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. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Apr 1, 2016 as substantially equivalent to K113666 (Stryker Spine, 2012) after a 56-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.
- Decided
- Apr 1, 2016
- Review
- 56 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K950697 (1995). 45 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 6 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 5 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 4 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 3 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 2 generations backK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · Recalled
- 1 generation backK113666 Xia 3 Spinal SystemStryker Spine · 2012
- This deviceK160320 PremierShandong Weigao Orthopaedic Device Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK170861 PremierShandong Weigao Orthopaedic Device Co., Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K170861PremierShandong Weigao Orthopaedic Device Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −6 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −5 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −4 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −3 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −2 | K071373 | Stryker Spine Xia Iii Spinal System | Stryker Spine | 2007 | 1 |
| −1 | K113666 | Xia 3 Spinal System | Stryker Spine | 2012 | — |
| 0 (this device) | K160320 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | 2016 | — |
| +1 | 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 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K113666 | Xia 3 Spinal SystemSummary page 6…irements for the development, validation, and routine control of a sterilization process for medical devices. Identification of Primary Predicate Device 510(k) Number: K113666 Product Name: XIA®3 Spinal System Non-Clinical Test Conclusion Non clinical tests and engineering rationales were conducted to… | 2012 |
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 |
|---|---|---|---|
| K170861 | Premier | 2017 | 0 |
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 21 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 45 ancestors have a recall of any class.
- Of its descendants, K170861 (Shandong Weigao Orthopaedic Device Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 20 other devices also cite its predicate K113666.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Premier is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis
(grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis,
kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally
mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft.
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/K160320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160320: Premier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160320
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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