510(k) · Cleared
ClearedIMPLANET Spine System (ISS)
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 Apr 14, 2015 as substantially equivalent to K120564 (Hogan Lovells US LLP, 2012) and 1 other predicate after a 106-day review. Its family tree reaches back 14 generations to 2004. 8 later devices descend from it.
- Decided
- Apr 14, 2015
- Review
- 106 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K040583 (2004). 145 ancestors in all, the oldest K781443 (1978). 8 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations between
- 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 2 generations backK120564 Calypso SystemHogan Lovells US LLP · 2012
- 1 generation backK132303 Implanet Spine SystemImplanet, S.A. · 2013
- This deviceK143731 IMPLANET Spine System (ISS)Implanet, S.A. · 2015
- Descendant · cites it directly · 5 of its ownK182771 ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A. · 2019
- Descendant · cites it directly · 1 of its ownK240392 JAZZ Spinal SystemImplanet · 2024
- Descendant · cites it directly · 1 of its ownK160226 JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A. · 2016
- Descendant · 2 generations on · 0 of its ownK252437 JAZZ Spinal SystemImplanet · 2025
- Descendant · 2 generations on · 0 of its ownK230565 HILINE™ Fixation SystemGlobus Medical, Inc. · 2023
Show all 14 generations
- Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 11 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 9 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 8 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 7 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 6 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 5 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 4 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 2 generations backK120564 Calypso SystemHogan Lovells US LLP · 2012
- 1 generation backK132303 Implanet Spine SystemImplanet, S.A. · 2013
- This deviceK143731 IMPLANET Spine System (ISS)Implanet, S.A. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A. · 2019 · cites it directly5descendants
- K240392JAZZ Spinal SystemImplanet · 2024 · cites it directly1descendant
- K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A. · 2016 · cites it directly1descendant
- K252437JAZZ Spinal SystemImplanet · 2025 · 2 generations on0descendants
- K230565HILINE™ Fixation SystemGlobus Medical, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −11 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −9 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −8 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −7 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −6 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −5 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −4 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −3 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −2 | K120564 | Calypso System | Hogan Lovells US LLP | 2012 | — |
| −1 | K132303 | Implanet Spine System | Implanet, S.A. | 2013 | — |
| 0 (this device) | K143731 | IMPLANET Spine System (ISS) | Implanet, S.A. | 2015 | — |
| +1 | K182771 | ISS-JAZZ Screw System and JAZZ CAP SP | Implanet, S.A. | 2019 | — |
| +1 | K240392 | JAZZ Spinal System | Implanet | 2024 | — |
| +1 | K160226 | JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector | Implanet, S.A. | 2016 | — |
| +2 | K252437 | JAZZ Spinal System | Implanet | 2025 | — |
| +2 | K230565 | HILINE™ Fixation System | Globus Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 10 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 13 | 0 |
| 2004 | 17 | 0 |
| 2005 | 14 | 0 |
| 2006 | 10 | 0 |
| 2007 | 7 | 0 |
| 2008 | 10 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K120564 | Calypso SystemSummary page 4…– Spinal Pedicle Fixation Orthosis - NKB, OSH, MNI, MNH 888.3050 – Spinal Interlaminal Fixation Orthosis - KWP Predicate Devices IMPLANET Spine System (K120564; K132303 (Primary Predicate)) Purpose of the 510(k) Notice The IMPLANET Spine System (ISS) is a modification to the clea… | 2012 |
| * | K132303 | Implanet Spine SystemSummary page 4…Pedicle Fixation Orthosis - NKB, OSH, MNI, MNH 888.3050 – Spinal Interlaminal Fixation Orthosis - KWP Predicate Devices IMPLANET Spine System (K120564; K132303 (Primary Predicate)) Purpose of the 510(k) Notice The IMPLANET Spine System (ISS) is a modification to the cleared IMPLA… | 2013 |
What descends from it? (8)
3 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?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 19 of the 145 ancestors have a recall of any class.
- Of its descendants, K182771 (Implanet, S.A., 2019) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K120564.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 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 lordlosis), 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.
https://510kreport.com/device/K143731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143731: IMPLANET Spine System (ISS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143731
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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