510(k) · Cleared
ClearedPremier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shandong Weigao Orthopaedic Device Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Aug 4, 2017 as substantially equivalent to K160320 (Shandong Weigao Orthopaedic Device Co., Ltd., 2016) and 2 other predicates after a 134-day review. Its family tree reaches back 18 generations to 2001. 1 of the 346 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 4, 2017
- Review
- 134 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K003155 (2001). 345 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 346 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations between
- 3 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- 2 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 1 generation backK150896 Vitality Spinal Fixation SystemZimmer Spine, Inc. · 2015 · Recalled
- This deviceK170861 PremierShandong Weigao Orthopaedic Device Co., Ltd. · 2017
Show all 18 generations
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 17 generations backK012254 VBROsteotech, Inc. · 2001
- 16 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 15 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 13 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 8 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 7 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 6 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 5 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 4 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 3 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- 2 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 1 generation backK150896 Vitality Spinal Fixation SystemZimmer Spine, Inc. · 2015 · Recalled
- This deviceK170861 PremierShandong Weigao Orthopaedic Device Co., Ltd. · 2017
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −17 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −16 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −15 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −13 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −8 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −7 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −6 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −5 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −4 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| −3 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| −2 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| −1 | K150896 | Vitality Spinal Fixation System | Zimmer Spine, Inc. | 2015 | 3 |
| 0 (this device) | K170861 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 7 | 0 |
| 1996 | 6 | 0 |
| 1997 | 8 | 0 |
| 1998 | 12 | 0 |
| 1999 | 10 | 0 |
| 2000 | 21 | 0 |
| 2001 | 25 | 0 |
| 2002 | 17 | 0 |
| 2003 | 19 | 0 |
| 2004 | 36 | 0 |
| 2005 | 33 | 0 |
| 2006 | 24 | 0 |
| 2007 | 15 | 0 |
| 2008 | 22 | 0 |
| 2009 | 20 | 0 |
| 2010 | 18 | 1 |
| 2011 | 12 | 0 |
| 2012 | 5 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K160320 | PremierSummary page 4…racolumbosacral pedicle screw system Class: II Product Codes: NKB.:3 Predicate Device: Weigao Orthopaedic Premier (K160320) Additional Predicate Devices: EXPEDIUM® Spine System (K101070) Vitality® Spi… | 2016 |
| * | K101070 | Expedium Spine SystemSummary page 4…: NKB.:3 Predicate Device: Weigao Orthopaedic Premier (K160320) Additional Predicate Devices: EXPEDIUM® Spine System (K101070) Vitality® Spinal Fixation System (K150896) Indications for Use: The Premier is intended to provid… | 2010 |
| * | K150896 | Vitality Spinal Fixation SystemSummary page 4…ic Premier (K160320) Additional Predicate Devices: EXPEDIUM® Spine System (K101070) Vitality® Spinal Fixation System (K150896) Indications for Use: The Premier is intended to provide immobilization and stabilization of spinal segments in skeletally matur… | 2015 |
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 · 4 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 7 companies; a new generation was cleared every 10 months on median.
- 36 of the 345 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Premier is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1): 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; and failed previous fusion (pseudoarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170861: Premier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170861
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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