510(k) · Cleared
ClearedCrystal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Elements, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jan 24, 2008 after a 56-day review. The FDA summary names no predicate by number. 1 of the 1,155 devices in its family, counting itself, has a Class I recall. 1,154 later devices descend from it.
- Decided
- Jan 24, 2008
- Review
- 56 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 0
1,154 later devices descend from it, 27 citing it directly. 1 of the 1,155 devices in this family, counting this one, has a Class I recall.
- This deviceK073351 CrystalSpinal Elements, Inc. · 2008
- Descendant · cites it directly · 775 of its ownK112036 Calix PC Spinal Implant SystemX-Spine Systems, Inc. · 2011
- Descendant · cites it directly · 701 of its ownK090064 Eminent Spine Interbody Fusion SystemEminent Spine · 2009 · Recalled
- Descendant · 2 generations on · 694 of its ownK110632 Lucent or Lucent MagnumSpinal Elements, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 615 of its ownK122967 LucentSpinal Elements, Inc. · 2013
- Descendant · 3 generations on · 590 of its ownK140319 Coroent TI-C SystemNuvasive, Inc. · 2014
Showing 5 of 1,154 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 1,154 · See all- K112036Calix PC Spinal Implant SystemX-Spine Systems, Inc. · 2011 · cites it directly775descendants
- K090064Eminent Spine Interbody Fusion SystemEminent Spine · 2009 · cites it directly701descendants
- K110632Lucent or Lucent MagnumSpinal Elements, Inc. · 2012 · 2 generations on694descendants
- K122967LucentSpinal Elements, Inc. · 2013 · 3 generations on615descendants
- K140319Coroent TI-C SystemNuvasive, Inc. · 2014 · 3 generations on590descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073351 | Crystal | Spinal Elements, Inc. | 2008 | — |
| +1 | K112036 | Calix PC Spinal Implant System | X-Spine Systems, Inc. | 2011 | — |
| +1 | K090064 | Eminent Spine Interbody Fusion System | Eminent Spine | 2009 | 1 |
| +2 | K110632 | Lucent or Lucent Magnum | Spinal Elements, Inc. | 2012 | 1 |
| +3 | K122967 | Lucent | Spinal Elements, Inc. | 2013 | — |
| +3 | K140319 | Coroent TI-C System | Nuvasive, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 18 | 0 |
| 2012 | 20 | 0 |
| 2013 | 24 | 0 |
| 2014 | 50 | 0 |
| 2015 | 50 | 0 |
| 2016 | 64 | 0 |
| 2017 | 105 | 0 |
| 2018 | 90 | 0 |
| 2019 | 96 | 0 |
| 2020 | 97 | 0 |
| 2021 | 86 | 1 |
| 2022 | 81 | 0 |
| 2023 | 103 | 0 |
| 2024 | 102 | 0 |
| 2025 | 81 | 0 |
| 2026 | 77 | 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.
1 device in this family has a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (1,154)
See all 1,15427 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112036 | Calix PC Spinal Implant System | 2011 | 775 |
| K090064 | Eminent Spine Interbody Fusion System | 2009 | 701 |
| K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | 2009 | 554 |
| K103033 | Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx | 2011 | 505 |
| K110733 | Daytona Anterior Cervical Cage | 2011 | 481 |
| K083118 | Spinal Usa Anterior Cervical Interbody Fusion Device | 2009 | 458 |
| K080971 | Spinesmith Cimplicity Spinal System | 2008 | 406 |
| K093093 | Small Plateau Spacer System | 2010 | 393 |
| K102606 | Avs Anchor-C Cervical Cage System | 2011 | 384 |
| K101812 | Construx Mini Peek Spacer System | 2010 | 291 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K112036 (X-Spine Systems, Inc., 2011) has gone furthest, with 775 descendants of its own.
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. 2008, 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?
When used as a vertebral body replacement, the Crystal device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e.…
Read the full statement (164 words)
When used as a vertebral body replacement, the Crystal device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
When used as an intervertebral body fusion device, the Crystal device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073351: Crystal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073351
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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