510(k) Report

510(k) · Cleared

Cleared

Calypso System

K120564510(k) TraditionalCleared Jul 16, 2012143-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

Hogan Lovells US LLP · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jul 16, 2012 as substantially equivalent to K100623 (Aesculap Implant Systems, 2010) and 1 other predicate after a 143-day review. Its family tree reaches back 12 generations to 2004. 16 later devices descend from it.

Decided
Jul 16, 2012
Review
143 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
2

Its longest line of descent runs back 12 generations to K040583 (2004). 128 ancestors in all, the oldest K841189 (1984). 16 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 2 other ancestors2011: 1 other ancestor2009: 4 other ancestors2008: 8 other ancestors2007: 7 other ancestors2004: 17 other ancestors2003: 12 other ancestors2006: 10 other ancestors2005: 14 other ancestors2002: 11 other ancestors2001: 10 other ancestors2000: 7 other ancestors1999: 2 other ancestors1998: 5 other ancestors1997: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1996: 2 other ancestors1984: 1 other ancestor2015: 1 descendant cleared2013: 1 descendant cleared2017: 3 descendants cleared2016: 1 descendant cleared2024: 1 descendant cleared2019: 2 descendants cleared2023: 3 descendants cleared2020: 1 descendant cleared2025: 3 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) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 10 other ancestors3 generations back: 37 other ancestors4 generations back: 32 other ancestors5 generations back: 23 other ancestors6 generations back: 13 other ancestors 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 6 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 2 descendants K113174 · 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+5
  1. Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 8 generations between
  3. 3 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  4. 2 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  5. 1 generation backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  6. This deviceK120564 Calypso SystemHogan Lovells US LLP · 2012
  7. Descendant · cites it directly · 15 of its ownK132303 Implanet Spine SystemImplanet, S.A. · 2013
  8. Descendant · cites it directly · 8 of its ownK143731 IMPLANET Spine System (ISS)Implanet, S.A. · 2015
  9. Descendant · 2 generations on · 6 of its ownK162764 Jazz Frame SystemImplanet, S.A. · 2017
  10. Descendant · 2 generations on · 5 of its ownK182771 ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A. · 2019
  11. Descendant · 3 generations on · 5 of its ownK170730 JAZZ System, including JAZZ BandImplanet, S.A. · 2017
Show all 12 generations
  1. Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 11 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 10 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 9 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 8 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 7 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 6 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 5 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 4 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 3 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 2 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 1 generation backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. This deviceK120564 Calypso SystemHogan Lovells US LLP · 2012

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2013: 12015: 12016: 12017: 32019: 22020: 12023: 32024: 12025: 3
2013high 3 (2017) · low 0 (2014)2026

Most influential descendants

Showing 5 of 16 · See all
  • K132303Implanet Spine SystemImplanet, S.A. · 2013 · cites it directly15descendants
  • K143731IMPLANET Spine System (ISS)Implanet, S.A. · 2015 · cites it directly8descendants
  • K162764Jazz Frame SystemImplanet, S.A. · 2017 · 2 generations on6descendants
  • K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A. · 2019 · 2 generations on5descendants
  • K170730JAZZ System, including JAZZ BandImplanet, S.A. · 2017 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−11K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−10K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−9K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−8K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−7K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−6K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−5K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−4K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−3K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−2K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−1K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
0 (this device)K120564Calypso SystemHogan Lovells US LLP2012—
+1K132303Implanet Spine SystemImplanet, S.A.2013—
+1K143731IMPLANET Spine System (ISS)Implanet, S.A.2015—
+2K162764Jazz Frame SystemImplanet, S.A.2017—
+2K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.2019—
+3K170730JAZZ System, including JAZZ BandImplanet, S.A.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199410
199510
199620
199710
199850
199920
200070
2001100
2002110
2003120
2004170
2005140
2006100
200770
200880
200940
201020
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201510
201610
201730
201920
202010
202330
202410
202530
FIG. 1 — Lineage of K120564, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K100623Aesculap Implant Systems S4 Spinal System
Summary page 1
…8.3070 - Pedicle Screw Spinal System 888.3050 - Spinal interlaminal fixation orthosis Predicate Devices Aesculap Implant Systems, Inc.'s S4 Spinal System (K100623) Medtronic Sofamor Danek USA, Inc.'s CID HORIZON Spinal System (K1 131 74) Intended Use / Indications for Use The…
Aesculap Implant Systems20101
*K113174CD Horizon Spinal System
Summary page 1
…ion orthosis Predicate Devices Aesculap Implant Systems, Inc.'s S4 Spinal System (K100623) Medtronic Sofamor Danek USA, Inc.'s CID HORIZON Spinal System (K1 131 74) Intended Use / Indications for Use The Implanet Calypso System is intended to provide immobilization and stabilization o…
Medtronic Sofamor Danek USA, Inc.20111

Also cleared against K100623: 4 other devices →

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K132303Implanet Spine SystemImplanet, S.A.201315
K143731IMPLANET Spine System (ISS)Implanet, S.A.20158

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 8 years and passes through 4 companies; a new generation was cleared every 4 months on median.
  • 19 of the 128 ancestors have a recall of any class.
  • Of its descendants, K132303 (Implanet, S.A., 2013) has gone furthest, with 15 descendants of its own.
  • 4 other devices also cite its predicate K100623.

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. 2012, 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 Implanet Calypso System 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 Implanet Calypso System is intended for posterior, non-cervical pedicle and non-pedlicle 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, pseudoarthrosis, or revision of a failed fusion attempt.

Indications for use as stated in the FDA summary.

Also cleared against K100623

4 other devices cite the same predicate.

  • K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2016
  • K123939S4 Spinal SystemAesculap Implant Systems, Inc. · 2013
  • K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd. · 2013
  • K112551S4 Spinal SystemAesculap Implant System, Inc. · 2011

More from Hogan Lovells US LLP

3 FDA decisions under this applicant name. See the company

  • K122358NoveonHogan Lovells US LLP · 2014
  • K132287Jazz SystemHogan Lovells US LLP · 2013

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/K120564 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120564: Calypso System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120564

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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