510(k) Report

510(k) · Cleared

Cleared

Peek Cage for the Vertebral Spine

K132852510(k) TraditionalCleared May 29, 2014260-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

Neoortho Produtos Ortopedicos S/A · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on May 29, 2014 as substantially equivalent to K071983 (Aesculap Implant Systems, Inc., 2008) and 1 other predicate after a 260-day review. Its family tree reaches back 11 generations to 2001.

Decided
May 29, 2014
Review
260 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
2

Its longest line of descent runs back 11 generations to K003155 (2001). 39 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor2007: 2 other ancestors2005: 3 other ancestors2004: 5 other ancestors2003: 5 other ancestors2002: 3 other ancestors2001: 6 other ancestors1999: 1 other ancestor1984: 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 · recalled19801985199019952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 6 other ancestors4 generations back: 7 other ancestors5 generations back: 6 other ancestors6 generations back: 4 other ancestors7 generations back: 2 other ancestors K071983 · 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 · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 7 generations between
  3. 3 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  4. 2 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
  5. 1 generation backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
  6. This deviceK132852 Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A · 2014
Show all 11 generations
  1. Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 10 generations backK012254 VBROsteotech, Inc. · 2001
  3. 9 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 8 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 7 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 6 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. 5 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. 4 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. 3 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  10. 2 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
  11. 1 generation backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
  12. This deviceK132852 Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−10K012254VBROsteotech, Inc.2001—
−9K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−8K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−7K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−6K040731Stryker Spine Vertebral SpacerStryker Spine2004—
−5K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
−4K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
−3K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005—
−2K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006—
−1K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace…Aesculap Implant Systems, Inc.20081
0 (this device)K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199910
200010
200160
200230
200350
200450
200530
200720
200910
FIG. 1 — Lineage of K132852, 2001–2014Source: 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
*K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space
Summary page 1
…88.3060 ODP- 21 CFR §888.3080 Classification Panel Orthopedic Predicate Device Identification K071983 Aesculap PEEK Spinal Implant System; K082848 Nubic by Signus Device Description The…
Aesculap Implant Systems, Inc.20081
*K082848Nubic and Rabea Devices
Summary page 1
…Panel Orthopedic Predicate Device Identification K071983 Aesculap PEEK Spinal Implant System; K082848 Nubic by Signus Device Description The PEEK CAGE FOR THE VERTEBRAL SPINE NEOSPACE is an intervertebral body fusion device that…
Signus Medizintechnik GmbH2009—

Also cleared against K071983: 11 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 13 years and passes through 6 companies; a new generation was cleared every 9 months on median.
  • 3 of the 39 ancestors have a recall of any class.
  • 11 other devices also cite its predicate K071983.

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. 2014, 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 PEEK Cage for the Vertebral Spine NeoSpace PLIF, TLIF, and AUIF devices are indicated for spinal fusion procedures at one or two contiguous levels from L2-S 1, in skeletally mature patients with degenerative disc disease (ODD). DDD is defined as back pain of discogenic origin with degeneration of the disc conifirmed by history and radiographic studies. DDID patients may also have Grade I Spondylolisthesis or retrolisthesis at involved levels.…

Read the full statement (218 words)

The PEEK Cage for the Vertebral Spine NeoSpace PLIF, TLIF, and AUIF devices are indicated for spinal fusion procedures at one or two contiguous levels from L2-S 1, in skeletally mature patients with degenerative disc disease (ODD). DDD is defined as back pain of discogenic origin with degeneration of the disc conifirmed by history and radiographic studies. DDID patients may also have Grade I Spondylolisthesis or retrolisthesis at involved levels. Patients must have undergone a regimen of six months of non-operative treatment prior to treatment in the lumbar spine. The PUPF devices may be used singularly or in pairs. All lumbar devices are to be used with supplemental fixation cleared for use in the lumbar spine.

The Cervical devices are indicated for spinal fusion procedures at one level in the cervical spine from C3 to TI for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of tihe disc confirmed by history and radiographic studies). Patients must have undergone a regimen of six weeks of non-operative treatment prior to treatment in the cervical spine. One cervical device is used per intervertebral space. All cervical devices are to be used with supplemental fixation cleared for use in the cervical spine.

All lumbar and cervical devices are intended for use with autogenous bone graft.

Indications for use as stated in the FDA summary.

Also cleared against K071983

11 other devices cite the same predicate.

  • K181899Roccia® PlifSilony Medical GmbH · 2018
  • K181970MectaLIF Posterior ExtensionMedacta International S.A. · 2018
  • K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC · 2017
  • K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH · 2015
  • K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC · 2015
  • K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc. · 2014

More from Neoortho Produtos Ortopedicos S/A

5 FDA decisions under this applicant name. See the company

  • K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A · 2017
  • K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A · 2014
  • K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012
  • K102641Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A · 2010

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/K132852 · printed Nov 4, 2026

Cite this page

510(k) Report. “K132852: Peek Cage for the Vertebral Spine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132852

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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