510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Opticage (R) Expandable Interbody Fusion Device

K160464510(k) SpecialCleared Apr 4, 201645-day reviewClass II21 CFR 888.3080Recalls 2

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

Interventional Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Apr 4, 2016 as substantially equivalent to K152156 (Interventional Spine, Inc., 2015) after a 45-day review. Its family tree reaches back 1 generation to 2015. 9 later devices descend from it. It has been recalled 2 times.

Decided
Apr 4, 2016
Review
45 days
Class
Class II
Product code
MAX
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K152156 (2015). 9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2019: 2 descendants cleared2018: 1 descendant cleared2023: 2 descendants cleared2021: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant clearedK152156 · Opticage Expandable Interbody Fusion Device · Interventional Spine, Inc. · 2015 · recalled201620182020202220242026
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K152156 · Opticage Expandable Interbody Fusion Device · Interventional Spine, Inc. · 2015 · recalled0+5
  1. Root · 1 generation backK152156 Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc. · 2015 · Recalled
  2. This deviceK160464 Opticage (R) Expandable Interbody Fusion DeviceInterventional Spine, Inc. · 2016
  3. Descendant · cites it directly · 8 of its ownK171425 Concorde LiftMedos International SARL · 2017 · Recalled
  4. Descendant · 2 generations on · 5 of its ownK190708 AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2019
  5. Descendant · 3 generations on · 3 of its ownK203531 XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc. · 2021
  6. Descendant · 4 generations on · 2 of its ownK221719 ABTross ALIF Expandable Cage SystemAegis Spine, Inc. · 2022
  7. Descendant · 3 generations on · 1 of its ownK231680 AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd. · 2023

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12019: 22021: 12022: 12023: 22024: 1
2017high 2 (2019) · low 0 (2020)2026

Most influential descendants

Showing 5 of 9 · See all
  • K171425Concorde LiftMedos International SARL · 2017 · cites it directly8descendants
  • K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2019 · 2 generations on5descendants
  • K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc. · 2021 · 3 generations on3descendants
  • K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc. · 2022 · 4 generations on2descendants
  • K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd. · 2023 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K152156Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20152
0 (this device)K160464Opticage (R) Expandable Interbody Fusion DeviceInterventional Spine, Inc.2016—
+1K171425Concorde LiftMedos International SARL20172
+2K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.2019—
+3K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.2021—
+4K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.2022—
+3K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
201920
202110
202210
202320
202410
FIG. 1 — Lineage of K160464, 2015–2024Source: 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 MAX? 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 MAX device

  1. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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
*K152156Opticage Expandable Interbody Fusion Device
Summary page 4
…: Class II REGULATION NUMBER 888.3080 (product code: MAX) PRIMARY PREDICATE DEVICE: Opticage® Expandable Interbody Fusion Device (K152156) Purpose of Submission The purpose of this special 510(k) submission is to obtain market clearance for twenty-four (24) addition…
Interventional Spine, Inc.20152

Also cleared against K152156: 1 other device →

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K171425Concorde LiftMedos International SARL20178

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 8, 2019Class IIZ-1226-2019Under Investigation by firmA complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Nov 22, 2016Class IIZ-0941-2017Device DesignDuring implantation, the proximal end of the device could separate if the angle between the device and insertion instrument is too steep. This separation will prevent the device from expanding.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K171425 (Medos International SARL, 2017) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K152156.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

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

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, 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
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

The Opticage® Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral…

Read the full statement (166 words)

The Opticage® Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is

indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous

levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved

level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients

may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation

systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices

and posterior pedicle screw and rod systems).

Indications for use as stated in the FDA summary.

Also cleared against K152156

1 other device cites the same predicate.

  • K171425Concorde LiftMedos International SARL · 20172 recalls

More from Interventional Spine, Inc.

8 FDA decisions under this applicant name. See the company

  • K152156Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc. · 20152 recalls
  • K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc. · 2014
  • K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc. · 2014
  • K132479Opticage Interbody Fusion Device, Model 9080-00Interventional Spine, Inc. · 2013
  • K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc. · 2012

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K160464 · printed Nov 4, 2026

Cite this page

510(k) Report. “K160464: Opticage (R) Expandable Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160464

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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