510(k) · Cleared
ClearedIntramedullary Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weigao Orthopaedic Device Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Apr 12, 2013 as substantially equivalent to K042790 (Medtronic Sofamor Danek, 2004) after a 197-day review. Its family tree reaches back 2 generations to 2003. 7 later devices descend from it.
- Decided
- Apr 12, 2013
- Review
- 197 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K031655 (2003). 3 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK031655 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2003 · Recalled
- 1 generation backK042790 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- This deviceK122994 Intramedullary Nail SystemWeigao Orthopaedic Device Co., Ltd. · 2013
- Descendant · cites it directly · 3 of its ownK140053 Kangli Pedicle Screw Spinal SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK143013 Spinal Inner Fixation SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK222031 Spinal Inner Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK152324 YAHUA Spinal SystemBeijing Weigao Yahua Artificial Joint Development Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK151592 Gemmed pedicle screw spinal systemSuzhou Gemmed Medical Instrument Co., Ltd. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K140053Kangli Pedicle Screw Spinal SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014 · cites it directly3descendants
- K143013Spinal Inner Fixation SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015 · cites it directly1descendant
- K222031Spinal Inner Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd. · 2022 · 2 generations on0descendants
- K152324YAHUA Spinal SystemBeijing Weigao Yahua Artificial Joint Development Co., Ltd. · 2016 · cites it directly0descendants
- K151592Gemmed pedicle screw spinal systemSuzhou Gemmed Medical Instrument Co., Ltd. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031655 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2003 | 1 |
| −1 | K042790 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| 0 (this device) | K122994 | Intramedullary Nail System | Weigao Orthopaedic Device Co., Ltd. | 2013 | — |
| +1 | K140053 | Kangli Pedicle Screw Spinal System | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 2014 | — |
| +1 | K143013 | Spinal Inner Fixation System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015 | — |
| +2 | K222031 | Spinal Inner Fixation System | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | 2022 | — |
| +1 | K152324 | YAHUA Spinal System | Beijing Weigao Yahua Artificial Joint Development Co., Ltd. | 2016 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2022 | 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 MNH? 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 |
|---|---|---|---|
| * | K042790 | CD Horizon Spinal SystemSummary page 2…immobilization of the spine as an adjunct to fusion with bone graft. "The levels of fixation are T8 - SI. 5. Predicate Device Identification 510(k) Number: K042790 Product Name: CD HORIZON & Spinal System Predicate Device Name: CD HORIZON LEGACY 5.5mm Spinal System Manufacturer… | 2004 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K140053 (Suzhou Kangli Orthopaedics Instrument Co., Ltd., 2014) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K042790.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The General Spinal System 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. The levels of fixation are T8 - S1
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122994: Intramedullary Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122994
Report an extraction error
Are you the manufacturer?
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