510(k) · Cleared
Recalled · Class II · 2015Nakoma Acp
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 Nov 6, 2014 as substantially equivalent to K091134 (Custom Spine, Inc., 2009) and 1 other predicate after a 107-day review. Its family tree reaches back 5 generations to 1992. 8 later devices descend from it. It has been recalled once.
- Decided
- Nov 6, 2014
- Review
- 107 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K922087 (1992). 23 ancestors in all, the oldest K913730 (1992). 8 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 4 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 3 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 2 generations backK040017 Abc Caudal and Cranial Extension Plate (E-Plate)Aesculap, Inc. · 2004
- 1 generation backK100243 Quintex Cervical Plating SystemAesculap Implant Systems, LLC · 2010 · Recalled
- This deviceK141993 Nakoma AcpAlliance Partners, LLC · 2014
- Descendant · cites it directly · 3 of its ownK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
- Descendant · 2 generations on · 2 of its ownK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK173128 Alamo® CAlliance Partners, LLC · 2018
- Descendant · 3 generations on · 1 of its ownK250486 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025
- Descendant · 4 generations on · 0 of its ownK261451 ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023 · cites it directly3descendants
- K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024 · 2 generations on2descendants
- K173128Alamo® CAlliance Partners, LLC · 2018 · cites it directly2descendants
- K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025 · 3 generations on1descendant
- K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −4 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −3 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −2 | K040017 | Abc Caudal and Cranial Extension Plate (E-Plate) | Aesculap, Inc. | 2004 | — |
| −1 | K100243 | Quintex Cervical Plating System | Aesculap Implant Systems, LLC | 2010 | 1 |
| 0 (this device) | K141993 | Nakoma Acp | Alliance Partners, LLC | 2014 | — |
| +1 | K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023 | — |
| +2 | K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024 | — |
| +1 | K173128 | Alamo® C | Alliance Partners, LLC | 2018 | — |
| +3 | K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025 | — |
| +4 | K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026 | — |
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 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K091134 | Custom Spine Regent Anterior Cervical PlateSummary page 4…ode: KWQ (a)(3) Predicate Devices: Primary: Custom Spine-REGENT (K091134) Secondary: Aesculap-QUINTEX (K100243) (a)(4) Device Description:… | 2009 |
| * | K100243 | Quintex Cervical Plating SystemSummary page 4…mary: Custom Spine-REGENT (K091134) Secondary: Aesculap-QUINTEX (K100243) (a)(4) Device Description: The Nakoma Anterior Cervical Plating (ACP) system is used for spinal fusion surgery to pr… | 2010 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 9, 2015 | Class II | Z-1989-2015 | Device Design | Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K231766 (Kyocera Medical Technologies Inc. (KMTI), 2023) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K091134.
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. 2014, 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 Nakoma ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patents with the following indications:
• Degenerative Disk Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• Pseudoarthrosis
• Failed previous fusions
• Spondylolisthesis
• Spinal Stenosis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141993: Nakoma Acp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141993
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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