510(k) · Cleared
ClearedDepuy Pulse Anterior Cerical 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 Nov 21, 2011 as substantially equivalent to K103491 (A Johnson & Johnson Company, 2011) and 2 other predicates after a 63-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Nov 21, 2011
- Review
- 63 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K953730 (1995). 9 ancestors in all, the oldest K914362 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 3 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 2 generations backK052552 Hybrid Anterior Cervical Plate SystemDepuy Spine, Inc. · 2005 · Recalled
- 1 generation backK103491 Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company · 2011
- This deviceK112724 Depuy Pulse Anterior Cerical Plate SystemMedos International SARL · 2011
- Descendant · cites it directly · 0 of its ownK171439 EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior…Medos International SARL · 2017
- Descendant · cites it directly · 0 of its ownK123167 Depuy Pulse Anterior Cervical in-Line Plate SystemMedos International SARL · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −3 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −2 | K052552 | Hybrid Anterior Cervical Plate System | Depuy Spine, Inc. | 2005 | 7 |
| −1 | K103491 | Skyline Anterior Cervical Plate System | A Johnson & Johnson Company | 2011 | — |
| 0 (this device) | K112724 | Depuy Pulse Anterior Cerical Plate System | Medos International SARL | 2011 | — |
| +1 | K171439 | EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical… | Medos International SARL | 2017 | — |
| +1 | K123167 | Depuy Pulse Anterior Cervical in-Line Plate System | Medos International SARL | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K103491 | Skyline Anterior Cervical Plate SystemSummary page 1…ody Classification Name: Spinal Intervertebral Body Fixation Orthosis Regulation Number: 888.3060 Predicate Devices: Skyline Anterior Cervical Plate System - K 103491 Slim-Loc Anterior Cervical Plate System - K01 3877 Uniplate Anterior Cervical Plate… | 2011 |
| * | K013877 | Codman Slim-Loc SystemSummary page 1…gulation Number: 888.3060 Predicate Devices: Skyline Anterior Cervical Plate System - K 103491 Slim-Loc Anterior Cervical Plate System - K01 3877 Uniplate Anterior Cervical Plate System - K082273 Device Description: The DePuy Pulse Anterior Cervic… | 2001 |
| * | K082273 | Uniplate Anterior Cervical Plate SystemSummary page 1…rvical Plate System - K 103491 Slim-Loc Anterior Cervical Plate System - K01 3877 Uniplate Anterior Cervical Plate System - K082273 Device Description: The DePuy Pulse Anterior Cervical Plate System is intended for anterior screw fix… | 2008 |
What descends from it? (2)
2 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)
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 5 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K171439 (Medos International SARL, 2017) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K103491.
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. 2011, 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 DePuy 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…
Read the full statement (101 words)
The DePuy 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/K112724 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112724: Depuy Pulse Anterior Cerical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112724
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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