510(k) · Cleared
ClearedENZA-A Titanium ALIF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camber Spine Technologies · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Apr 18, 2018 after a 167-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Apr 18, 2018
- Review
- 167 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK173432 ENZA-A Titanium ALIFCamber Spine Technologies · 2018
- Descendant · cites it directly · 2 of its ownK203503 Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK233972 Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies · 2024
- Descendant · 3 generations on · 0 of its ownK250247 panaSIa SI Fusion SystemWenzel Spine, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK221324 ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies · 2023
Most influential descendants
Showing 4 of 4 · See all- K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC · 2022 · cites it directly2descendants
- K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies · 2024 · 2 generations on1descendant
- K250247panaSIa SI Fusion SystemWenzel Spine, Inc. · 2025 · 3 generations on0descendants
- K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K173432 | ENZA-A Titanium ALIF | Camber Spine Technologies | 2018 | — |
| +1 | K203503 | Camber Sacroiliac (SI) Fixation System | Camber Spine Technologies, LLC | 2022 | — |
| +2 | K233972 | Camber Sacroiliac (SI) Fixation System | Camber Spine Technologies | 2024 | — |
| +3 | K250247 | panaSIa SI Fusion System | Wenzel Spine, Inc. | 2025 | — |
| +1 | K221324 | ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) | Camber Spine Technologies | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Camber Spine ENZA Zero-Profile Anterior Interbody Fusion Device Named without a submission number | |
| * | — | Camber Spine SPIRA Open Matrix ALIF Device Named without a submission number |
What descends from it? (4)
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?
- Of its descendants, K203503 (Camber Spine Technologies, LLC, 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The Camber Spine Technologies ENZA™-A Titanium ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I…
Read the full statement (112 words)
The Camber Spine Technologies ENZA™-A Titanium ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies ENZA™-A Titanium ALIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies ENZA™-A Titanium ALIF system must be used with autogenous graft material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173432 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173432: ENZA-A Titanium ALIF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173432
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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