510(k) · Cleared
Recalled · Class II · 2026Vector™ Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on May 20, 2024 as substantially equivalent to K102248 (Innovasis, Inc., 2010) and 2 other predicates after a 14-day review. Its family tree reaches back 18 generations to 2004. 1 of the 352 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- May 20, 2024
- Review
- 14 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 18 generations to K040583 (2004). 350 ancestors in all, the oldest K841189 (1984). 1 later device descends from it, 1 citing it directly. 1 of the 352 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations between
- 3 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 2 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 1 generation backK161014 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- This deviceK241276 Vector™ Pedicle Screw SystemInnovasis, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK251073 Innovasis Navigation Instruments (Vector G-E Navigation Instruments…Innovasis, Inc. · 2025 · Recalled
Show all 18 generations
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 6 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 5 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 4 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 3 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 2 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 1 generation backK161014 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- This deviceK241276 Vector™ Pedicle Screw SystemInnovasis, Inc. · 2024
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
Most influential descendants
Showing 1 of 1 · See all- K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −15 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −13 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −10 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −9 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −8 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −7 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −6 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −5 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −4 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −3 | K141604 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −2 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| −1 | K161014 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| 0 (this device) | K241276 | Vector™ Pedicle Screw System | Innovasis, Inc. | 2024 | — |
| +1 | K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the… | Innovasis, Inc. | 2025 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 8 | 0 |
| 1997 | 11 | 0 |
| 1998 | 17 | 0 |
| 1999 | 14 | 0 |
| 2000 | 25 | 0 |
| 2001 | 26 | 0 |
| 2002 | 18 | 0 |
| 2003 | 21 | 0 |
| 2004 | 33 | 0 |
| 2005 | 25 | 0 |
| 2006 | 16 | 0 |
| 2007 | 14 | 0 |
| 2008 | 15 | 0 |
| 2009 | 10 | 0 |
| 2010 | 11 | 1 |
| 2011 | 7 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (3)
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 |
|---|---|---|---|
| * | K102248 | Excella II Spinal System Model EC2-00Summary page 4…0 Product Code(s) NKB, KWP 21 CFR 807.92(a)(3) | Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K102248 Excella lI® Spinal System NKB K140238 Excella lllI-D® Spinal Deformity System NKB K161014 Nuvasive® Reline® System NKB Device De… | 2010 |
| * | K140238 | Excella Iii-D Spinal Deformity SystemSummary page 4…7.92(a)(3) | Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K102248 Excella lI® Spinal System NKB K140238 Excella lllI-D® Spinal Deformity System NKB K161014 Nuvasive® Reline® System NKB Device Description Summary 21 CFR 807.92(a)(4)… | 2014 |
| * | K161014 | NuVasive® Reline® SystemSummary page 4…edicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K102248 Excella lI® Spinal System NKB K140238 Excella lllI-D® Spinal Deformity System NKB K161014 Nuvasive® Reline® System NKB Device Description Summary 21 CFR 807.92(a)(4) The Vector™ Pedicle Screw System is a thoracolumbar… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E… | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2026 | Class II | Z-2859-2026 | Process design | Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from… |
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 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 6 months on median.
- 39 of the 350 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K251073 (Innovasis, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K102248.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
When used for posterior pedicle screw or posterior non-pedicle fixation, the Innovasis Vector™ Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (DDD — defined as discogenic back pain with degeneration of the…
Read the full statement (169 words)
When used for posterior pedicle screw or posterior non-pedicle fixation, the Innovasis Vector™ Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (DDD — defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture, dislocation, failed previous fusion (pseudoarthrosis), and/or tumor resection.
When used for posterior non-cervical screw fixation in pediatric patients, the Innovasis Vector Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis (AlS). Additionally, the Innovasis Vector Pedicle Screw System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241276: Vector™ Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241276
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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