510(k) · Cleared
ClearedJAZZ System, including JAZZ Band
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 Jun 9, 2017 as substantially equivalent to K151740 (Implanet, S.A., 2015) and 2 other predicates after a 92-day review. Its family tree reaches back 15 generations to 2004. 5 later devices descend from it.
- Decided
- Jun 9, 2017
- Review
- 92 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K040583 (2004). 170 ancestors in all, the oldest K781443 (1978). 5 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations between
- 3 generations backK120564 Calypso SystemHogan Lovells US LLP · 2012
- 2 generations backK132303 Implanet Spine SystemImplanet, S.A. · 2013
- 1 generation backK162764 Jazz Frame SystemImplanet, S.A. · 2017
- This deviceK170730 JAZZ System, including JAZZ BandImplanet, S.A. · 2017
- Descendant · cites it directly · 3 of its ownK222097 OLYMPIC Deformity Band SystemAstura Medical · 2023
- Descendant · 2 generations on · 2 of its ownK231694 MASADA Modular Spinal Fixation SystemAstura Medical · 2023
- Descendant · 3 generations on · 0 of its ownK252346 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal…Astura Medical · 2025
- Descendant · 3 generations on · 0 of its ownK243259 MASADA Modular Spinal Fixation SystemAstura Medical · 2025
- Descendant · cites it directly · 0 of its ownK171881 JAZZ Passer BandImplanet, S.A. · 2017
Show all 15 generations
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 12 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 10 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 9 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 7 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 6 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 5 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 4 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 3 generations backK120564 Calypso SystemHogan Lovells US LLP · 2012
- 2 generations backK132303 Implanet Spine SystemImplanet, S.A. · 2013
- 1 generation backK162764 Jazz Frame SystemImplanet, S.A. · 2017
- This deviceK170730 JAZZ System, including JAZZ BandImplanet, S.A. · 2017
Most influential descendants
Showing 5 of 5 · See all- K222097OLYMPIC Deformity Band SystemAstura Medical · 2023 · cites it directly3descendants
- K231694MASADA Modular Spinal Fixation SystemAstura Medical · 2023 · 2 generations on2descendants
- K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2025 · 3 generations on0descendants
- K243259MASADA Modular Spinal Fixation SystemAstura Medical · 2025 · 3 generations on0descendants
- K171881JAZZ Passer BandImplanet, S.A. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −12 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −10 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −9 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −7 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −6 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −5 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −4 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −3 | K120564 | Calypso System | Hogan Lovells US LLP | 2012 | — |
| −2 | K132303 | Implanet Spine System | Implanet, S.A. | 2013 | — |
| −1 | K162764 | Jazz Frame System | Implanet, S.A. | 2017 | — |
| 0 (this device) | K170730 | JAZZ System, including JAZZ Band | Implanet, S.A. | 2017 | — |
| +1 | K222097 | OLYMPIC Deformity Band System | Astura Medical | 2023 | — |
| +2 | K231694 | MASADA Modular Spinal Fixation System | Astura Medical | 2023 | — |
| +3 | K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | 2025 | — |
| +3 | K243259 | MASADA Modular Spinal Fixation System | Astura Medical | 2025 | — |
| +1 | K171881 | JAZZ Passer Band | Implanet, S.A. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 12 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 13 | 0 |
| 2004 | 18 | 0 |
| 2005 | 14 | 0 |
| 2006 | 11 | 0 |
| 2007 | 8 | 0 |
| 2008 | 12 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K151740 | JAZZ SystemSummary page 5…0730 Page 2 of 3 Predicate Devices Implanet’s JAZZ System (K151740) (primary) Implanet’s JAZZ Systems (K162764) (additional) Implanet’s JAZZ Lock (K153348) (additional) Device Des… | 2015 |
| * | K162764 | Jazz Frame SystemSummary page 5…Page 2 of 3 Predicate Devices Implanet’s JAZZ System (K151740) (primary) Implanet’s JAZZ Systems (K162764) (additional) Implanet’s JAZZ Lock (K153348) (additional) Device Description The JAZZ Systems consists of the fo… | 2017 |
| * | K153348 | Jazz LockSummary page 5…Page 2 of 3 Predicate Devices Implanet’s JAZZ System (K151740) (primary) Implanet’s JAZZ Systems (K162764) (additional) Implanet’s JAZZ Lock (K153348) (additional) Device Description The JAZZ Systems consists of the following components: JAZZ Connector, JAZZ Claw… | 2016 |
What descends from it? (5)
2 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 13 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 22 of the 170 ancestors have a recall of any class.
- Of its descendants, K222097 (Astura Medical, 2023) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K151740.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 sublaminar or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of…
Read the full statement (123 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 sublaminar 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 or cobalt-chromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170730: JAZZ System, including JAZZ Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170730
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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