510(k) · Cleared
ClearedJazz System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implanet, S.A. · OWI Bone Fixation Cerclage, Sublaminar
Cleared on Feb 20, 2014 as substantially equivalent to K132287 (Hogan Lovells US LLP, 2013) and 1 other predicate after an 87-day review. Its family tree reaches back 8 generations to 1993. 14 later devices descend from it.
- Decided
- Feb 20, 2014
- Review
- 87 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K925812 (1993). 28 ancestors in all, the oldest K781443 (1978). 14 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 7 generations backK974020 Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997
- 6 generations backK060009 Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006
- 5 generations backK081622 Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
- 4 generations backK091190 Universal Clamp Stainless Steel System, Models SNA027-0-30060…Zimmer Spine, Inc. · 2009
- 3 generations backK110348 Universal Clamp Spinal Fixation SystemZimmer Spine · 2011
- 2 generations backK121541 Jazz SystemImplanet, S.A. · 2012
- 1 generation backK132287 Jazz SystemHogan Lovells US LLP · 2013
- This deviceK133617 Jazz SystemImplanet, S.A. · 2014
- Descendant · cites it directly · 13 of its ownK143759 JAZZ SystemImplanet, S.A. · 2015
- Descendant · 2 generations on · 12 of its ownK151740 JAZZ SystemImplanet, S.A. · 2015
- Descendant · 3 generations on · 6 of its ownK162764 Jazz Frame SystemImplanet, S.A. · 2017
- Descendant · 3 generations on · 5 of its ownK170730 JAZZ System, including JAZZ BandImplanet, S.A. · 2017
- Descendant · 4 generations on · 3 of its ownK222097 OLYMPIC Deformity Band SystemAstura Medical · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K143759JAZZ SystemImplanet, S.A. · 2015 · cites it directly13descendants
- K151740JAZZ SystemImplanet, S.A. · 2015 · 2 generations on12descendants
- K162764Jazz Frame SystemImplanet, S.A. · 2017 · 3 generations on6descendants
- K170730JAZZ System, including JAZZ BandImplanet, S.A. · 2017 · 3 generations on5descendants
- K222097OLYMPIC Deformity Band SystemAstura Medical · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K925812 | Titanium Songer Cable System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −7 | K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | 1997 | — |
| −6 | K060009 | Abbott Spine Universal Clamp System | Abbott Spine, Inc. | 2006 | — |
| −5 | K081622 | Universal Clamp Stainless Steel System | Abbott Spine, Inc. | 2008 | — |
| −4 | K091190 | Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063 | Zimmer Spine, Inc. | 2009 | — |
| −3 | K110348 | Universal Clamp Spinal Fixation System | Zimmer Spine | 2011 | — |
| −2 | K121541 | Jazz System | Implanet, S.A. | 2012 | — |
| −1 | K132287 | Jazz System | Hogan Lovells US LLP | 2013 | — |
| 0 (this device) | K133617 | Jazz System | Implanet, S.A. | 2014 | — |
| +1 | K143759 | JAZZ System | Implanet, S.A. | 2015 | — |
| +2 | K151740 | JAZZ System | Implanet, S.A. | 2015 | — |
| +3 | K162764 | Jazz Frame System | Implanet, S.A. | 2017 | — |
| +3 | K170730 | JAZZ System, including JAZZ Band | Implanet, S.A. | 2017 | — |
| +4 | K222097 | OLYMPIC Deformity Band System | Astura Medical | 2023 | — |
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 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2019 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K132287 | Jazz SystemSummary page 1…m Common Name)/ Classification Name Bone fixation cerclage (21 C.F.R. 888.3030, Class 11)(Product Code: OWl) Predicate Devices Implanet S.A.'s JAZZ System (K132287; K121541) Purpose of the Special 510(k) Notice The subject device isa modification to cleared JAZZ System. Specifically, th… | 2013 |
| * | K121541 | Jazz SystemSummary page 1…Name)/ Classification Name Bone fixation cerclage (21 C.F.R. 888.3030, Class 11)(Product Code: OWl) Predicate Devices Implanet S.A.'s JAZZ System (K132287; K121541) Purpose of the Special 510(k) Notice The subject device isa modification to cleared JAZZ System. Specifically, the propose… | 2012 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143759 | JAZZ System | 2015 | 13 |
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 7 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K143759 (Implanet, S.A., 2015) has gone furthest, with 13 descendants of its own.
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?
JAZZ is a temporary Implant to be used in orthopedic surgery. The JAZZ 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 sublamninar or facet wiring techniques; 2 Spinal reconstructive surgery. Incorporated Into constructs for the purpose of correction of…
Read the full statement (133 words)
JAZZ is a temporary Implant to be used in orthopedic surgery. The JAZZ 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 sublamninar or facet wiring techniques;
2 Spinal reconstructive surgery. Incorporated Into constructs for the purpose of correction of spinal deformities such as adolescent Idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
3 Spinal degenerative surgery, as an adjunct to spinal fusions.
The JAZZ 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.
The JAZZ System is intended to be used with the Implanet Spine System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133617: Jazz System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133617
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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