510(k) · Cleared
ClearedMomentum Spine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Momentum Health, Inc. · LDK Device, Sensing, Optical Contour
Cleared on Oct 4, 2023 as substantially equivalent to K923792 (Quantec Image Processing, Ltd., 1994) after an 89-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Oct 4, 2023
- Review
- 89 days
- Class
- Class U
- Product code
- LDK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923792 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK923792 Quantec Spinal Measuement SystemQuantec Image Processing, Ltd. · 1994
- This deviceK232023 Momentum SpineMomentum Health, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923792 | Quantec Spinal Measuement System | Quantec Image Processing, Ltd. | 1994 | — |
| 0 (this device) | K232023 | Momentum Spine | Momentum Health, Inc. | 2023 | — |
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 LDK? 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 LDK device
- #1 K230463 NSite Scoliosis Assessment Appscore 6.3 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K923792 | Quantec Spinal Measuement SystemSummary page 6…Medicine Devices (DHT5B) 3. Predicate Device Predicate Name Quantec Spinal Measurement System 510(k) clearance K923792 Classification Name Device, Sensing, Optical Contour Product Code LDK Regulatory Classifi… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K923792.
How does its category compare?
All LDK devicesLDK Device, Sensing, Optical Contour: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LDK
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LDK
Too few LDK 510(k)s in any year since 2007 to give a median.
Recalls per year · LDK
No recall names LDK since 2007.
Adverse event reports per year · LDK
1in 2018
MAUDE reports naming product code LDK, 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 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Momentum Spine app is an optical contour sensing mobile application intended to quantify
asymmetries, assess body angles and curve progression related to postural asymmetries,
including scoliosis. The device is available directly to lay users (Over-the-Counter) and may also
be prescribed for use by physicians.
The device is intended for use in patients 8 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232023: Momentum Spine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232023
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