510(k) · Cleared
ClearedColorado 2 Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jul 22, 2002 after a 179-day review. The FDA summary names no predicate by number. 11 later devices descend from it.
- Decided
- Jul 22, 2002
- Review
- 179 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK020247 Colorado 2 Spinal SystemMedtronic Sofamor Danek, Inc. · 2002
- Descendant · cites it directly · 10 of its ownK201659 KHEIRON® Spinal Fixation SystemS.M.A.I.O · 2020
- Descendant · 2 generations on · 8 of its ownK211981 KHEIRON® Spinal Fixation SystemS.M.A.I.O · 2022
- Descendant · 3 generations on · 6 of its ownK232650 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023
- Descendant · 3 generations on · 4 of its ownK251804 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
- Descendant · 3 generations on · 2 of its ownK253990 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K201659KHEIRON® Spinal Fixation SystemS.M.A.I.O · 2020 · cites it directly10descendants
- K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O · 2022 · 2 generations on8descendants
- K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023 · 3 generations on6descendants
- K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025 · 3 generations on4descendants
- K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020247 | Colorado 2 Spinal System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| +1 | K201659 | KHEIRON® Spinal Fixation System | S.M.A.I.O | 2020 | — |
| +2 | K211981 | KHEIRON® Spinal Fixation System | S.M.A.I.O | 2022 | — |
| +3 | K232650 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2023 | — |
| +3 | K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025 | — |
| +3 | K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (11)
See all 112 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?
- Of its descendants, K201659 (S.M.A.I.O, 2020) has gone furthest, with 10 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADO 2TM Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation…
Read the full statement (275 words)
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADO 2TM Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the COLORADO 2TM Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the COLORADO 2TM Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
When used as an anterolateral thoracic/lumbar system, the COLORADO 2TM Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020247: Colorado 2 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/K020247
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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