510(k) · Cleared
ClearedENZA Zero-Profile Anterior Interbody Fusion
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 May 3, 2016 as substantially equivalent to K110327 (Ldr Spine USA, 2011) and 1 other predicate after a 127-day review. Its family tree reaches back 13 generations to 1984. 4 later devices descend from it.
- Decided
- May 3, 2016
- Review
- 127 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K841189 (1984). 56 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 1 generation backK101310 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010
- This deviceK153720 ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies · 2016
- Descendant · cites it directly · 3 of its ownK180963 Roccia Alif, Roccia TlifSilony Medical GmbH · 2018
- Descendant · 2 generations on · 1 of its ownK212075 ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK221172 FOCUS Interbody SystemOc Medical Devices · 2022
- Descendant · 2 generations on · 0 of its ownK190680 Favo S-TlifSilony Medical GmbH · 2019
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 1 generation backK101310 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010
- This deviceK153720 ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies · 2016
Most influential descendants
Showing 4 of 4 · See all- K180963Roccia Alif, Roccia TlifSilony Medical GmbH · 2018 · cites it directly3descendants
- K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021 · 2 generations on1descendant
- K221172FOCUS Interbody SystemOc Medical Devices · 2022 · 3 generations on0descendants
- K190680Favo S-TlifSilony Medical GmbH · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −3 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −2 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −1 | K101310 | VU Apod Intervertebral Body Fusion Device | Theken Spine, LLC | 2010 | — |
| 0 (this device) | K153720 | ENZA Zero-Profile Anterior Interbody Fusion | Camber Spine Technologies | 2016 | — |
| +1 | K180963 | Roccia Alif, Roccia Tlif | Silony Medical GmbH | 2018 | — |
| +2 | K212075 | ShurFit Lumbar Interbody System | Precision Spine, Inc. | 2021 | — |
| +3 | K221172 | FOCUS Interbody System | Oc Medical Devices | 2022 | — |
| +2 | K190680 | Favo S-Tlif | Silony Medical GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K110327 | LDR Spine Roi-a Interbody Fusion SystemSummary page 4…21 CFR §888.3080, Intervertebral body fusion device Class: II Product Codes: OVD Primary Predicate: LDR ROI-A (K110327) Additional Predicate: Theken Spine Vu aPOD (K101310) Reference Devices: Renovis S128 PEEK ALIF (K131122), C… | 2011 |
| * | K101310 | VU Apod Intervertebral Body Fusion DeviceSummary page 4…ass: II Product Codes: OVD Primary Predicate: LDR ROI-A (K110327) Additional Predicate: Theken Spine Vu aPOD (K101310) Reference Devices: Renovis S128 PEEK ALIF (K131122), Centinel Spine STALIF TT (K073109… | 2010 |
| † | K131122 | S128 Anterior Lumbar Interbody Fusion (Alif) System | 2013 |
| † | K073109 | Stalif TT Intervertebral Body Fusion System | 2008 |
| † | K123993 | Solus Anterior Lumbar Interbody Fusion (Alif) System | 2013 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180963 | Roccia Alif, Roccia Tlif | 2018 | 3 |
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 32 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 12 of the 56 ancestors have a recall of any class.
- Of its descendants, K180963 (Silony Medical GmbH, 2018) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K110327.
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. 2016, 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 Zero-Profile Anterior Interbody Fusion is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients…
Read the full statement (148 words)
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is intended to be used with additional FDA-cleared supplementary fixation systems.
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion system must be used with bone grafting material (autograft only).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153720: ENZA Zero-Profile Anterior Interbody Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153720
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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