510(k) · Cleared
CleareduNion® MAX Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulrich Medical USA, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 18, 2024 as substantially equivalent to K150666 (Ulrich Medical USA, 2015) and 1 other predicate after a 24-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Mar 18, 2024
- Review
- 24 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K971730 (1997). 29 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 7 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
- 6 generations backK013439 Anterior Cervical Plate SystemScien'Tx USA, Inc. · 2002
- 5 generations backK042317 Cervical PlateScient'X · 2004
- 4 generations backK070681 Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc. · 2007 · Recalled
- 3 generations backK112533 Zavation Cervical Plate SystemZavation, LLC · 2011
- 2 generations backK130030 Zavation Cervical Plate SystemZavation, LLC · 2013
- 1 generation backK150666 uNion Cervical Plate SystemUlrich Medical USA · 2015 · Recalled
- This deviceK240515 uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971730 | Depuy Motech Peak Polyaxial Anterior Cervical Plate System | Depuy, Inc. | 1997 | — |
| −6 | K013439 | Anterior Cervical Plate System | Scien'Tx USA, Inc. | 2002 | — |
| −5 | K042317 | Cervical Plate | Scient'X | 2004 | — |
| −4 | K070681 | Next Generation Anterior Cervical Plating System | Alphatec Spine, Inc. | 2007 | 1 |
| −3 | K112533 | Zavation Cervical Plate System | Zavation, LLC | 2011 | — |
| −2 | K130030 | Zavation Cervical Plate System | Zavation, LLC | 2013 | — |
| −1 | K150666 | uNion Cervical Plate System | Ulrich Medical USA | 2015 | 1 |
| 0 (this device) | K240515 | uNion® MAX Cervical Plate System | Ulrich Medical USA, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K150666 | uNion Cervical Plate SystemSummary page 4…nents are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136). Primary Predicate: uNion Cervical Plate System (ulrich medical USA – K150666) Predicate/Reference: MaxAn® Anterior Cervical Plate System (Biomet Spine – K133518) Performance Data: ASTM F1717 mech… | 2015 |
| * | K133518 | Maxan Anterior Cervical Plate SystemSummary page 4…F136). Primary Predicate: uNion Cervical Plate System (ulrich medical USA – K150666) Predicate/Reference: MaxAn® Anterior Cervical Plate System (Biomet Spine – K133518) Performance Data: ASTM F1717 mechanical testing of the worst case uNion MAX constructs included… | 2014 |
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?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 29 ancestors have a recall of any class.
- 2 other devices also cite its predicate K150666.
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. 2024, 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 uNion MAX Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240515: uNion® MAX Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240515
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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