510(k) · Cleared
ClearedGemmed pedicle screw spinal system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Gemmed Medical Instrument Co., Ltd. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Sep 24, 2015 as substantially equivalent to K140053 (Suzhou Kangli Orthopaedics Instrument Co., Ltd., 2014) after a 104-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Sep 24, 2015
- Review
- 104 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K031655 (2003). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK031655 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2003 · Recalled
- 3 generations backK042790 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 2 generations backK122994 Intramedullary Nail SystemWeigao Orthopaedic Device Co., Ltd. · 2013
- 1 generation backK140053 Kangli Pedicle Screw Spinal SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014
- This deviceK151592 Gemmed pedicle screw spinal systemSuzhou Gemmed Medical Instrument Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K031655 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2003 | 1 |
| −3 | K042790 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −2 | K122994 | Intramedullary Nail System | Weigao Orthopaedic Device Co., Ltd. | 2013 | — |
| −1 | K140053 | Kangli Pedicle Screw Spinal System | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 2014 | — |
| 0 (this device) | K151592 | Gemmed pedicle screw spinal system | Suzhou Gemmed Medical Instrument Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K140053 | Kangli Pedicle Screw Spinal SystemSummary page 4…evice Class: Class II Classification Panel: Orthopedic Panel Product Code: MNI, MNH Regulation Number: 21 CFR part 888.3070 4. Primary Predicate Device 510 (k) Number: K140053 Product Name: Kangli® pedicle screw spinal system Submitter: Suzhou Kangli Orthopaedics Instrument Co., Ltd., 5. Device Descrip… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K140053.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Gemmed® pedicle screw spinal system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-SI 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. The levels of fixation are T8 — S1.
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/K151592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151592: Gemmed pedicle screw spinal system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151592
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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