510(k) · Cleared
ClearedDepuy Pulse Cervical Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Apr 26, 2012 as substantially equivalent to K081917 (Depuy Spine, Inc., 2009) and 3 other predicates after a 65-day review. Its family tree reaches back 10 generations to 1984. 3 later devices descend from it.
- Decided
- Apr 26, 2012
- Review
- 65 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K841189 (1984). 40 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- This deviceK120517 Depuy Pulse Cervical Cage SystemMedos International SARL · 2012
- Descendant · cites it directly · 2 of its ownK173787 X-MESH® Expandable Cage System, OCELOT® Stackable Cage System…Medos International SARL · 2018
- Descendant · 2 generations on · 1 of its ownK192214 CarboClear VBR SystemCarboFix Orthopedics, Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK222874 CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 4 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- This deviceK120517 Depuy Pulse Cervical Cage SystemMedos International SARL · 2012
Most influential descendants
Showing 3 of 3 · See all- K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL · 2018 · cites it directly2descendants
- K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd. · 2019 · 2 generations on1descendant
- K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −4 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −3 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −2 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −1 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| 0 (this device) | K120517 | Depuy Pulse Cervical Cage System | Medos International SARL | 2012 | — |
| +1 | K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage… | Medos International SARL | 2018 | — |
| +2 | K192214 | CarboClear VBR System | CarboFix Orthopedics, Ltd. | 2019 | — |
| +3 | K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR System | Carbofix Orthpedics, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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 |
|---|---|---|---|
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 1…cation Name: Intervertebral Body Fusion Device Regulation Number: 888.3080 Predicate Devices: Bengal System - K081917, K 103488 Concorde System - K081917 Lumbar I1F Cage… | 2009 |
| * | K103488 | Concorde Bullet Cage SystemSummary page 1…me: Intervertebral Body Fusion Device Regulation Number: 888.3080 Predicate Devices: Bengal System - K081917, K 103488 Concorde System - K081917 Lumbar I1F Cage System -… | 2011 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…Bengal System - K081917, K 103488 Concorde System - K081917 Lumbar I1F Cage System - P960025' LDR Spine Cervical Interbody Fusion System - K091088 Device Description:… | 1999 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 1…em - K081917 Lumbar I1F Cage System - P960025' LDR Spine Cervical Interbody Fusion System - K091088 Device Description: The DePuy Pulse Cervical Cage System is designed for use as a cervical… | 2009 |
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 |
|---|---|---|---|
| K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System… | 2018 | 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 28 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 40 ancestors have a recall of any class.
- Of its descendants, K173787 (Medos International SARL, 2018) has gone furthest, with 2 descendants of its own.
- 35 other devices also cite its predicate K081917.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The DePuy Pulse Cervical Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. The DePuy Pulse Cervical Cage…
Read the full statement (108 words)
The DePuy Pulse Cervical Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. The DePuy Pulse Cervical Cage System implants are used to facilitate fusion in the cervical spine (C2 - T1) and are placed via an anterior approach using autogenous bone. DePuy Pulse Cervical Cage System implants are intended to be used with supplemental internal fixation system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120517: Depuy Pulse Cervical Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120517
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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