510(k) · Cleared
ClearedMomentum™ Posterior Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulrich Medical USA · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 2, 2019 as substantially equivalent to K123717 (Ulrich GmbH & Co. KG, 2013) and 4 other predicates after a 75-day review. Its family tree reaches back 16 generations to 1985. 1 of the 405 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Oct 2, 2019
- Review
- 75 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K853033 (1985). 402 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 2 citing it directly. 1 of the 405 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations between
- 3 generations backK120696 Tiger Spine SystemCorelink, LLC · 2012
- 2 generations backK131250 Tiger Spine SystemCorelink, LLC · 2013
- 1 generation backK133369 Tiger Spine SystemCorelink, LLC · 2014
- This deviceK191932 Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019
- Descendant · cites it directly · 1 of its ownK231809 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 16 generations
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 14 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 13 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 12 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 11 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 10 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 9 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 8 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 7 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 5 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 4 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 3 generations backK120696 Tiger Spine SystemCorelink, LLC · 2012
- 2 generations backK131250 Tiger Spine SystemCorelink, LLC · 2013
- 1 generation backK133369 Tiger Spine SystemCorelink, LLC · 2014
- This deviceK191932 Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019
Class I recalls in this family
- K100952 Modification to Synthes Matrix System3 generations back · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −15 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −14 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −13 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −12 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −11 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −10 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −9 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −8 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −7 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −5 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −4 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −3 | K120696 | Tiger Spine System | Corelink, LLC | 2012 | — |
| −2 | K131250 | Tiger Spine System | Corelink, LLC | 2013 | — |
| −1 | K133369 | Tiger Spine System | Corelink, LLC | 2014 | — |
| 0 (this device) | K191932 | Momentum™ Posterior Spinal Fixation System | Ulrich Medical USA | 2019 | — |
| +1 | 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 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 10 | 0 |
| 1997 | 10 | 0 |
| 1998 | 15 | 0 |
| 1999 | 19 | 0 |
| 2000 | 26 | 0 |
| 2001 | 27 | 0 |
| 2002 | 29 | 0 |
| 2003 | 27 | 0 |
| 2004 | 46 | 0 |
| 2005 | 32 | 0 |
| 2006 | 24 | 0 |
| 2007 | 19 | 0 |
| 2008 | 18 | 0 |
| 2009 | 17 | 0 |
| 2010 | 18 | 1 |
| 2011 | 13 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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.
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 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? (5)
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 |
|---|---|---|---|
| * | K123717 | UcentumSummary page 4…(ASTM F136) and Cobalt Chrome (ASTM F1537). Primary Predicate: uCentum™ comprehensive posterior system (ulrich GmbH & Co. KG. – K123717) ® Additional Predicates: Tiger Spine System (CoreLink LLC – K133369) , flamenco™ Spinal Fixatio… | 2013 |
| * | K133369 | Tiger Spine SystemSummary page 4…posterior system (ulrich GmbH & Co. KG. – K123717) ® Additional Predicates: Tiger Spine System (CoreLink LLC – K133369) , flamenco™ Spinal Fixation 3®… | 2014 |
| * | K102853 | Flamenco Spinal Fixation SystemSummary page 4…– K133369) , flamenco™ Spinal Fixation 3® System (ulrich GmbH & Co. KG– K102853), neon universal OCT spinal ®… | 2011 |
| * | K161032 | neon3™ universal OCT spinal stabilizationSummary page 4…nal ® stabilization clearance (ulrich GmbH & Co. KG – K161032), Diplomat Spinal System (SIGNUS Medizintechnik GmbH – K151704)… | 2016 |
| * | K151704 | Diplomat® Spinal SystemSummary page 4…® stabilization clearance (ulrich GmbH & Co. KG – K161032), Diplomat Spinal System (SIGNUS Medizintechnik GmbH – K151704) K191932 Page 2 of 2 Performance Data… | 2016 |
What descends from it? (2)
2 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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 49 of the 402 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K231809 (Ulrich Medical USA, 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K123717.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 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 (116 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.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191932 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191932: Momentum™ Posterior Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191932
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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