510(k) · Cleared
ClearedInfill Cervical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pinnacle Spine Group, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on May 5, 2014 as substantially equivalent to K083637 (X-Spine Systems, Inc., 2009) and 2 other predicates after a 115-day review. Its family tree reaches back 9 generations to 1984.
- Decided
- May 5, 2014
- Review
- 115 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K841189 (1984). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 1 generation backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- This deviceK140066 Infill CervicalPinnacle Spine Group, LLC · 2014
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 5 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 4 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 3 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 1 generation backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- This deviceK140066 Infill CervicalPinnacle Spine Group, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −5 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −4 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −3 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −1 | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems | Depuy Spine, Inc. | 2009 | — |
| 0 (this device) | K140066 | Infill Cervical | Pinnacle Spine Group, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K083637 | Calix Spinal Implant SystemSummary page 1…Class 11 CLASSIFICATION: REGULATION 888.3080 (product code: ODP) NUMBER PREDICATE DEVICES: Calix- Cervical Spinal Implant System (K083637, KI 12036) Bengal Cervical System (K08 1917) Substantially Equivalent To: The InFill® Cervical Inte… | 2009 |
| * | K112036 | Calix PC Spinal Implant SystemSummary page 2…inal Implant System (K081917) body fusion System (K083637, devices K112036) Shape Box-shaped, bullet SAME SAME nose Bone to im… | 2011 |
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 1…8.3080 (product code: ODP) NUMBER PREDICATE DEVICES: Calix- Cervical Spinal Implant System (K083637, KI 12036) Bengal Cervical System (K08 1917) Substantially Equivalent To: The InFill® Cervical Interbody Fusion device are substantially equivalent in intended use, princi… | 2009 |
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 30 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 20 ancestors has a recall.
- 3 other devices also cite its predicate K083637.
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. 2014, 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 InFill® cervical interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The InFill® cervical interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® is intended for use at one level in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc…
Read the full statement (142 words)
The InFill® cervical interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The InFill® cervical interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® is intended for use at one level in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The devices are to be used in patients who have had at least six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at the involved level may be treated with this device. The InFill® cervical interbody fusion device is intended to be used with supplemental internal fixation systems that are cleared by the FDA for use in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140066: Infill Cervical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140066
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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