510(k) Report

510(k) · Cleared

Cleared

Plif Lite and Tlif Lite

K132907510(k) TraditionalCleared Jul 24, 2014310-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

Sintea Plustek · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Jul 24, 2014 as substantially equivalent to P950019 (Stryker Spine, 1996) and 3 other predicates after a 310-day review. Its family tree reaches back 6 generations to 2001.

Decided
Jul 24, 2014
Review
310 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K003155 (2001). 24 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor1999: 2 other ancestors1996: 2 other ancestors2009: 1 other ancestor2004: 2 other ancestors2002: 3 other ancestors2003: 1 other ancestor2001: 4 other ancestors2000: 1 other ancestor1984: 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 · 2003K042714 · Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4 · Spine Next America Corporation · 200419801985199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors3 generations back: 2 other ancestors4 generations back: 8 other ancestors5 generations back: 1 other ancestor K042714 · Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4 · Spine Next America Corporation · 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. · 2001−50
  1. Root · 6 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 5 generations backK012254 VBROsteotech, Inc. · 2001
  3. 4 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 3 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 2 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 1 generation backK042714 Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation · 2004
  7. This deviceK132907 Plif Lite and Tlif LiteSintea Plustek · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−5K012254VBROsteotech, Inc.2001—
−4K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−3K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−2K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−1K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation2004—
0 (this device)K132907Plif Lite and Tlif LiteSintea Plustek2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199620
199920
200010
200140
200230
200310
200420
200910
201010
FIG. 1 — Lineage of K132907, 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? (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
*P950019Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation
Summary page 1
…terbody Fusion system is substantially equivalent to legally marketed predicate devices. The predicate devices are the Stryker (formerly Surgical Dynamics) Ray TFC Cage (P950019a), the Depuy Spine Lumbar I/F Cage Implant System (P960025), the Zimmer (formerly Spinal Concept) Fidji PEEK Lumbar Cage (K042714…
Stryker Spine19961
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 1
…y marketed predicate devices. The predicate devices are the Stryker (formerly Surgical Dynamics) Ray TFC Cage (P950019a), the Depuy Spine Lumbar I/F Cage Implant System (P960025), the Zimmer (formerly Spinal Concept) Fidji PEEK Lumbar Cage (K042714) and the RTree Innovations Epicage (K092901). Intended Us…
Depuy Spine, Inc.1999—
*K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4
Summary page 1
…rmerly Surgical Dynamics) Ray TFC Cage (P950019a), the Depuy Spine Lumbar I/F Cage Implant System (P960025), the Zimmer (formerly Spinal Concept) Fidji PEEK Lumbar Cage (K042714) and the RTree Innovations Epicage (K092901). Intended Use / Indications for Use The PLIF Lite and TLIF Lite Lumbar Interbody Fu…
Spine Next America Corporation2004—
*K092901Epicage Interbody Fusion Device
Summary page 1
…019a), the Depuy Spine Lumbar I/F Cage Implant System (P960025), the Zimmer (formerly Spinal Concept) Fidji PEEK Lumbar Cage (K042714) and the RTree Innovations Epicage (K092901). Intended Use / Indications for Use The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are indicated for intervertebra…
R Tree Innovations2010—

Also cleared against P950019: 37 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 4 companies; a new generation was cleared every 10 months on median.
  • 3 of the 24 ancestors have a recall of any class.
  • 37 other devices also cite its predicate P950019.

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 PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally…

Read the full statement (119 words)

The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are designed for use with autograft bone to facilitate fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Indications for use as stated in the FDA summary.

Also cleared against P950019

37 other devices cite the same predicate.

  • K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC · 2017
  • K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc. · 20161 recall
  • K152512Half Dome Posterior Lumbar Interbody SystemAstura Medical · 2016
  • K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI…Osteomed Implantes, Ltda · 2015
  • K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies · 2015
  • K141980Leva (TM) Spacer SystemSpine Wave, Inc. · 2015

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/K132907 · printed Nov 4, 2026

Cite this page

510(k) Report. “K132907: Plif Lite and Tlif Lite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132907

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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