510(k) · Cleared
ClearedExpedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Sep 28, 2005 as substantially equivalent to K033901 (Depuy Spine, Inc., 2004) and 3 other predicates after a 54-day review. Its family tree reaches back 4 generations to 1995. 1 of the 510 devices in its family, counting itself, has a Class I recall. 495 later devices descend from it.
- Decided
- Sep 28, 2005
- Review
- 54 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K944736 (1995). 14 ancestors in all. 495 later devices descend from it, 2 citing it directly. 1 of the 510 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK944736 VSP (Variable Screw Placement)Acromed Corp. · 1995
- 3 generations backK981274 Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
- 2 generations backK010576 Monarch Spine SystemDepuyacromed · 2001
- 1 generation backK021148 Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed · 2002
- This deviceK052131 Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005
- Descendant · cites it directly · 490 of its ownK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- Descendant · 2 generations on · 424 of its ownK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- Descendant · 2 generations on · 398 of its ownK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- Descendant · 2 generations on · 397 of its ownK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- Descendant · 2 generations on · 264 of its ownK063772 Expedium Spine SystemDepuy Spine, Inc. · 2007
Showing 5 of 495 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 495 · See all- K062174Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · cites it directly490descendants
- K063156Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 2 generations on424descendants
- K063741Expedium Spine SystemDepuy Spine, Inc. · 2007 · 2 generations on398descendants
- K080313Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008 · 2 generations on397descendants
- K063772Expedium Spine SystemDepuy Spine, Inc. · 2007 · 2 generations on264descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944736 | VSP (Variable Screw Placement) | Acromed Corp. | 1995 | — |
| −3 | K981274 | Acromed Timx Plate Based Low Back System | Acromed Corp. | 1998 | — |
| −2 | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| −1 | K021148 | Monarch Spine System Commercially Pure Titanium Spinal Rod | Depuyacromed | 2002 | — |
| 0 (this device) | K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods | Depuy Spine, Inc. | 2005 | — |
| +1 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| +2 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| +2 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| +2 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| +2 | K063772 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 16 | 0 |
| 2013 | 20 | 0 |
| 2014 | 19 | 0 |
| 2015 | 24 | 0 |
| 2016 | 20 | 0 |
| 2017 | 27 | 0 |
| 2018 | 33 | 0 |
| 2019 | 28 | 0 |
| 2020 | 30 | 0 |
| 2021 | 26 | 1 |
| 2022 | 35 | 0 |
| 2023 | 52 | 0 |
| 2024 | 52 | 0 |
| 2025 | 47 | 0 |
| 2026 | 41 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K033901 | Merlin Spine SystemSummary page 1…ystem 5.5mm Commercially Pure Titanium Spinal Rods PREDICATE DEVICES: EXPEDIUM TM Spine System (Merlin Spine System) - K033901 MOSS MIAMI TM Spinal System - K955348 MONARCH TM Spine System - K024348, K021 148… | 2004 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 1…Spinal Rods PREDICATE DEVICES: EXPEDIUM TM Spine System (Merlin Spine System) - K033901 MOSS MIAMI TM Spinal System - K955348 MONARCH TM Spine System - K024348, K021 148 DEVICE DESCRIPTION: The EXPEDIUM' TM Spine System Commerci… | 1996 |
| * | K024348 | Monarch Spine SystemSummary page 1…stem (Merlin Spine System) - K033901 MOSS MIAMI TM Spinal System - K955348 MONARCH TM Spine System - K024348, K021 148 DEVICE DESCRIPTION: The EXPEDIUM' TM Spine System Commercially Pure Titanium Spinal Rods are… | 2003 |
| * | K021148 | Monarch Spine System Commercially Pure Titanium Spinal RodSummary page 1…lin Spine System) - K033901 MOSS MIAMI TM Spinal System - K955348 MONARCH TM Spine System - K024348, K021 148 DEVICE DESCRIPTION: The EXPEDIUM' TM Spine System Commercially Pure Titanium Spinal Rods are 5.5mm dia… | 2002 |
What descends from it? (495)
See all 4952 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 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 3.1 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K062174 (Depuy Spine, Inc., 2006) has gone furthest, with 490 descendants of its own.
- 34 other devices also cite its predicate K033901.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EXPEDIUM TM 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 lordosis); tumor; pseudoarthrosis; and failed previous…
Read the full statement (571 words)
The EXPEDIUM TM 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 lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The MONARCH TM 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 MONARCH TM Spine System 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 MONARCH TM Spine System 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, lordosis and/or kyphosis) tumor, and previous failed fusion (pseudarthrosis)
The MONARCH Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) Levels of fixation are for the thoracic lumbar and sacral spine
The MONARCH Spine System Dual Rod Connectors can be used to connect MONARCH Spine System Rods to rods of other DePuy Spine 4 75mm, 5.5mm, and 6 35mm diameter rod systems
The EXPEDIUM TM Spine System 5 5ram Commercially Pure Titanium Rods may be used with mating titanium alloy components of the MONARCH TM Spine System which can accept a 5 5 mm diameter rod
The MOSS MIAMITM 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"T' 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 System 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, lordosis and/or kyphosis) tumor, and previous failed fusion (pseudarthrosis).
The EXPEDIUM TM Spine System 5 5nmi Commercially Pure Titanium Rods may be used with mating titanium alloy components of the MOSS MIAMI TM Spine System which can accept a 5 5 mm diameter rod
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052131: Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052131
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