510(k) Report

510(k) · Cleared

Cleared

Implanet Spine System

K132303510(k) TraditionalCleared Oct 10, 201378-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. · OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Cleared on Oct 10, 2013 as substantially equivalent to K120564 (Hogan Lovells US LLP, 2012) and 1 other predicate after a 78-day review. Its family tree reaches back 13 generations to 2004. 15 later devices descend from it.

Decided
Oct 10, 2013
Review
78 days
Class
Class II
Product code
OSH
Recalls
None
Predicates
2

Its longest line of descent runs back 13 generations to K040583 (2004). 144 ancestors in all, the oldest K781443 (1978). 15 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 3 other ancestors2008: 10 other ancestors2000: 10 other ancestors2011: 1 other ancestor2009: 4 other ancestors2007: 7 other ancestors2005: 14 other ancestors2004: 17 other ancestors2003: 13 other ancestors2001: 13 other ancestors1998: 6 other ancestors1997: 2 other ancestors1996: 4 other ancestors1978: 1 other ancestor2006: 10 other ancestors2002: 11 other ancestors1999: 2 other ancestors1995: 1 other ancestor1994: 1 other ancestor1984: 1 other ancestor2015: 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) K120564 · Calypso System · Hogan Lovells US LLP · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors3 generations back: 22 other ancestors4 generations back: 39 other ancestors5 generations back: 30 other ancestors6 generations back: 22 other ancestors7 generations back: 13 other ancestors 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant5 generations forward: 2 descendants K120564 · 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+5
  1. Root · 13 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 9 generations between
  3. 3 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  4. 2 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  5. 1 generation backK120564 Calypso SystemHogan Lovells US LLP · 2012
  6. This deviceK132303 Implanet Spine SystemImplanet, S.A. · 2013
  7. Descendant · cites it directly · 8 of its ownK143731 IMPLANET Spine System (ISS)Implanet, S.A. · 2015
  8. Descendant · cites it directly · 6 of its ownK162764 Jazz Frame SystemImplanet, S.A. · 2017
  9. Descendant · 2 generations on · 5 of its ownK182771 ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A. · 2019
  10. Descendant · 2 generations on · 5 of its ownK170730 JAZZ System, including JAZZ BandImplanet, S.A. · 2017
  11. Descendant · 3 generations on · 3 of its ownK222097 OLYMPIC Deformity Band SystemAstura Medical · 2023
Show all 13 generations
  1. Root · 13 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 12 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 11 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 10 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 9 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 8 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 7 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 6 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 5 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 4 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 3 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 2 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 1 generation backK120564 Calypso SystemHogan Lovells US LLP · 2012
  14. This deviceK132303 Implanet Spine SystemImplanet, S.A. · 2013

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12017: 32019: 22020: 12023: 32024: 12025: 3
2015high 3 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 15 · See all
  • K143731IMPLANET Spine System (ISS)Implanet, S.A. · 2015 · cites it directly8descendants
  • K162764Jazz Frame SystemImplanet, S.A. · 2017 · cites it directly6descendants
  • K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A. · 2019 · 2 generations on5descendants
  • K170730JAZZ System, including JAZZ BandImplanet, S.A. · 2017 · 2 generations on5descendants
  • K222097OLYMPIC Deformity Band SystemAstura Medical · 2023 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−12K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−11K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−10K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−9K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−8K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−7K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−6K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−5K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−4K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−3K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−2K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−1K120564Calypso SystemHogan Lovells US LLP2012—
0 (this device)K132303Implanet Spine SystemImplanet, S.A.2013—
+1K143731IMPLANET Spine System (ISS)Implanet, S.A.2015—
+1K162764Jazz Frame SystemImplanet, S.A.2017—
+2K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.2019—
+2K170730JAZZ System, including JAZZ BandImplanet, S.A.2017—
+3K222097OLYMPIC Deformity Band SystemAstura Medical2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199410
199510
199640
199720
199860
199920
2000100
2001130
2002110
2003130
2004170
2005140
2006100
200770
2008100
200940
201030
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201730
201920
202010
202330
202410
202530
FIG. 1 — Lineage of K132303, 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 OSH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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
*K120564Calypso System
Summary page 1
…Pedicle Fixation Orthosis - NKB, OSH, MVNI, MVNH 558.3050 - Spinal Interlaminal Fixation Orthosis - KWP Predicate Devices Implanet S.A.'s Calypso System (K1 20564) Medtronic Sofamor Danek's CD HORIZON® Spinal System (K091445) Intended Use / Indications for Use The IMPLANET Sp…
Hogan Lovells US LLP2012—
*K091445CD Horizon Spinal System
Summary page 1
…nal Interlaminal Fixation Orthosis - KWP Predicate Devices Implanet S.A.'s Calypso System (K1 20564) Medtronic Sofamor Danek's CD HORIZON® Spinal System (K091445) Intended Use / Indications for Use The IMPLANET Spine System is intended to provide immobilization and stabilization of…
Medtronic Sofamor Danek2010—

Also cleared against K120564: 1 other device →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K143731IMPLANET Spine System (ISS)Implanet, S.A.20158
K162764Jazz Frame SystemImplanet, S.A.20176

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 9 years and passes through 5 companies; a new generation was cleared every 4 months on median.
  • 19 of the 144 ancestors have a recall of any class.
  • Of its descendants, K143731 (Implanet, S.A., 2015) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K120564.

How does its category compare?

All OSH devices

OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · OSH

1in 2016

2012: 32013: 142014: 12016: 1
2007high 14 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OSH

82in 2013

2012: 76 days median2013: 82 days median
2007high 82 (2013) · low 76 (2012)2026

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

Recalls per year · OSH

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OSH

3in 2025

2009: 12011: 12012: 12013: 22014: 12015: 32016: 92017: 42018: 142019: 122020: 122021: 22022: 82023: 182024: 122025: 3
2007high 18 (2023) · low 0 (2007)2025

MAUDE reports naming product code OSH, 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
20070—00
20080—00
20090—01
20100—00
20110—01
201237601
2013148202
20141—01
20150—03
20161—09
20170—14
20180—014
20190—012
20200—012
20210—02
20220—08
20230—018
20240—012
20250—03
20260—0—

What is it indicated for?

The IMPLANET Spine 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 Spine System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…

Read the full statement (140 words)

The IMPLANET Spine 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 Spine System is intended for posterior, non-cervical pedicle and non-pedicle 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.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the IMPLANET Spine System implants 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 K120564

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 OSH

The OSH category page

  • K153446OLYMPIC Posterior Spinal Fixation SystemAstura Medical · 2016
  • K140276CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  • K132574Pass LP Spinal SystemMedicrea International · 2013
  • K132575Pass LP Spinal SystemMedicrea International · 2013
  • K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013

https://510kreport.com/device/K132303 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132303: Implanet Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132303

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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