510(k) · Cleared
ClearedBALTEUM - ONE™ Lumbar Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huvexel Co., Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 25, 2022 as substantially equivalent to K200846 (Huvexel Co., Ltd., 2020) and 4 other predicates after a 107-day review. Its family tree reaches back 9 generations to 1999. 3 later devices descend from it.
- Decided
- Mar 25, 2022
- Review
- 107 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K990745 (1999). 23 ancestors in all, the oldest K962628 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 5 generations between
- 3 generations backK092108 Truss Thoracolumbar Plate SystemGlobus Medical, Inc. · 2009
- 2 generations backK120092 Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012
- 1 generation backK200846 Balteum™ Lumbar Plate SystemHuvexel Co., Ltd. · 2020
- This deviceK213820 BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK222572 FORTIS and HANA Anterior Cervical Plate System, Rex Anterior…Dio Medical Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK250446 Frida™ Anterior Cervical Plate SystemSpineup, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK231460 FORTIS and HANA Anterior Cervical Plate System, Rex Anterior…K&J Consulting Corp. · 2023
Show all 9 generations
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 8 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 7 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 6 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 5 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 4 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 3 generations backK092108 Truss Thoracolumbar Plate SystemGlobus Medical, Inc. · 2009
- 2 generations backK120092 Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012
- 1 generation backK200846 Balteum™ Lumbar Plate SystemHuvexel Co., Ltd. · 2020
- This deviceK213820 BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See all- K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation · 2022 · cites it directly2descendants
- K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc. · 2025 · 2 generations on0descendants
- K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −8 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −7 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −6 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −5 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −4 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −3 | K092108 | Truss Thoracolumbar Plate System | Globus Medical, Inc. | 2009 | — |
| −2 | K120092 | Plymouth Thoracolumbar Plate System | Globus Medical, Inc. | 2012 | — |
| −1 | K200846 | Balteum™ Lumbar Plate System | Huvexel Co., Ltd. | 2020 | — |
| 0 (this device) | K213820 | BALTEUM - ONE™ Lumbar Plate System | Huvexel Co., Ltd. | 2022 | — |
| +1 | K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate… | Dio Medical Corporation | 2022 | — |
| +2 | K250446 | Frida™ Anterior Cervical Plate System | Spineup, Inc. | 2025 | — |
| +2 | K231460 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate… | K&J Consulting Corp. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 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.
Planning a device in KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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 |
|---|---|---|---|
| * | K200846 | Balteum™ Lumbar Plate SystemSummary page 5…m is substantially equivalent to the legally marketed predicate devices. Predicate Device: Primary predicate: BALTEUM™ Lumbar Plate System (K200846) - HUVEXEL Co., Ltd Additional predicates: Globus Medical – Plymouth™ Thoracolumb… | 2020 |
| * | K120092 | Plymouth Thoracolumbar Plate SystemSummary page 5…- HUVEXEL Co., Ltd Additional predicates: Globus Medical – Plymouth™ Thoracolumbar Plate System (K120092), Globus Medical – TRUSS™ Thoracolumbar Plate System (K092108), NuVasive Lateral Plate System (K091071)… | 2012 |
| * | K092108 | Truss Thoracolumbar Plate SystemSummary page 5…tes: Globus Medical – Plymouth™ Thoracolumbar Plate System (K120092), Globus Medical – TRUSS™ Thoracolumbar Plate System (K092108), NuVasive Lateral Plate System (K091071) and Globus Medical - REVERE™ Stabilization System (K061202) T… | 2009 |
| * | K091071 | Nuvasive Lateral Plate SystemSummary page 5…mbar Plate System (K120092), Globus Medical – TRUSS™ Thoracolumbar Plate System (K092108), NuVasive Lateral Plate System (K091071) and Globus Medical - REVERE™ Stabilization System (K061202) Technological The BALTEUM - ONE™… | 2009 |
| * | K061202 | Revere Stabilization SystemSummary page 5…lumbar Plate System (K092108), NuVasive Lateral Plate System (K091071) and Globus Medical - REVERE™ Stabilization System (K061202) Technological The BALTEUM - ONE™ Lumbar Plate System was shown to be Characteristics substantially equivalent… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and… | 2022 | 2 |
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K222572 (Dio Medical Corporation, 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K200846.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The BALTEUM™ and BALTEUM - ONE™ Lumbar Plate System are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1‐L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1‐S1) spine instability as a result of fracture (including dislocation and subluxation)…
Read the full statement (116 words)
The BALTEUM™ and BALTEUM - ONE™ Lumbar Plate System are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1‐L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1‐S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213820 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213820: BALTEUM - ONE™ Lumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213820
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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