510(k) · Cleared
ClearedJAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implanet, S.A. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on May 18, 2016 as substantially equivalent to K151740 (Implanet, S.A., 2015) and 2 other predicates after a 110-day review. Its family tree reaches back 15 generations to 2004. 1 later device descends from it.
- Decided
- May 18, 2016
- Review
- 110 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K040583 (2004). 160 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 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 backK143731 IMPLANET Spine System (ISS)Implanet, S.A. · 2015
- This deviceK160226 JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A. · 2016
- 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 backK143731 IMPLANET Spine System (ISS)Implanet, S.A. · 2015
- This deviceK160226 JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A. · 2016
Most influential descendants
Showing 1 of 1 · See all- 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 | K143731 | IMPLANET Spine System (ISS) | Implanet, S.A. | 2015 | — |
| 0 (this device) | K160226 | JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector | Implanet, S.A. | 2016 | — |
| +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 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 10 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 14 | 0 |
| 2004 | 17 | 0 |
| 2005 | 14 | 0 |
| 2006 | 11 | 0 |
| 2007 | 7 | 0 |
| 2008 | 11 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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…ct Codes: NKB, OSH, MNI, MNH; 21 CFR § 888.3050, Spinal interlaminal fixation orthosis ; Product Code: KWP Predicate and Reference Devices 1. Implanet S.A. JAZZ System (K151740) (primary predicate for JAZZ CLAW connector) 2. Implanet S.A. Spinal System (K143731) (primary predicate for JAZZ CLAW System (ho… | 2015 |
| * | K143731 | IMPLANET Spine System (ISS)Summary page 5…s ; Product Code: KWP Predicate and Reference Devices 1. Implanet S.A. JAZZ System (K151740) (primary predicate for JAZZ CLAW connector) 2. Implanet S.A. Spinal System (K143731) (primary predicate for JAZZ CLAW System (hooks and rods)); Synthes Cervifix System (K030377) (reference for JAZZ CLAW System (ho… | 2015 |
| * | K030377 | Modification to Synthes Cervifix SystemSummary page 5…(primary predicate for JAZZ CLAW connector) 2. Implanet S.A. Spinal System (K143731) (primary predicate for JAZZ CLAW System (hooks and rods)); Synthes Cervifix System (K030377) (reference for JAZZ CLAW System (hooks and rods)) Intended Use | Indications for Use 1. The JAZZ CLAW connector consists of temp… | 2003 |
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 |
|---|---|---|---|
| K171881 | JAZZ Passer Band | 2017 | 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 12 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 19 of the 160 ancestors have a recall of any class.
- Of its descendants, K171881 (Implanet, S.A., 2017) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K151740.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The JAZZ CLAW System (hooks and rods) is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Jazz Claw System (hooks and rods) is intended for posterior fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic…
Read the full statement (248 words)
The JAZZ CLAW System (hooks and rods) is intended to provide immobilization and stabilization of spinal segments
in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Jazz Claw
System (hooks and rods) is intended for posterior fixation for the following indications:
degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed
by history and radiographic studies);
spondylolisthesis;
trauma (fracture or dislocation);
spinal stenosis;
spinal deformities (scoliosis, kyphosis and/or lordlosis)
tumor;
pseudarthrosis; and
revision of a failed fusion attempt.
The Jazz Claw System (hooks and rods) is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis.
These devices are to be used with autograft and/or allograft.
The JAZZ CLAW connector consists of temporary implants to be used in orthopedic surgery. The JAZZ CLAW
connector 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;
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 CLAW connector 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160226: JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160226
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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