510(k) · Cleared
ClearedNatural Bridge LP Transverse Connectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jan 3, 2008 as substantially equivalent to K052398 (K2m, LLC, 2005) and 3 other predicates after an 83-day review. Its family tree reaches back 1 generation to 2005. 65 later devices descend from it.
- Decided
- Jan 3, 2008
- Review
- 83 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K042635 (2005). 4 ancestors in all. 65 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK042635 Denali Spine SystemK2m, LLC · 2005
- This deviceK072914 Natural Bridge LP Transverse ConnectorsK2m, Inc. · 2008
- Descendant · cites it directly · 53 of its ownK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- Descendant · cites it directly · 43 of its ownK120656 Everest Spinal SystemK2m, Inc. · 2012
- Descendant · cites it directly · 41 of its ownK132757 Everest Spinal SystemK2m, Inc. · 2013
- Descendant · cites it directly · 38 of its ownK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- Descendant · 2 generations on · 36 of its ownK130330 Range Spinal SystemK2m, Inc. · 2013
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K120099Range Spinal System (Mesa and Denali)K2m, Inc. · 2012 · cites it directly53descendants
- K120656Everest Spinal SystemK2m, Inc. · 2012 · cites it directly43descendants
- K132757Everest Spinal SystemK2m, Inc. · 2013 · cites it directly41descendants
- K121016Range Spinal System (Mesa and Denali)K2m, Inc. · 2012 · cites it directly38descendants
- K130330Range Spinal SystemK2m, Inc. · 2013 · 2 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042635 | Denali Spine System | K2m, LLC | 2005 | — |
| 0 (this device) | K072914 | Natural Bridge LP Transverse Connectors | K2m, Inc. | 2008 | — |
| +1 | K120099 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| +1 | K120656 | Everest Spinal System | K2m, Inc. | 2012 | — |
| +1 | K132757 | Everest Spinal System | K2m, Inc. | 2013 | — |
| +1 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| +2 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 8 | 0 |
| 2016 | 4 | 0 |
| 2017 | 7 | 0 |
| 2018 | 7 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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? (4)
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 |
|---|---|---|---|
| * | K052398 | Mesa Spinal SystemSummary page 1…ion Orthosis (21 CFR 888.3050) 3. Predicate or legally marketed devices which are substantially equivalent * K2M Natural Bridge Transverse Connectors (510(k) K052398, K042635, K052404, K052405) 4. Description of the device: The Natural Bridge LP Transverse Connectors are devices inten… | 2005 |
| * | K042635 | Denali Spine SystemSummary page 1…sis (21 CFR 888.3050) 3. Predicate or legally marketed devices which are substantially equivalent * K2M Natural Bridge Transverse Connectors (510(k) K052398, K042635, K052404, K052405) 4. Description of the device: The Natural Bridge LP Transverse Connectors are devices intended to be… | 2005 |
| * | K052404 | Denali Deformity SystemSummary page 1…FR 888.3050) 3. Predicate or legally marketed devices which are substantially equivalent * K2M Natural Bridge Transverse Connectors (510(k) K052398, K042635, K052404, K052405) 4. Description of the device: The Natural Bridge LP Transverse Connectors are devices intended to be used in… | 2006 |
| * | K052405 | Sterling Interferenc Screw HTSummary page 1…50) 3. Predicate or legally marketed devices which are substantially equivalent * K2M Natural Bridge Transverse Connectors (510(k) K052398, K042635, K052404, K052405) 4. Description of the device: The Natural Bridge LP Transverse Connectors are devices intended to be used in conjuncti… | 2005 |
What descends from it? (65)
See all 657 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120099 | Range Spinal System (Mesa and Denali) | 2012 | 53 |
| K120656 | Everest Spinal System | 2012 | 43 |
| K132757 | Everest Spinal System | 2013 | 41 |
| K121016 | Range Spinal System (Mesa and Denali) | 2012 | 38 |
| K120899 | Range Spinal System, Unit Rod | 2012 | 35 |
| K131030 | Range Spinal System | 2013 | 34 |
| K140529 | Everest Spinal System | 2014 | 31 |
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?
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Range Spinal System is a non-cervical spinal fixation devices intended for posterior, non-pedicle fixation for the following indications: 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…
Read the full statement (160 words)
The Range Spinal System is a non-cervical spinal fixation devices intended for posterior, non-pedicle fixation for the following indications: 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 failed previous fusion.
The Range Spinal System is also intended for non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. They are also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072914 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072914: Natural Bridge LP Transverse Connectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072914
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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