510(k) Report

510(k) · Cleared

Cleared

Jazz Frame System

K162764510(k) TraditionalCleared Jan 19, 2017111-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Implanet, S.A. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jan 19, 2017 as substantially equivalent to K132303 (Implanet, S.A., 2013) and 3 other predicates after a 111-day review. Its family tree reaches back 14 generations to 2004. 6 later devices descend from it.

Decided
Jan 19, 2017
Review
111 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
4

Its longest line of descent runs back 14 generations to K040583 (2004). 166 ancestors in all, the oldest K781443 (1978). 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 2 other ancestors2012: 2 other ancestors2010: 4 other ancestors2014: 2 other ancestors2009: 5 other ancestors2008: 12 other ancestors2007: 8 other ancestors2004: 18 other ancestors2000: 12 other ancestors1988: 1 other ancestor2011: 2 other ancestors2006: 11 other ancestors2001: 13 other ancestors1997: 3 other ancestors1995: 1 other ancestor2013: 1 other ancestor2005: 14 other ancestors2003: 13 other ancestors1998: 6 other ancestors1996: 4 other ancestors1993: 1 other ancestor1992: 1 other ancestor1978: 1 other ancestor2002: 11 other ancestors1999: 2 other ancestors1994: 1 other ancestor1984: 1 other ancestor2017: 2 descendants cleared2023: 2 descendants cleared2025: 2 descendants cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K120564 · Calypso System · Hogan Lovells US LLP · 2012K132303 · Implanet Spine System · Implanet, S.A. · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 10 other ancestors3 generations back: 14 other ancestors4 generations back: 27 other ancestors5 generations back: 37 other ancestors6 generations back: 31 other ancestors7 generations back: 20 other ancestors8 generations back: 10 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 2 descendants K132303 · Implanet Spine System · Implanet, S.A. · 2013K120564 · Calypso System · Hogan Lovells US LLP · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−10−50
  1. Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 10 generations between
  3. 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  4. 2 generations backK120564 Calypso SystemHogan Lovells US LLP · 2012
  5. 1 generation backK132303 Implanet Spine SystemImplanet, S.A. · 2013
  6. This deviceK162764 Jazz Frame SystemImplanet, S.A. · 2017
  7. Descendant · cites it directly · 5 of its ownK170730 JAZZ System, including JAZZ BandImplanet, S.A. · 2017
  8. Descendant · 2 generations on · 3 of its ownK222097 OLYMPIC Deformity Band SystemAstura Medical · 2023
  9. Descendant · 3 generations on · 2 of its ownK231694 MASADA Modular Spinal Fixation SystemAstura Medical · 2023
  10. Descendant · 4 generations on · 0 of its ownK252346 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal…Astura Medical · 2025
  11. Descendant · 4 generations on · 0 of its ownK243259 MASADA Modular Spinal Fixation SystemAstura Medical · 2025
Show all 14 generations
  1. Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 13 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 12 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 11 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 10 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 9 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 8 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 7 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 6 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 5 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 4 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 2 generations backK120564 Calypso SystemHogan Lovells US LLP · 2012
  14. 1 generation backK132303 Implanet Spine SystemImplanet, S.A. · 2013
  15. This deviceK162764 Jazz Frame SystemImplanet, S.A. · 2017

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2017: 22023: 22025: 2
2017high 2 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 6 · 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
  • K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2025 · 4 generations on0descendants
  • K243259MASADA Modular Spinal Fixation SystemAstura Medical · 2025 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−13K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−12K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−11K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−10K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−9K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−8K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−7K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−6K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−5K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−4K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−3K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−2K120564Calypso SystemHogan Lovells US LLP2012—
−1K132303Implanet Spine SystemImplanet, S.A.2013—
0 (this device)K162764Jazz Frame SystemImplanet, S.A.2017—
+1K170730JAZZ System, including JAZZ BandImplanet, S.A.2017—
+2K222097OLYMPIC Deformity Band SystemAstura Medical2023—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical2023—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical2025—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198810
199210
199310
199410
199510
199640
199730
199860
199920
2000120
2001130
2002110
2003130
2004180
2005140
2006110
200780
2008120
200950
201040
201120
201220
201310
201420
201520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
202320
202520
FIG. 1 — Lineage of K162764, 2004–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K132303Implanet Spine System
Summary page 4
…duct Code NKB Regulation Number 21 CFR § 888.3070 Device Class Class II Predicate Devices Implanet S.A.’s Implanet Spine System (ISS) (K132303) (primary) Implanet S.A.’s JAZZ System (K151740) (additional) Renovis S100 Pedicle Screw System (K101682, K111940)…
Implanet, S.A.2013—
*K151740JAZZ System
Summary page 4
…§ 888.3070 Device Class Class II Predicate Devices Implanet S.A.’s Implanet Spine System (ISS) (K132303) (primary) Implanet S.A.’s JAZZ System (K151740) (additional) Renovis S100 Pedicle Screw System (K101682, K111940) (additional) Intended Use / Indications for Use === P…
Implanet, S.A.2015—
*K101682S 100 Pedicle Screw System
Summary page 4
…Implanet S.A.’s Implanet Spine System (ISS) (K132303) (primary) Implanet S.A.’s JAZZ System (K151740) (additional) Renovis S100 Pedicle Screw System (K101682, K111940) (additional) Intended Use / Indications for Use…
Renovis Surgical Technologies, LLC2010—
*K111940S 100 Pedicle Screw System
Summary page 4
…lanet S.A.’s Implanet Spine System (ISS) (K132303) (primary) Implanet S.A.’s JAZZ System (K151740) (additional) Renovis S100 Pedicle Screw System (K101682, K111940) (additional) Intended Use / Indications for Use…
Renovis Surgical Technologies, LLC2012—

Also cleared against K132303: 1 other device →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K170730JAZZ System, including JAZZ BandImplanet, S.A.20175
K171881JAZZ Passer BandImplanet, S.A.20170

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 166 ancestors have a recall of any class.
  • Of its descendants, K170730 (Implanet, S.A., 2017) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K132303.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The Jazz Claw System (hooks and rods) and the Jazz Frame System are 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) and the Jazz Frame System are intended for posterior fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration…

Read the full statement (148 words)

The Jazz Claw System (hooks and rods) and the Jazz Frame System are 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) and the Jazz Frame System are 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 (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis or revision of a failed fusion attempt.

The Jazz Claw System (hooks and rods) and the Jazz Frame System are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Indications for use as stated in the FDA summary.

Also cleared against K132303

1 other device cites the same predicate.

  • K143731IMPLANET Spine System (ISS)Implanet, S.A. · 2015

More from Implanet, S.A.

15 FDA decisions under this applicant name. See the company

  • K230026SqualeImplanet, S.A. · 2023
  • K192084Madison Total Knee SystemImplanet, S.A. · 2019
  • K191217Jazz PFImplanet, S.A. · 2019
  • K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A. · 2019
  • K171881JAZZ Passer BandImplanet, S.A. · 2017

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K162764 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162764: Jazz Frame System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162764

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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