510(k) · Cleared
ClearedExpedium Spine System, Moss Miami Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Feb 17, 2011 as substantially equivalent to K033901 (Depuy Spine, Inc., 2004) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1996. 20 later devices descend from it.
- Decided
- Feb 17, 2011
- Review
- 83 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955348 (1996). 2 ancestors in all. 20 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- This deviceK103490 Expedium Spine System, Moss Miami Spine SystemJohnson & Johnson · 2011
- Descendant · cites it directly · 5 of its ownK121786 Dymaxeon Spine SystemB2b Spine Pty, Ltd. · 2012
- Descendant · cites it directly · 4 of its ownK151704 Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016
- Descendant · 2 generations on · 4 of its ownK150184 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2015 · Recalled
- Descendant · 2 generations on · 2 of its ownK191932 Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019
- Descendant · 2 generations on · 2 of its ownK170989 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2017
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd. · 2012 · cites it directly5descendants
- K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016 · cites it directly4descendants
- K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2015 · 2 generations on4descendants
- K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019 · 2 generations on2descendants
- K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| 0 (this device) | K103490 | Expedium Spine System, Moss Miami Spine System | Johnson & Johnson | 2011 | — |
| +1 | K121786 | Dymaxeon Spine System | B2b Spine Pty, Ltd. | 2012 | — |
| +1 | K151704 | Diplomat® Spinal System | Signus Medizintechnik GmbH | 2016 | — |
| +2 | K150184 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | 2015 | 1 |
| +2 | K191932 | Momentum™ Posterior Spinal Fixation System | Ulrich Medical USA | 2019 | — |
| +2 | K170989 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K033901 | Merlin Spine SystemSummary page 1…Product code NKB3, MNI, MNH Classification Class Ill D. Predicate Device Name Trade name: DePuy Spine Expedium® Spine System (K033901) DePuy Spine Moss® Miami Spine System (K955348) E. Device Description The Mo… | 2004 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 1…Class Ill D. Predicate Device Name Trade name: DePuy Spine Expedium® Spine System (K033901) DePuy Spine Moss® Miami Spine System (K955348) E. Device Description The Moss® Miami and Expedium® Spine Systems consists of rods, hooks, pedlicl… | 1996 |
What descends from it? (20)
See all 209 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121786 | Dymaxeon Spine System | 2012 | 5 |
| K151704 | Diplomat® Spinal System | 2016 | 4 |
| K141282 | PGS 5.5 MM Cannulated Pedicle Screw | 2014 | 1 |
| K120091 | R&D Innovation Pedicle Screw System | 2012 | 1 |
| K113396 | Depuy Pulse Thoracolumbar Screw System | 2012 | 1 |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated… | 2019 | 0 |
| K160820 | PressON Pro Spinal Fixation System | 2016 | 0 |
| K143230 | Palladian Lumbar Pedicle Screw System | 2015 | 0 |
| K122229 | Viceroy Spinal System | 2012 | 0 |
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 NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
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 instabilities 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 (338 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 instabilities 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 Systems is also indicated for pedicle screw fixation 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.
The MOSS MIAMI Spine Systems is also a hook and sacral/iliac 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 and/or dislocation), spinal stenosis, deformities (scoliosis, lordlosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The MOSS MIAMI Spine Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordlosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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 lordlosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103490: Expedium Spine System, 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/K103490
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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