510(k) · Cleared
ClearedMambo, Model CS 18XX-XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulrich GmbH & Co. KG · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 21, 2010 as substantially equivalent to K052292 (X-Spine Systems, Inc., 2005) and 3 other predicates after a 417-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- May 21, 2010
- Review
- 417 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K922087 (1992). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 2 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 1 generation backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- This deviceK090861 Mambo, Model CS 18XX-XXUlrich GmbH & Co. KG · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −2 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −1 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| 0 (this device) | K090861 | Mambo, Model CS 18XX-XX | Ulrich GmbH & Co. KG | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K052292 | Spider Cervical Plating (SCP) SystemSummary page 1…8.3060, Spinal intervertebral body fixation orthosis Cervical System Substantial Equivalence Claimed to Predicate Device * Spider Cervical Plating System, K052292, X-Spine Systems * CLSP, K945700, Synthes (USA) * ABC2 Anterior Cervical Plating System. K974706 and K0000486, Aesculap® Inc. D… | 2005 |
| * | K945700 | Synthes (Usa) Anterior Cervical Vertebrae Plate SystemSummary page 1…y fixation orthosis Cervical System Substantial Equivalence Claimed to Predicate Device * Spider Cervical Plating System, K052292, X-Spine Systems * CLSP, K945700, Synthes (USA) * ABC2 Anterior Cervical Plating System. K974706 and K0000486, Aesculap® Inc. Device Description mamboTM is a m… | 1995 |
| * | K974706 | Aesculap Abc Cervical Plating SystemSummary page 1…quivalence Claimed to Predicate Device * Spider Cervical Plating System, K052292, X-Spine Systems * CLSP, K945700, Synthes (USA) * ABC2 Anterior Cervical Plating System. K974706 and K0000486, Aesculap® Inc. Device Description mamboTM is a modular implant system for the anterior operative stabilization o… | 1998 |
| * | K000486 | Abc Cervical Plating SystemSummary page 1…imed to Predicate Device * Spider Cervical Plating System, K052292, X-Spine Systems * CLSP, K945700, Synthes (USA) * ABC2 Anterior Cervical Plating System. K974706 and K0000486, Aesculap® Inc. Device Description mamboTM is a modular implant system for the anterior operative stabilization of the cervic… | 2000 |
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 18 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 14 other devices also cite its predicate K052292.
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. 2010, 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?
mambo TM is intended for anterior operative stabilization of the cervical spine, C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: Degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies Spondylolisthesis Trauma (i.e., fracture or dislocation) Spinal…
Read the full statement (103 words)
mambo TM is intended for anterior operative stabilization of the cervical spine, C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
Degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
Spondylolisthesis
Trauma (i.e., fracture or dislocation)
Spinal stenosis
Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
Tumor
Pseudoarthrosis
Failed previous fusion
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090861 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090861: Mambo, Model CS 18XX-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090861
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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