510(k) · Cleared
ClearedMedina Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Partners, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 6, 2020 as substantially equivalent to K141993 (Alliance Partners, LLC, 2014) and 2 other predicates after a 59-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Aug 6, 2020
- Review
- 59 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K922087 (1992). 28 ancestors in all, the oldest K913730 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 5 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 4 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 3 generations backK040017 Abc Caudal and Cranial Extension Plate (E-Plate)Aesculap, Inc. · 2004
- 2 generations backK100243 Quintex Cervical Plating SystemAesculap Implant Systems, LLC · 2010 · Recalled
- 1 generation backK141993 Nakoma AcpAlliance Partners, LLC · 2014 · Recalled
- This deviceK201521 Medina Anterior Cervical Plate SystemAlliance Partners, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −5 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −4 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −3 | K040017 | Abc Caudal and Cranial Extension Plate (E-Plate) | Aesculap, Inc. | 2004 | — |
| −2 | K100243 | Quintex Cervical Plating System | Aesculap Implant Systems, LLC | 2010 | 1 |
| −1 | K141993 | Nakoma Acp | Alliance Partners, LLC | 2014 | 1 |
| 0 (this device) | K201521 | Medina Anterior Cervical Plate System | Alliance Partners, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K141993 | Nakoma AcpSummary page 5…Trade or Proprietary or Manufacturer Predicate Model Name Type K141993 Nakoma ACP Alliance Partners, LLC Primary K060025 Slimplicity Ant… | 2014 |
| * | K060025 | Slimplicity Anterior Cervical Plate SystemSummary page 5…Model Name Type K141993 Nakoma ACP Alliance Partners, LLC Primary K060025 Slimplicity Anterior Cervical Spinal USA Additional Plate System… | 2006 |
| * | K091936 | Blade Anterior Cervical Plate SystemSummary page 5…lliance Partners, LLC Primary K060025 Slimplicity Anterior Cervical Spinal USA Additional Plate System K091936 Blade™ Anterior Cervical Nexxt Medical, Inc. Additional Plate System… | 2010 |
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 28 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- 3 of the 28 ancestors have a recall of any class.
- 2 other devices also cite its predicate K141993.
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. 2020, 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 Medina ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Medina ACP System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following indications: x Degenerative disk disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic…
Read the full statement (97 words)
The Medina ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Medina ACP System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following indications:
x Degenerative disk disease (DDD) (defined by neck pain of discogenic origin with
degeneration of the disc confirmed by patient history and radiographic studies)
x Trauma (including fractures)
x Tumors
x Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
x Pseudoarthrosis
x Failed previous fusions
x Spondylolisthesis
x Spinal Stenosis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201521: Medina Anterior 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/K201521
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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