510(k) · Cleared
ClearedMomentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulrich Medical USA · PML Bone Cement, Posterior Screw Augmentation
Cleared on Oct 20, 2023 as substantially equivalent to K200596 (Icotec AG, 2020) and 3 other predicates after a 122-day review. Its family tree reaches back 22 generations to 2004. 1 of the 559 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Oct 20, 2023
- Review
- 122 days
- Class
- Class II
- Product code
- PML
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 22 generations to K040583 (2004). 557 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 1 of the 559 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations between
- 3 generations backK202458 BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH · 2021
- 2 generations backK212489 BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA · 2021
- 1 generation backK222256 BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA · 2022
- This deviceK231809 Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone…Ulrich Medical USA · 2023
- Descendant · cites it directly · 0 of its ownK251719 Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025
Show all 22 generations
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 21 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 20 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 19 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 18 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 17 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 15 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 14 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 13 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 12 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 11 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 10 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 9 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 8 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 7 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 6 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 5 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
- 4 generations backK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
- 3 generations backK202458 BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH · 2021
- 2 generations backK212489 BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA · 2021
- 1 generation backK222256 BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA · 2022
- This deviceK231809 Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone…Ulrich Medical USA · 2023
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
Most influential descendants
Showing 1 of 1 · See all- K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −21 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −20 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −19 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −18 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −17 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −15 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −14 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −13 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −12 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −11 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −10 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −9 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −8 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −7 | K143019 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −6 | K153463 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −5 | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the… | Medtronic Sofamor Danek | 2017 | — |
| −4 | K191148 | Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −3 | K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | Osartis GmbH | 2021 | — |
| −2 | K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | Neo Medical SA | 2021 | — |
| −1 | K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System™ | Neo Medical SA | 2022 | — |
| 0 (this device) | K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement… | Ulrich Medical USA | 2023 | — |
| +1 | K251719 | Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 3 | 0 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 16 | 0 |
| 1996 | 12 | 0 |
| 1997 | 16 | 0 |
| 1998 | 22 | 0 |
| 1999 | 22 | 0 |
| 2000 | 32 | 0 |
| 2001 | 32 | 0 |
| 2002 | 33 | 0 |
| 2003 | 33 | 0 |
| 2004 | 51 | 0 |
| 2005 | 37 | 0 |
| 2006 | 30 | 0 |
| 2007 | 24 | 0 |
| 2008 | 23 | 0 |
| 2009 | 20 | 0 |
| 2010 | 22 | 1 |
| 2011 | 17 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 9 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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.
Top candidate predicates for a new PML device
- #1 K200596 G21 Cement, VADER® Pedicle Systemscore 24.9 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K200596 | G21 Cement, VADER® Pedicle SystemSummary page 6…e Cement Class: II Product Codes: PML, NKB Primary Predicates: G21 Cement, VADER® Pedicle System, icotec ag, K200596 Additional Predicates: Additional Predicate: Momentum® Posterior Spinal Fixation System (K191932)… | 2020 |
| * | K191932 | Momentum™ Posterior Spinal Fixation SystemSummary page 6…G21 Cement, VADER® Pedicle System, icotec ag, K200596 Additional Predicates: Additional Predicate: Momentum® Posterior Spinal Fixation System (K191932) Additional Predicate: Momentum® MIS Posterior Spinal Fixation System (K223274… | 2019 |
| * | K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System™Summary page 6…Fixation System (K223274) Additional Predicate: BonOs® Inject Bone Cement; NEO Pedicle Screw System™, Neo Medical SA, K222256 K231809… | 2022 |
| * | K223274 | Momentum® MIS Posterior Spinal Fixation SystemSummary page 6…xation System (K191932) Additional Predicate: Momentum® MIS Posterior Spinal Fixation System (K223274) Additional Predicate: BonOs® Inject Bone Cement; NEO Pedicle Screw System™, N… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251719 | Momentum® Posterior Spinal Fixation System | 2025 | 0 |
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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 73 of the 557 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K251719 (Ulrich Medical USA, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K200596.
How does its category compare?
All PML devicesPML Bone Cement, Posterior Screw Augmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PML
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PML
116in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PML
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PML
55in 2025
MAUDE reports naming product code PML, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 35 |
| 2020 | 3 | 182 | 0 | 27 |
| 2021 | 1 | — | 0 | 32 |
| 2022 | 2 | — | 0 | 12 |
| 2023 | 3 | 116 | 2 | 18 |
| 2024 | 1 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 55 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Momentum® Posterior Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/ or lordosis), trauma (i.e.…
Read the full statement (394 words)
The Momentum® Posterior Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.
When used in conjunction with G21 V-Steady Bone Cement, the Momentum Posterior Spinal Fixation System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.
In order to achieve additional levels of fixation, the Momentum Posterior Spinal Fixation System can also be connected to the neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the neon3 Instructions for Use for a list of indications for use.
The Momentum® MIS Posterior Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum MIS is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.
When used in conjunction with G21 V-Steady Bone Cement, the Momentum MIS Posterior Spinal Fixation System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum MIS Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231809 · printed Nov 4, 2026
Cite this page
510(k) Report. “K231809: Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K231809
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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