510(k) · Cleared
ClearedSkyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System, Uniplate 2 Anterior Cervical Plate Syst
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 6, 2013 as substantially equivalent to K052552 (Depuy Spine, Inc., 2005) and 3 other predicates after a 42-day review. Its family tree reaches back 4 generations to 1997. 3 later devices descend from it.
- Decided
- Sep 6, 2013
- Review
- 42 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K971730 (1997). 9 ancestors in all, the oldest K914362 (1992). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
- 3 generations backK040197 Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
- 2 generations backK082273 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2008
- 1 generation backK100070 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2010
- This deviceK132324 Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical…Medos International SARL · 2013
- Descendant · cites it directly · 2 of its ownK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK211205 Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019 · cites it directly2descendants
- K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024 · 2 generations on0descendants
- K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971730 | Depuy Motech Peak Polyaxial Anterior Cervical Plate System | Depuy, Inc. | 1997 | — |
| −3 | K040197 | Eagle Anterior Cervial Plate System | Depuyacromed | 2004 | — |
| −2 | K082273 | Uniplate Anterior Cervical Plate System | Depuy Spine, Inc. | 2008 | — |
| −1 | K100070 | Uniplate Anterior Cervical Plate System | Depuy Spine, Inc. | 2010 | — |
| 0 (this device) | K132324 | Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate… | Medos International SARL | 2013 | — |
| +1 | K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019 | — |
| +2 | K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024 | — |
| +2 | K211205 | Prase-C Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K052552 | Hybrid Anterior Cervical Plate SystemSummary page 1…ion orthosis per 21 CFR §888.3060 D. Predicate Device Name Trade name: SKYLINEO Anterior Cervical Plate System (K052552) UNIPLATEO Anterior Cervical Plate System (K042544) UNIPLATE12 Anterior Cervical Plat… | 2005 |
| * | K042544 | Uniplate Anterior Cervical Plate SystemSummary page 1…060 D. Predicate Device Name Trade name: SKYLINEO Anterior Cervical Plate System (K052552) UNIPLATEO Anterior Cervical Plate System (K042544) UNIPLATE12 Anterior Cervical Plate System (K(082273, K100070)… | 2004 |
| * | K082273 | Uniplate Anterior Cervical Plate SystemSummary page 3…posed modifications to the SKYLINE', UNIPLATE®, and UNIPLATE® 2 Anterior Cervical Plate Systems are identical to the predicate devices (K042544, K052552, K082273, and K100070) except for the proposed devices will be terminally sterilized via gamma radiation. The design, materials, i… | 2008 |
| * | K100070 | Uniplate Anterior Cervical Plate SystemSummary page 1…late System (K052552) UNIPLATEO Anterior Cervical Plate System (K042544) UNIPLATE12 Anterior Cervical Plate System (K(082273, K100070) 132324… | 2010 |
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 |
|---|---|---|---|
| K191584 | FORTICO Anterior Cervical Fixation System | 2019 | 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 16 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K191584 (Camber Spine Technologies, LLC, 2019) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K052552.
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. 2013, 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 SKYLINE Anterior Cervical Plate System isindicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: Instability caused by trauma; instability associated with correction of cervical lordaosis and kyphosis deformity; instability associated with pseudloarthrosis as a result of previously failed cervical…
Read the full statement (207 words)
The SKYLINE Anterior Cervical Plate System isindicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: Instability caused by trauma; instability associated with correction of cervical lordaosis and kyphosis deformity; instability associated with pseudloarthrosis as a result of previously failed cervical spine surgery; Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
The UNIPLATE Anterior Cervical Plate System and UINIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are Indicated for patients in which stability isdesired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to Ti. Indications Include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or Instability following surgery for the above indications.
The UNIPLATE and UNIPLATE 2Anterior Cervical Plate Systems are also indicated for treatment of spinal stenosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132324: Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System, Uniplate 2 Anterior Cervical Plate Syst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132324
Report an extraction error
Are you the manufacturer?
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