510(k) Report

510(k) · Cleared

Cleared

SurgTech Interbody System

K152200510(k) TraditionalCleared Mar 25, 2016232-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

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

Cleared on Mar 25, 2016 as substantially equivalent to K113478 (Eisertech, LLC, 2012) and 3 other predicates after a 232-day review. Its family tree reaches back 12 generations to 2001.

Decided
Mar 25, 2016
Review
232 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
4

Its longest line of descent runs back 12 generations to K003155 (2001). 59 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor2008: 4 other ancestors2007: 7 other ancestors1999: 3 other ancestors1996: 2 other ancestors2005: 4 other ancestors2004: 9 other ancestors2003: 5 other ancestors2002: 4 other ancestors2001: 6 other ancestors1984: 1 other ancestor2000: 1 other ancestorK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×2: 2 generations cleared close together, K021791 (2002), K023570 (2002) K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004×2: 2 generations cleared close together, K042571 (2005), K050624 (2005) K051205 · Stryker Spine Avs Asl Peek Spacer · Stryker Spine · 2005K060762 · Aesculap Peek Vertebral Body Replacement System · Aesculap, Inc. · 2006K071983 · Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space · Aesculap Implant Systems, Inc. · 2008 · recalledK113478 · Plif Cage · Eisertech, LLC · 20121980199020002010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 6 other ancestors3 generations back: 6 other ancestors4 generations back: 9 other ancestors5 generations back: 9 other ancestors6 generations back: 8 other ancestors7 generations back: 6 other ancestors K113478 · Plif Cage · Eisertech, LLC · 2012K071983 · Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space · Aesculap Implant Systems, Inc. · 2008 · recalledK060762 · Aesculap Peek Vertebral Body Replacement System · Aesculap, Inc. · 2006K051205 · Stryker Spine Avs Asl Peek Spacer · Stryker Spine · 2005K050624 · Stryker Spine Avs PL Peek Spacer · Stryker Spine · 2005K042571 · Stryker Spine Avs TL Peek Spacer · Stryker Spine · 2005K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−10−50
  1. Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 8 generations between
  3. 3 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
  4. 2 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
  5. 1 generation backK113478 Plif CageEisertech, LLC · 2012
  6. This deviceK152200 SurgTech Interbody SystemSurgtech, Inc. · 2016
Show all 12 generations
  1. Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 11 generations backK012254 VBROsteotech, Inc. · 2001
  3. 10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 8 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 7 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. 6 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. 5 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. 4 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  10. 3 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
  11. 2 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
  12. 1 generation backK113478 Plif CageEisertech, LLC · 2012
  13. This deviceK152200 SurgTech Interbody SystemSurgtech, Inc. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−11K012254VBROsteotech, Inc.2001—
−10K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−9K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−8K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−7K040731Stryker Spine Vertebral SpacerStryker Spine2004—
−6K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
−5K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
−4K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005—
−3K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006—
−2K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace…Aesculap Implant Systems, Inc.20081
−1K113478Plif CageEisertech, LLC2012—
0 (this device)K152200SurgTech Interbody SystemSurgtech, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199620
199930
200010
200160
200240
200350
200490
200540
200770
200840
200910
FIG. 1 — Lineage of K152200, 2001–2016Source: 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 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? (4)

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
*K113478Plif Cage
Summary page 4
…T1 (polyetheretherketone) per ASTM F2026 and contain tantalum radiopaque markers per ASTM F560. Primary Predicate: PLIF Cage (Eisertech LLC, K113478) Additional Predicate: AVS® PL PEEK Spacers (Stryker Spine – K073470, K082014 & K093704) Performance Data: Mechanical tes…
Eisertech, LLC2012—
*K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXX
Summary page 4
…radiopaque markers per ASTM F560. Primary Predicate: PLIF Cage (Eisertech LLC, K113478) Additional Predicate: AVS® PL PEEK Spacers (Stryker Spine – K073470, K082014 & K093704) Performance Data: Mechanical testing of the worst case SurgTech Interbody System device…
Stryker Spine2008—
*K082014Stryker Spine Avs PL Peek Spacers
Summary page 4
…radiopaque markers per ASTM F560. Primary Predicate: PLIF Cage (Eisertech LLC, K113478) Additional Predicate: AVS® PL PEEK Spacers (Stryker Spine – K073470, K082014 & K093704) Performance Data: Mechanical testing of the worst case SurgTech Interbody System device…
Stryker Corp.2008—
*K093704Avs PL Peek Spacers
Summary page 4
…opaque markers per ASTM F560. Primary Predicate: PLIF Cage (Eisertech LLC, K113478) Additional Predicate: AVS® PL PEEK Spacers (Stryker Spine – K073470, K082014 & K093704) Performance Data: Mechanical testing of the worst case SurgTech Interbody System device was perfor…
Stryker Corp.2009—

Also cleared against K113478: 7 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 15 years and passes through 7 companies; a new generation was cleared every 10 months on median.
  • 7 of the 59 ancestors have a recall of any class.
  • 7 other devices also cite its predicate K113478.

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 SurgTech Interbody System is indicated for use with autogenous bone graft in skeletally mature patients with

degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain

with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of

non-operative treatment. These patients may have had a previous non-fusion spinal surgery and may also have up to

Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). These devices are intended to be used with

supplemental fixation which has been cleared for use in the lumbar spine.

Indications for use as stated in the FDA summary.

Also cleared against K113478

7 other devices cite the same predicate.

  • K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc. · 2017
  • K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine · 2017
  • K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC · 2016
  • K153356Spine Innovation Interbody SystemSpine Innovation, LLC · 2016
  • K140348Interbody CageEisertech, LLC · 2015
  • K132738Cogent Med-LifCogent Spine, LLC · 2014

More from Surgtech, Inc.

6 FDA decisions under this applicant name. See the company

  • K191192SurgTech GENOLL Total Knee SystemSurgtech, Inc. · 2019
  • K173455SurgTech Bipolar Head SystemSurgtech, Inc. · 2018
  • K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc. · 2017
  • K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc. · 2017
  • K161894SurgTech Trauma SystemSurgtech, Inc. · 2017

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/K152200 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152200: SurgTech Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152200

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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