510(k) · Cleared
ClearedCrossover Cross Connector (Moss Miami Spine System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuyacromed · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 26, 2002 as substantially equivalent to K013296 (Depuyacromed, 2001) after a 19-day review. Its family tree reaches back 2 generations to 1998. 4 later devices descend from it.
- Decided
- Jun 26, 2002
- Review
- 19 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983583 (1998). 4 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK983583 Depuy Acromed Moss and Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 1 generation backK013296 Moss Miami Spinal SystemsDepuyacromed · 2001
- This deviceK021880 Crossover Cross Connector (Moss Miami Spine System)Depuyacromed · 2002
- Descendant · cites it directly · 0 of its ownK033965 Shiraz-Anterior SystemSpine Next America · 2004
- Descendant · cites it directly · 0 of its ownK033947 Shiraz Posterior SystemSpine Next America · 2004
- Descendant · cites it directly · 0 of its ownK033772 Shiraz-Java Spinal Fixation SystemSpine Next America · 2004
- Descendant · cites it directly · 0 of its ownK031265 Shiraz-Java Spinal Fixation SystemSpine Next SA · 2003
Most influential descendants
Showing 4 of 4 · See all- K033965Shiraz-Anterior SystemSpine Next America · 2004 · cites it directly0descendants
- K033947Shiraz Posterior SystemSpine Next America · 2004 · cites it directly0descendants
- K033772Shiraz-Java Spinal Fixation SystemSpine Next America · 2004 · cites it directly0descendants
- K031265Shiraz-Java Spinal Fixation SystemSpine Next SA · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983583 | Depuy Acromed Moss and Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −1 | K013296 | Moss Miami Spinal Systems | Depuyacromed | 2001 | — |
| 0 (this device) | K021880 | Crossover Cross Connector (Moss Miami Spine System) | Depuyacromed | 2002 | — |
| +1 | K033965 | Shiraz-Anterior System | Spine Next America | 2004 | — |
| +1 | K033947 | Shiraz Posterior System | Spine Next America | 2004 | — |
| +1 | K033772 | Shiraz-Java Spinal Fixation System | Spine Next America | 2004 | — |
| +1 | K031265 | Shiraz-Java Spinal Fixation System | Spine Next SA | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 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 |
|---|---|---|---|
| * | K013296 | Moss Miami Spinal Systems | 2001 |
What descends from it? (4)
4 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 4 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K033965 (Spine Next America, 2004) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K013296.
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?
The Moss Miami Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabiiities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed…
Read the full statement (183 words)
The Moss Miami Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabiiities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Moss Miami Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-SI 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.
The Moss Miami Spine System is also a hook and sacraViliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture andlor dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021880 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021880: Crossover Cross Connector (Moss Miami Spine System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021880
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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