510(k) · Cleared
ClearedJazz Lock
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 Mar 31, 2016 as substantially equivalent to K922952 (Pioneer Surgical Technology, 1993) and 1 other predicate after a 132-day review. Its family tree reaches back 1 generation to 1993. 10 later devices descend from it.
- Decided
- Mar 31, 2016
- Review
- 132 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922952 (1993). 2 ancestors in all. 10 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK922952 Songer Cable SystemPioneer Surgical Technology · 1993
- This deviceK153348 Jazz LockImplanet, S.A. · 2016
- Descendant · cites it directly · 5 of its ownK170730 JAZZ System, including JAZZ BandImplanet, S.A. · 2017
- Descendant · 2 generations on · 3 of its ownK222097 OLYMPIC Deformity Band SystemAstura Medical · 2023
- Descendant · 3 generations on · 2 of its ownK231694 MASADA Modular Spinal Fixation SystemAstura Medical · 2023
- Descendant · cites it directly · 1 of its ownK180728 Spinal Elements Cerclage SystemSpinal Elements, Inc. · 2018
- Descendant · 4 generations on · 0 of its ownK252346 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal…Astura Medical · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K170730JAZZ System, including JAZZ BandImplanet, S.A. · 2017 · cites it directly5descendants
- K222097OLYMPIC Deformity Band SystemAstura Medical · 2023 · 2 generations on3descendants
- K231694MASADA Modular Spinal Fixation SystemAstura Medical · 2023 · 3 generations on2descendants
- K180728Spinal Elements Cerclage SystemSpinal Elements, Inc. · 2018 · cites it directly1descendant
- K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922952 | Songer Cable System | Pioneer Surgical Technology | 1993 | — |
| 0 (this device) | K153348 | Jazz Lock | Implanet, S.A. | 2016 | — |
| +1 | K170730 | JAZZ System, including JAZZ Band | Implanet, S.A. | 2017 | — |
| +2 | K222097 | OLYMPIC Deformity Band System | Astura Medical | 2023 | — |
| +3 | K231694 | MASADA Modular Spinal Fixation System | Astura Medical | 2023 | — |
| +1 | K180728 | Spinal Elements Cerclage System | Spinal Elements, Inc. | 2018 | — |
| +4 | K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | 2025 | — |
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 |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 3 | 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 |
|---|---|---|---|
| * | K922952 | Songer Cable SystemSummary page 4…roduct Code: OWI- bone fixation cerclage, sublaminar, Class II Predicate and Reference Devices Pioneer Surgical (now RTI Surgical)’s Songer Spinal Cable (K922952, K941213) (primary) Implanet S.A.’s JAZZ System (K151740) (additional) Intended Use / Indications for Use The JAZ… | 1993 |
| * | K941213 | Songer Cable SystemSummary page 4…de: OWI- bone fixation cerclage, sublaminar, Class II Predicate and Reference Devices Pioneer Surgical (now RTI Surgical)’s Songer Spinal Cable (K922952, K941213) (primary) Implanet S.A.’s JAZZ System (K151740) (additional) Intended Use / Indications for Use The JAZZ LOCK is… | 1994 |
| † | K151740 | JAZZ System | 2015 |
What descends from it? (10)
5 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?
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 LOCK is a temporary implant to be used in orthopedic surgery. JAZZ LOCK is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. JAZZ LOCK is designed for a posterior approach. The indications for use include the following applications:
• Spinal trauma surgery: Jazz Lock implants can be used in sublaminar wiring technique
• Spinal degenerative surgery: Jazz Lock 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/K153348 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153348: Jazz Lock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153348
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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