510(k) · Cleared
ClearedEAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System
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 Jul 20, 2017 as substantially equivalent to K072546 (Depuy Spine, Inc., 2007) and 9 other predicates after a 65-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jul 20, 2017
- Review
- 65 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 5 generations to K953730 (1995). 15 ancestors in all, the oldest K914362 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 4 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 3 generations backK052552 Hybrid Anterior Cervical Plate SystemDepuy Spine, Inc. · 2005 · Recalled
- 2 generations backK103491 Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company · 2011
- 1 generation backK112724 Depuy Pulse Anterior Cerical Plate SystemMedos International SARL · 2011
- This deviceK171439 EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior…Medos International SARL · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −4 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −3 | K052552 | Hybrid Anterior Cervical Plate System | Depuy Spine, Inc. | 2005 | 7 |
| −2 | K103491 | Skyline Anterior Cervical Plate System | A Johnson & Johnson Company | 2011 | — |
| −1 | K112724 | Depuy Pulse Anterior Cerical Plate System | Medos International SARL | 2011 | — |
| 0 (this device) | K171439 | EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical… | Medos International SARL | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 2004 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 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? (10)
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 |
|---|---|---|---|
| * | K072546 | Swift Plus Anterior Cervical Plate SystemSummary page 6…39 Page 2 of 5 Primary Predicate: SWIFT Plus Anterior Cervical Plate System (K072546) Additional Predicate Devices: EAGLE Plus Anterior Cervical Plates (K070994) EAGLE Plus Micro Anterio… | 2007 |
| * | K070994 | Eagle + Anterior Cervical Plate SystemSummary page 6…Page 2 of 5 Primary Predicate: SWIFT Plus Anterior Cervical Plate System (K072546) Additional Predicate Devices: EAGLE Plus Anterior Cervical Plates (K070994) EAGLE Plus Micro Anterior Cervical Plate System (K080191) PULSE Anterior Cervical… | 2007 |
| * | K080191 | Eagle Plus Micro Anterior Cervical Plate SystemSummary page 6…System (K072546) Additional Predicate Devices: EAGLE Plus Anterior Cervical Plates (K070994) EAGLE Plus Micro Anterior Cervical Plate System (K080191) PULSE Anterior Cervical Plate System (K112724) SKYLINE Anterior Cervical Plate Sys… | 2008 |
| * | K112724 | Depuy Pulse Anterior Cerical Plate SystemSummary page 6…r Cervical Plates (K070994) EAGLE Plus Micro Anterior Cervical Plate System (K080191) PULSE Anterior Cervical Plate System (K112724) SKYLINE Anterior Cervical Plate System (K052552, K103491) SLIM LOC Anterior Cervic… | 2011 |
| * | K052552 | Hybrid Anterior Cervical Plate SystemSummary page 6…rior Cervical Plate System (K080191) PULSE Anterior Cervical Plate System (K112724) SKYLINE Anterior Cervical Plate System (K052552, K103491) SLIM LOC Anterior Cervical Plate System (K013877) UNIPLATE Anterior Cervi… | 2005 |
| * | K103491 | Skyline Anterior Cervical Plate SystemSummary page 6…ical Plate System (K080191) PULSE Anterior Cervical Plate System (K112724) SKYLINE Anterior Cervical Plate System (K052552, K103491) SLIM LOC Anterior Cervical Plate System (K013877) UNIPLATE Anterior Cervical Plate… | 2011 |
| * | K013877 | Codman Slim-Loc SystemSummary page 6…l Plate System (K112724) SKYLINE Anterior Cervical Plate System (K052552, K103491) SLIM LOC Anterior Cervical Plate System (K013877) UNIPLATE Anterior Cervical Plate System (K042544) UNIPLATE 2 Anterior Cervical Pla… | 2001 |
| * | K042544 | Uniplate Anterior Cervical Plate SystemSummary page 6…Plate System (K052552, K103491) SLIM LOC Anterior Cervical Plate System (K013877) UNIPLATE Anterior Cervical Plate System (K042544) UNIPLATE 2 Anterior Cervical Plate System (K082273, K100070) Submission Purpose: Obtain clearance… | 2004 |
| * | K082273 | Uniplate Anterior Cervical Plate SystemSummary page 6…ervical Plate System (K013877) UNIPLATE Anterior Cervical Plate System (K042544) UNIPLATE 2 Anterior Cervical Plate System (K082273, K100070) Submission Purpose: Obtain clearance for MR Conditional Labeling for the systems listed. Device Descriptions:… | 2008 |
| * | K100070 | Uniplate Anterior Cervical Plate SystemSummary page 6…late System (K013877) UNIPLATE Anterior Cervical Plate System (K042544) UNIPLATE 2 Anterior Cervical Plate System (K082273, K100070) Submission Purpose: Obtain clearance for MR Conditional Labeling for the systems listed. Device Descriptions: SWIFT Plu… | 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 22 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 1 other device also cites its predicate K072546.
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. 2017, 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 SLIM LOC Anterior Cervical Plate System and SKYLINE Anterior Cervical Plate System are indicated 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 lordosis and kyphosis deformity; instability associated with pseudoarthrosis as…
Read the full statement (345 words)
The SLIM LOC Anterior Cervical Plate System and SKYLINE Anterior Cervical Plate System are indicated 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 lordosis and kyphosis deformity; instability associated with pseudoarthrosis 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 EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, and UNIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
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 2 Anterior Cervical Plate Systems and the EAGLE Plus Micro Anterior Cervical Plate System are also indicated for treatment of spinal stenosis.
The PULSE Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to T1 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 lordosis and kyphosis deformity; instability associated with pseudoarthrosis 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171439: EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 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/K171439
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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