510(k) · Cleared
ClearedMini-OSTEO Pedicle Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed Indústria E Comércio DE Implantes Ltda · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Nov 21, 2023 as substantially equivalent to K162494 (Medtronic Sofamor Danek USA, Inc., 2016) and 4 other predicates after a 187-day review. Its family tree reaches back 20 generations to 2004. 1 of the 542 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 21, 2023
- Review
- 187 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 20 generations to K040583 (2004). 541 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 542 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 backK190636 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2019
- This deviceK231443 Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023
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 backK190636 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2019
- This deviceK231443 Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023
Class I recalls in this family
- K100952 Modification to Synthes Matrix System5 generations back · 2010
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 | K190636 | NuVasive® Reline® 4.5-5.0 System | Nu Vasive, Incorporated | 2019 | — |
| 0 (this device) | K231443 | Mini-OSTEO Pedicle Fixation System | Osteomed Indústria E Comércio DE Implantes Ltda | 2023 | — |
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 | 7 | 0 |
| 1995 | 17 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 21 | 0 |
| 1999 | 18 | 0 |
| 2000 | 29 | 0 |
| 2001 | 36 | 0 |
| 2002 | 28 | 0 |
| 2003 | 29 | 0 |
| 2004 | 41 | 0 |
| 2005 | 33 | 0 |
| 2006 | 31 | 0 |
| 2007 | 23 | 0 |
| 2008 | 26 | 0 |
| 2009 | 22 | 0 |
| 2010 | 30 | 1 |
| 2011 | 20 | 0 |
| 2012 | 12 | 0 |
| 2013 | 15 | 0 |
| 2014 | 8 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (5)
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 |
|---|---|---|---|
| * | K162494 | CD HORIZON® Spinal SystemSummary page 4…m, Class II Product Codes: NKB, KWP Device Panel: Orthopedic CFR section: 21 CFR 888.3070 21 CFR 888.3050 Predicate K162494 - CD Horizon® Spinal System, Mecatronic, Inc. Devices: K122226 - Revere® Stabilization System, Globus Medical, Inc.… | 2016 |
| * | K122226 | Revere Stabilization SystemSummary page 4…FR section: 21 CFR 888.3070 21 CFR 888.3050 Predicate K162494 - CD Horizon® Spinal System, Mecatronic, Inc. Devices: K122226 - Revere® Stabilization System, Globus Medical, Inc. K190636 - Reline 4.5-5.0 System, NuVasive Submitter:… | 2012 |
| * | K190636 | NuVasive® Reline® 4.5-5.0 SystemSummary page 4…e K162494 - CD Horizon® Spinal System, Mecatronic, Inc. Devices: K122226 - Revere® Stabilization System, Globus Medical, Inc. K190636 - Reline 4.5-5.0 System, NuVasive Submitter: Fernando Argenton Neto (Responsible Engineer) regulat… | 2019 |
| * | K222229 | Advanced LumFix Spinal Fixation System Cleared while this submission was under review Summary page 4…Code Type Advanced LumFix Spinal Fixation CG Bio Co., Primary K222229 NKB System Ltd.… | 2023 |
| * | K223096 | Dark Star Deformity Pedicle Screw System Cleared while this submission was under review Summary page 4…NKB System Ltd. Dark Star Deformity Pedicle Screw Republic NKB, Additional K223096 System Spine, LLC KWP… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 7 months on median.
- 68 of the 541 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K162494.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Mini-OSTEO Pedicle Fixation System is intended for posterior, non-cervical pedicle fixation of the spine 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/or sacral spine: degenerative disc disease (DDD) 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; pseudoarthrosis; and/or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231443: Mini-OSTEO Pedicle Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231443
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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