510(k) Report

510(k) · Cleared

Cleared

Optimus ALIF System

K160291510(k) SpecialCleared Feb 18, 201615-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Amendia, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

Cleared on Feb 18, 2016 as substantially equivalent to K132596 (Custom Spine, Inc., 2014) after a 15-day review. Its family tree reaches back 14 generations to 1984.

Decided
Feb 18, 2016
Review
15 days
Class
Class II
Product code
OVD
Recalls
None
Predicates
1

Its longest line of descent runs back 14 generations to K841189 (1984). 77 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 2 other ancestors2011: 1 other ancestor2009: 3 other ancestors2008: 5 other ancestors2007: 8 other ancestors2006: 2 other ancestors2005: 4 other ancestors2004: 7 other ancestors2003: 8 other ancestors2001: 10 other ancestors2000: 1 other ancestor2002: 8 other ancestors1999: 2 other ancestors1996: 2 other ancestorsK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007×2: 2 generations cleared close together, K080083 (2008), K073109 (2008) K103369 · Vault Alif System · Spinal USA · 2011K130445 · Vault Alif System · Spinal USA · 2013K132596 · Proposed Optimus · Custom Spine, Inc. · 2014 · recalled1980199020002010
Other ancestors, by generation 2 generations back: 5 other ancestors3 generations back: 15 other ancestors4 generations back: 20 other ancestors5 generations back: 9 other ancestors6 generations back: 6 other ancestors7 generations back: 6 other ancestors8 generations back: 2 other ancestors K132596 · Proposed Optimus · Custom Spine, Inc. · 2014 · recalledK130445 · Vault Alif System · Spinal USA · 2013K103369 · Vault Alif System · Spinal USA · 2011K073109 · Stalif TT Intervertebral Body Fusion System · Surgicraft, Ltd. · 2008K080083 · Intrepid Spinal System · Medtronic Sofamor Danek · 2008 · recalledK072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50
  1. Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 10 generations between
  3. 3 generations backK103369 Vault Alif SystemSpinal USA · 2011
  4. 2 generations backK130445 Vault Alif SystemSpinal USA · 2013
  5. 1 generation backK132596 Proposed OptimusCustom Spine, Inc. · 2014 · Recalled
  6. This deviceK160291 Optimus ALIF SystemAmendia, Inc. · 2016
Show all 14 generations
  1. Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 5 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
  11. 4 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
  12. 3 generations backK103369 Vault Alif SystemSpinal USA · 2011
  13. 2 generations backK130445 Vault Alif SystemSpinal USA · 2013
  14. 1 generation backK132596 Proposed OptimusCustom Spine, Inc. · 2014 · Recalled
  15. This deviceK160291 Optimus ALIF SystemAmendia, Inc. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−13K990148Stackable Cage SystemDepuy Motech Acromed1999—
−12K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−11K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−10K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−9K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−8K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−7K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−6K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−5K080083Intrepid Spinal SystemMedtronic Sofamor Danek20088
−4K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008—
−3K103369Vault Alif SystemSpinal USA2011—
−2K130445Vault Alif SystemSpinal USA2013—
−1K132596Proposed OptimusCustom Spine, Inc.20141
0 (this device)K160291Optimus ALIF SystemAmendia, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
2001100
200280
200380
200470
200540
200620
200780
200850
200930
201110
201220
FIG. 1 — Lineage of K160291, 1984–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K132596Proposed Optimus
Summary page 4
…ALIF System Device Product Code and Classification: OVD, 888.3080, Class II, Intervertebral body fusion device Primary Predicate Device: Optimus ALIF System (K132596) Purpose of Submission: This special 510(k) is intended to gain clearance for a modification to the Optimus Stand-Alone ALIF Sys…
Custom Spine, Inc.20141

Also cleared against K132596: 3 other devices →

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 32 years and passes through 12 companies; a new generation was cleared every 1.7 years on median.
  • 12 of the 77 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K132596.

How does its category compare?

All OVD devices

OVD 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

2007: 22008: 82009: 32010: 82011: 92012: 102013: 112014: 142015: 122016: 132017: 122018: 142019: 122020: 142021: 72022: 142023: 122024: 122025: 102026 (partial year): 8
2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVD

100in 2025

2008: 84 days median2009: 152 days median2010: 117 days median2011: 167 days median2012: 78 days median2013: 137 days median2014: 139 days median2015: 166 days median2016: 127 days median2017: 127 days median2018: 126 days median2019: 91 days median2020: 91 days median2021: 108 days median2022: 133 days median2023: 92 days median2024: 110 days median2025: 100 days median2026 (partial year): 93 days median
2007high 167 (2011) · low 78 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OVD

1in 2025

2013: 42016: 12021: 12022: 12025: 12026 (partial year): 1
2007high 4 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OVD

50in 2025

2009: 22010: 22011: 62012: 162013: 172014: 352015: 432016: 552017: 722018: 1122019: 1712020: 2032021: 2212022: 742023: 672024: 922025: 50
2007high 221 (2021) · low 0 (2007)2025

MAUDE reports naming product code OVD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
200888400
2009315202
2010811702
2011916706
20121078016
201311137417
201414139035
201512166043
201613127155
201712127072
2018141260112
201912910171
202014910203
202171081221
202214133174
20231292067
202412110092
202510100150
20268931—

What is it indicated for?

The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The…

Read the full statement (117 words)

The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment.

The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a stand-alone system intended to be used with bone screws, autogenous bone graft and requires no additional supplementary fixations. One device is used per intervertebral space.

Indications for use as stated in the FDA summary.

Also cleared against K132596

3 other devices cite the same predicate.

  • K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc. · 2026
  • K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd. · 2021
  • K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd. · 2020

More from Amendia, Inc.

16 FDA decisions under this applicant name. See the company

  • K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
  • K161842Overwatch Spine SystemAmendia, Inc. · 20161 recall
  • K152920Savannah-T® Pedicle Screw SystemAmendia, Inc. · 20161 recall
  • K153152Syzygy Stabilization SystemAmendia, Inc. · 20162 recalls
  • K152972Amendia Stand-Alone Cervical SystemAmendia, Inc. · 20162 recalls

Recent decisions in OVD

The OVD category page

  • K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium…INNO Holdings Inc. DBA Innovasis · 2026
  • K261408SABER-XA SystemElevation Spine · 2026
  • K261809Interwedge® Standalone LateralFoundation Surgical Group · 2026
  • K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc. · 2026
  • K260810Anteralign LS coverplateTyber Medical, LLC · 2026

https://510kreport.com/device/K160291 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160291: Optimus ALIF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160291

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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