510(k) Report

510(k) · Cleared

Cleared

Pantheon Spinal Pontus Interbody Fusion Device

K181548510(k) TraditionalCleared Dec 16, 2019552-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

Pantheon Spinal · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Dec 16, 2019 as substantially equivalent to K113781 (Pantheon Spinal, 2013) and 1 other predicate after a 552-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it.

Decided
Dec 16, 2019
Review
552 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K113781 (2013). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2017: 1 other ancestor2021: 1 descendant clearedK113781 · Pantheon Spinal Ibfd System · Pantheon Spinal · 20132010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant K113781 · Pantheon Spinal Ibfd System · Pantheon Spinal · 20130
  1. Root · 1 generation backK113781 Pantheon Spinal Ibfd SystemPantheon Spinal · 2013
  2. This deviceK181548 Pantheon Spinal Pontus Interbody Fusion DevicePantheon Spinal · 2019
  3. Descendant · cites it directly · 0 of its ownK203003 Pantheon IBFDPantheon Spinal · 2021

Most influential descendants

Showing 1 of 1 · See all
  • K203003Pantheon IBFDPantheon Spinal · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K113781Pantheon Spinal Ibfd SystemPantheon Spinal2013—
0 (this device)K181548Pantheon Spinal Pontus Interbody Fusion DevicePantheon Spinal2019—
+1K203003Pantheon IBFDPantheon Spinal2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
FIG. 1 — Lineage of K181548, 2013–2021Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K113781Pantheon Spinal Ibfd System
Summary page 5
…for Surgical Implant Applications (UNS R05200, UNS R05400) and a hub of Titanium Alloy Ti-6AL-4V Primary Predicate Device: The Pantheon Spinal Interbody Fusion Device (K113781) Additional Predicate Devices Summit Spine Yellowstone Lumbar Interbody Fusion System ( K170572) Technological Characteristics…
Pantheon Spinal2013—
*K170572Summit Spine Yellowstone Lumbar Interbody Fusion System
Summary page 5
…Primary Predicate Device: The Pantheon Spinal Interbody Fusion Device (K113781) Additional Predicate Devices Summit Spine Yellowstone Lumbar Interbody Fusion System ( K170572) Technological Characteristics The Pantheon Spinal Interbody Fusion System possesses the same technological characteristcs as t…
Summit Spine2017—

Also cleared against K113781: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K203003Pantheon IBFDPantheon Spinal20210

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K203003 (Pantheon Spinal, 2021) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K113781.

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. 2019, 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 Pantheon Spinal Pontus Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. Pantheon Spinal Pontus Interbody Fusion Device is designed for use with autogenous bone graft to facilitate fusion. Pantheon Spinal Pontus Interbody Fusion Device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD)…

Read the full statement (165 words)

The Pantheon Spinal Pontus Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. Pantheon Spinal Pontus Interbody Fusion Device is designed for use with autogenous bone graft to facilitate fusion. Pantheon Spinal Pontus Interbody Fusion Device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. Pantheon Spinal Pontus Interbody Fusion Device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and lateral.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K113781

1 other device cites the same predicate.

  • K203003Pantheon IBFDPantheon Spinal · 2021

More from Pantheon Spinal

4 FDA decisions under this applicant name. See the company

  • K241494Pantheon Pedicle Screw and Iliac Bolt Fixation SystemPantheon Spinal · 2024
  • K203003Pantheon IBFDPantheon Spinal · 2021
  • K113781Pantheon Spinal Ibfd SystemPantheon Spinal · 2013

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/K181548 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181548: Pantheon Spinal Pontus Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181548

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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