK922952 Songer Cable SystemPioneer Surgical Technology · 1993
- 1 generation backK153348 Jazz LockImplanet, S.A. · 2016
- This deviceK180728 Spinal Elements Cerclage SystemSpinal Elements, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK190289 Karma® Fixation SystemSpinal Elements, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190289Karma® Fixation SystemSpinal Elements, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922952 | Songer Cable System | Pioneer Surgical Technology | 1993 | — |
| −1 | K153348 | Jazz Lock | Implanet, S.A. | 2016 | — |
| 0 (this device) | K180728 | Spinal Elements Cerclage System | Spinal Elements, Inc. | 2018 | — |
| +1 | K190289 | Karma® Fixation System | Spinal Elements, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 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? (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 |
|---|---|---|---|
| * | K153348 | Jazz LockSummary page 5…allograft) at level(s) of use. Substantial Equivalence The subject device is substantially equivalent to the primary predicate device Implanet Jazz Lock cleared in K153348. Technological Characteristics The subject device was established as substantially equivalent to other predicate devices cleared… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190289 | Karma® Fixation System | 2019 | 0 |
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 25 years and passes through 3 companies; a new generation was cleared every 23.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K190289 (Spinal Elements, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K153348.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Spinal Elements Cerclage System is intended for use in cardiovascular surgery. The indications for use include cardiovascular surgery for closure of the sternum following sternotomy. The system is intended to provide temporary stabilization during the development of solid bony fusion. The Spinal Elements Cerclage System is a temporary implant to be used in orthopedic surgery. The Spinal Elements Cerclage System is a bony anchor designed to provide…
Read the full statement (144 words)
The Spinal Elements Cerclage System is intended for use in cardiovascular surgery. The indications for use include cardiovascular surgery for closure of the sternum following sternotomy. The system is intended to provide temporary stabilization during the development of solid bony fusion.
The Spinal Elements Cerclage System is a temporary implant to be used in orthopedic surgery. The Spinal Elements Cerclage System is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. The Spinal Elements Cerclage System is designed for a posterior approach. The indications for use include the following applications:
1. Spinal trauma surgery: The Spinal Elements Cerclage implants can be used in sublaminar wiring techniques;
2. Spinal degenerative surgery: The Spinal Elements Cerclage implants may be used as an adjunct to spinal fusions with bone graft (autograft or allograft) at level(s) of use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180728 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180728: Spinal Elements Cerclage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180728
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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