510(k) · Cleared
Recalled · Class II · 2022LineSider™ Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrity Implants, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 3, 2020 as substantially equivalent to K190360 (Integrity Implants, Inc., 2019) and 1 other predicate after a 17-day review. Its family tree reaches back 20 generations to 2004. 1 of the 372 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 3, 2020
- Review
- 17 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 20 generations to K040583 (2004). 366 ancestors in all, the oldest K781443 (1978). 5 later devices descend from it, 2 citing it directly. 1 of the 372 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations between
- 3 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- 2 generations backK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017
- 1 generation backK190360 LineSider™ Spinal SystemIntegrity Implants, Inc. · 2019
- This deviceK203367 LineSider™ Spinal SystemIntegrity Implants, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK231098 LineSider® Spinal SystemIntegrity Implants, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK232413 Fusion Robotic Navigation SystemAlphatec Spine, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal…Alphatec Spine, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK212088 Integrity Implants Navigated InstrumentsIntegrity Implants, Inc. · 2021
Show all 20 generations
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 17 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 15 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 13 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 12 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 11 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 10 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 9 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 8 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 7 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 6 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 5 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 4 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 3 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- 2 generations backK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017
- 1 generation backK190360 LineSider™ Spinal SystemIntegrity Implants, Inc. · 2019
- This deviceK203367 LineSider™ Spinal SystemIntegrity Implants, Inc. · 2020
Class I recalls in this family
- K100952 Modification to Synthes Matrix System3 generations back · 2010
Most influential descendants
Showing 5 of 5 · See all- K231098LineSider® Spinal SystemIntegrity Implants, Inc. · 2023 · cites it directly3descendants
- K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc. · 2023 · 2 generations on2descendants
- K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 3 generations on1descendant
- K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026 · 4 generations on0descendants
- K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −17 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −15 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −13 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −12 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −11 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −10 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −9 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −8 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −7 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −6 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −5 | K141604 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −4 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| −3 | K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| −2 | K170126 | NuVasive® Reline® 4.5-5.0 System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K190360 | LineSider™ Spinal System | Integrity Implants, Inc. | 2019 | — |
| 0 (this device) | K203367 | LineSider™ Spinal System | Integrity Implants, Inc. | 2020 | — |
| +1 | K231098 | LineSider® Spinal System | Integrity Implants, Inc. | 2023 | — |
| +2 | K232413 | Fusion Robotic Navigation System | Alphatec Spine, Inc. | 2023 | — |
| +3 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | Alphatec Spine, Inc. | 2026 | — |
| +4 | K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation… | Alphatec Spine, Inc. | 2026 | — |
| +1 | K212088 | Integrity Implants Navigated Instruments | Integrity Implants, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 6 | 0 |
| 1995 | 15 | 0 |
| 1996 | 9 | 0 |
| 1997 | 11 | 0 |
| 1998 | 17 | 0 |
| 1999 | 16 | 0 |
| 2000 | 24 | 0 |
| 2001 | 26 | 0 |
| 2002 | 16 | 0 |
| 2003 | 23 | 0 |
| 2004 | 34 | 0 |
| 2005 | 25 | 0 |
| 2006 | 18 | 0 |
| 2007 | 16 | 0 |
| 2008 | 16 | 0 |
| 2009 | 10 | 0 |
| 2010 | 10 | 1 |
| 2011 | 8 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 7 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 2 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K190360 | LineSider™ Spinal SystemSummary page 4…d sizes to meet the requirements of the individual patient anatomy. The LineSider™ Spinal System subject to this 510(k) adds non-modular screws to the line offered under K190360. The purpose of this submission is to expand the LineSider™ Spinal System to include non- modular screws to the line of previous… | 2019 |
| * | K171170 | M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsSummary page 5…rity Implants Primary Inc. K171170 M.U.S.T. Pedicle Screw System Medacta… | 2017 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 3, 2022 | Class II | Z-0421-2023 | Under Investigation by firm | Potential for intraoperative screw head separation at weld location. |
| Jan 27, 2022 | Class II | Z-0420-2023 | Device Design | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank. |
| Jan 27, 2022 | Class II | Z-0418-2023 | Device Design | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank. |
| Jan 27, 2022 | Class II | Z-0419-2023 | Device Design | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 7 months on median.
- 43 of the 366 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K231098 (Integrity Implants, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K190360.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
LineSider™ Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion 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; curvatures (i.e., scoliosis, kyphosis…
Read the full statement (152 words)
LineSider™ Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion 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; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, LineSider™ Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, LineSider™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis; fracture caused by tumor and/or trauma. LineSider™ Spinal System is intended 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/K203367 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203367: LineSider™ Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203367
Report an extraction error
Are you the manufacturer?
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