510(k) Report

510(k) · Cleared

Cleared

Interform Interbody Cage System

K131082510(k) TraditionalCleared Aug 26, 2013130-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

Next Orthosurgical · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Aug 26, 2013 as substantially equivalent to K071724 (Spinal Elements, Inc., 2007) and 14 other predicates after a 130-day review. Its family tree reaches back 10 generations to 1984. 1 of the 650 devices in its family, counting itself, has a Class I recall. 595 later devices descend from it.

Decided
Aug 26, 2013
Review
130 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
15

Its longest line of descent runs back 10 generations to K841189 (1984). 54 ancestors in all. 595 later devices descend from it, 3 citing it directly. 1 of the 650 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2010: 4 other ancestors2009: 2 other ancestors2008: 3 other ancestors2007: 6 other ancestors2002: 6 other ancestors1999: 2 other ancestors2005: 2 other ancestors2001: 8 other ancestors1996: 2 other ancestors2004: 6 other ancestors2000: 1 other ancestor2003: 2 other ancestors2017: 29 descendants cleared2015: 8 descendants cleared2016: 17 descendants cleared2018: 31 descendants cleared2020: 64 descendants cleared2021: 51 descendants cleared, 1 with a Class I recall12019: 44 descendants cleared2023: 76 descendants cleared2025: 73 descendants cleared2024: 83 descendants cleared2022: 61 descendants cleared2026: 58 descendants clearedK841189 · 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. · 2007K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 200819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 14 other ancestors2 generations back: 10 other ancestors3 generations back: 8 other ancestors4 generations back: 5 other ancestors5 generations back: 5 other ancestors6 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 25 descendants3 generations forward: 82 descendants4 generations forward: 127 descendants, 1 with a Class I recall15 generations forward: 163 descendants6 generations forward: 106 descendants7 generations forward: 57 descendants8 generations forward: 23 descendants9 generations forward: 7 descendants10 generations forward: 2 descendants K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · 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+5+10
  1. Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 6 generations between
  3. 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  4. 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  5. 1 generation backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  6. This deviceK131082 Interform Interbody Cage SystemNext Orthosurgical · 2013
  7. Descendant · cites it directly · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
  8. Descendant · 2 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
  9. Descendant · 2 generations on · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
  10. Descendant · 3 generations on · 400 of its ownK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
  11. Descendant · 4 generations on · 396 of its ownK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
Show all 10 generations
  1. Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 5 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 4 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 1 generation backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. This deviceK131082 Interform Interbody Cage SystemNext Orthosurgical · 2013

Showing 5 of 595 descendants. See all descendants

Descendants cleared per year

2015: 82016: 172017: 292018: 312019: 442020: 642021: 512022: 612023: 762024: 832025: 732026: 58
2015high 83 (2024) · low 8 (2015)2026

Class I recalls in this family

  • K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 595 · See all
  • K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · cites it directly588descendants
  • K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 2 generations on479descendants
  • K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015 · 2 generations on402descendants
  • K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016 · 3 generations on400descendants
  • K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016 · 4 generations on396descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−9K990148Stackable Cage SystemDepuy Motech Acromed1999—
−8K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−7K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−6K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−5K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−4K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−3K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−2K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−1K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
0 (this device)K131082Interform Interbody Cage SystemNext Orthosurgical2013—
+1K141665NuVasive CoRoent SystemNuvasive, Inc.2015—
+2K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015—
+2K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015—
+3K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016—
+4K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
200180
200260
200320
200460
200520
200760
200830
200920
201040

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201580
2016170
2017290
2018310
2019440
2020640
2021511
2022610
2023760
2024830
2025730
2026580
FIG. 1 — Lineage of K131082, 1984–2026Source: 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.

1 device in this family has a Class I recall. 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? (15)

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
*K071724Lucent
Summary page 1
…CIFR section: 21 CFR section 888.3080 Device panel: Orthopedic Legally Marketed Spinal Elements, Lucent Straight Interbody Cage (K0717241KO81 968) Predicate Device: DePuy, Brantigan I/F CAGE (P960025) SEASPINE, Pacifica Cage…
Spinal Elements, Inc.2007—
*K081968Modification to LucentSpinal Elements, Inc.2008—
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 1
…anel: Orthopedic Legally Marketed Spinal Elements, Lucent Straight Interbody Cage (K0717241KO81 968) Predicate Device: DePuy, Brantigan I/F CAGE (P960025) SEASPINE, Pacifica Cage (K082310) DiFusion Technologies, XIPHOS Inte…
Depuy Spine, Inc.1999—
*K082310Hollywood, Pacifica, Redondo, Ventura
Summary page 1
…ucent Straight Interbody Cage (K0717241KO81 968) Predicate Device: DePuy, Brantigan I/F CAGE (P960025) SEASPINE, Pacifica Cage (K082310) DiFusion Technologies, XIPHOS Interbody Fusion System (K100042) Synt…
Seaspine, Inc.2008—
*K100042Difusion Technologies Xiphos Interbody Fusion System
Summary page 1
…n I/F CAGE (P960025) SEASPINE, Pacifica Cage (K082310) DiFusion Technologies, XIPHOS Interbody Fusion System (K100042) Synthes T-PAL (K1 00089) Nuvasive CoRoent XL (K071795/ K08161 1)…
Difusion Technologies2010—
*K100089Synthes T-Pal Spacer
Summary page 1
…SPINE, Pacifica Cage (K082310) DiFusion Technologies, XIPHOS Interbody Fusion System (K100042) Synthes T-PAL (K1 00089) Nuvasive CoRoent XL (K071795/ K08161 1) Medtronic Capstone (K073291)…
Synthes Spine20101
*K071795Nuvasive Coroent System
Summary page 1
…DiFusion Technologies, XIPHOS Interbody Fusion System (K100042) Synthes T-PAL (K1 00089) Nuvasive CoRoent XL (K071795/ K08161 1) Medtronic Capstone (K073291) Synthes OPAL (K072791)…
Nuvasive, Inc.2007—
*K081611Nuvasive Coroent System
Summary page 1
…Technologies, XIPHOS Interbody Fusion System (K100042) Synthes T-PAL (K1 00089) Nuvasive CoRoent XL (K071795/ K08161 1) Medtronic Capstone (K073291) Synthes OPAL (K072791)…
Nuvasive, Inc.2008—
*K073291Capstone Spinal System
Summary page 1
…Synthes T-PAL (K1 00089) Nuvasive CoRoent XL (K071795/ K08161 1) Medtronic Capstone (K073291) Synthes OPAL (K072791) GS Medical ANYPLUS (K1 00516)…
Medtronic Sofamor Danek USA, Inc.2008—
*K072791Oracle Spacer, Opal Spacer
Summary page 1
…Nuvasive CoRoent XL (K071795/ K08161 1) Medtronic Capstone (K073291) Synthes OPAL (K072791) GS Medical ANYPLUS (K1 00516) Medtronic Boomerang (K023570)…
Synthes Spine20071
*K100516Anyplus Peek Cages
Summary page 1
…8161 1) Medtronic Capstone (K073291) Synthes OPAL (K072791) GS Medical ANYPLUS (K1 00516) Medtronic Boomerang (K023570) Synthes Oracle (K062933)…
GS Medical Co., Ltd.2010—
*K023570Modification to Verte-Stack Spinal System
Summary page 1
…3291) Synthes OPAL (K072791) GS Medical ANYPLUS (K1 00516) Medtronic Boomerang (K023570) Synthes Oracle (K062933) Spinal USA ShurFit (K092193)…
Medtronic Sofamor Danek2002—
*K062933Synthes Oracle Spacer
Summary page 1
…91) GS Medical ANYPLUS (K1 00516) Medtronic Boomerang (K023570) Synthes Oracle (K062933) Spinal USA ShurFit (K092193) Amedica Valec (K091278)…
Synthes Spine Co.Lp2007—
*K092193Spinal Usa Interbody Cages
Summary page 1
…516) Medtronic Boomerang (K023570) Synthes Oracle (K062933) Spinal USA ShurFit (K092193) Amedica Valec (K091278) Submitter: Next OrthoSurgical…
Spinal USA2009—
*K091278Valeo Spacer System
Summary page 1
…(K023570) Synthes Oracle (K062933) Spinal USA ShurFit (K092193) Amedica Valec (K091278) Submitter: Next OrthoSurgical 3270 Corporate View, Suite A…
Amedica Corp.2010—

Also cleared against K071724: 38 other devices →

What descends from it? (595)

See all 595

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141665NuVasive CoRoent SystemNuvasive, Inc.2015588
K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731
K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 29 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
  • 8 of the 54 ancestors have a recall of any class.
  • Of its descendants, K141665 (Nuvasive, Inc., 2015) has gone furthest, with 588 descendants of its own.
  • 38 other devices also cite its predicate K071724.

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. 2013, 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?

When used as an intervertebral body fusion device, the lnterFornm Lumbar Interbody Cage System is intended for spinal fusion procedures at one or two contiguous levels ([2-Si) in skeletally mature patients with degenerative disc disease (DOD). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DOD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at…

Read the full statement (135 words)

When used as an intervertebral body fusion device, the lnterFornm Lumbar Interbody Cage System is intended for spinal fusion procedures at one or two contiguous levels ([2-Si) in skeletally mature patients with degenerative disc disease (DOD). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DOD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Lumbar Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Indications for use as stated in the FDA summary.

Also cleared against K071724

38 other devices cite the same predicate.

  • K253260ORIO-3D Cage SystemSpineCraft · 2026
  • K234150Lucent® XPSpinal Elements · 2024
  • K223335SIRION Lateral Lumbar Interbody SystemAstura Medical · 2023
  • K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal…Spinal Elements, Inc. · 2021
  • K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc. · 2020
  • K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC · 2019

More from Next Orthosurgical

6 FDA decisions under this applicant name. See the company

  • K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical · 2024
  • K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical · 2020
  • K161608InterForm Cervical Interbody Cage SystemNext Orthosurgical · 2016
  • K161499VertiForm Posterior Fixation SystemNext Orthosurgical · 2016
  • K141291Vertiform Posterior Fixation SystemNext Orthosurgical · 2014

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/K131082 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131082: Interform Interbody Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131082

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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