510(k) Report

510(k) · Cleared

Cleared

Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage

K111820510(k) TraditionalCleared Mar 14, 2012260-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

Bm Korea Co., Ltd. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Mar 14, 2012 as substantially equivalent to K090064 (Eminent Spine, 2009) and 12 other predicates after a 260-day review. Its family tree reaches back 11 generations to 2001. 20 later devices descend from it.

Decided
Mar 14, 2012
Review
260 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
13

Its longest line of descent runs back 11 generations to K003155 (2001). 68 ancestors in all, the oldest K841189 (1984). 20 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 3 other ancestors2009: 7 other ancestors2002: 5 other ancestors2001: 8 other ancestors1999: 3 other ancestors1996: 2 other ancestors2008: 4 other ancestors2007: 4 other ancestors2005: 5 other ancestors2004: 9 other ancestors2003: 5 other ancestors1984: 1 other ancestor2000: 1 other ancestor2013: 2 descendants cleared2019: 3 descendants cleared2014: 3 descendants cleared2017: 3 descendants cleared2022: 3 descendants cleared2021: 2 descendants cleared2025: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant cleared2024: 1 descendant clearedK003155 · 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 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 12 other ancestors2 generations back: 9 other ancestors3 generations back: 12 other ancestors4 generations back: 12 other ancestors5 generations back: 9 other ancestors6 generations back: 2 other ancestors7 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 7 descendants4 generations forward: 2 descendants 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 deviceK111820 Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd. · 2012
  7. Descendant · cites it directly · 16 of its ownK122872 Intervertebral Body Fusion DeviceDio Medical Co., Ltd. · 2013
  8. Descendant · 2 generations on · 10 of its ownK132926 Velofixtm Interbody Fusion SystemU&I Corp. · 2014
  9. Descendant · 2 generations on · 9 of its ownK140864 Veloxtm Interbody Fusion SystemU&I Corp. · 2014
  10. Descendant · 2 generations on · 5 of its ownK172424 Velofix™ SA Cervical CageU&I Corporation · 2017 · Recalled
  11. Descendant · 3 generations on · 5 of its ownK171749 Velofix (tm) Interbody Fusion SystemU&I Corporation · 2017
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 deviceK111820 Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd. · 2012

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2013: 22014: 32017: 32018: 12019: 32021: 22022: 32024: 12025: 12026: 1
2013high 3 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 20 · See all
  • K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd. · 2013 · cites it directly16descendants
  • K132926Velofixtm Interbody Fusion SystemU&I Corp. · 2014 · 2 generations on10descendants
  • K140864Veloxtm Interbody Fusion SystemU&I Corp. · 2014 · 2 generations on9descendants
  • K172424Velofix™ SA Cervical CageU&I Corporation · 2017 · 2 generations on5descendants
  • K171749Velofix (tm) Interbody Fusion SystemU&I Corporation · 2017 · 3 generations on5descendants
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)K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.2012—
+1K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.2013—
+2K132926Velofixtm Interbody Fusion SystemU&I Corp.2014—
+2K140864Veloxtm Interbody Fusion SystemU&I Corp.2014—
+2K172424Velofix™ SA Cervical CageU&I Corporation20171
+3K171749Velofix (tm) Interbody Fusion SystemU&I Corporation2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199620
199930
200010
200180
200250
200350
200490
200550
200740
200840
200970
201030

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201430
201730
201810
201930
202120
202230
202410
202510
202610
FIG. 1 — Lineage of K111820, 2001–2026Source: 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.

Planning a device in ODP? 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 ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (13)

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
*K090064Eminent Spine Interbody Fusion System
Summary page 1
…perational principle and material composition when compared to the predicate devices cleared under the following: Eminent Spine Interbody Fusion System (K090064) Genesys Spine Interbody Fusion System (K 103034) BM KOREA CO., LTD…
Eminent Spine20091
*K103034Genesys Spine Interbody Fusion System
Summary page 1
…ed to the predicate devices cleared under the following: Eminent Spine Interbody Fusion System (K090064) Genesys Spine Interbody Fusion System (K 103034) BM KOREA CO., LTD Page 1/3…
Genesys Spine20101
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 2
…K111820 " 0 BMK"Page 2 of 3 BAK/Cervical Interbody Fusion System (P980048) Affinity Anterior Cervical Cage System (P000028) RAY Threaded Fusion Cage (P950019) Lumbar lIP Cage (P96002…
Sulzer Spine-Tech2001—
*P000028Affinity (TM) Cage System
Summary page 2
…BMK"Page 2 of 3 BAK/Cervical Interbody Fusion System (P980048) Affinity Anterior Cervical Cage System (P000028) RAY Threaded Fusion Cage (P950019) Lumbar lIP Cage (P960025) INTERPIX Threaded Fusion Device (P97001 5)…
Medtronic Sofamor Danek USA, Inc.2002—
*P950019Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation
Summary page 2
…2 of 3 BAK/Cervical Interbody Fusion System (P980048) Affinity Anterior Cervical Cage System (P000028) RAY Threaded Fusion Cage (P950019) Lumbar lIP Cage (P960025) INTERPIX Threaded Fusion Device (P97001 5) RABEA TMSpinal Implant (K082848)…
Stryker Spine19961
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 2
…BAK/Cervical Interbody Fusion System (P980048) Affinity Anterior Cervical Cage System (P000028) RAY Threaded Fusion Cage (P950019) Lumbar lIP Cage (P960025) INTERPIX Threaded Fusion Device (P97001 5) RABEA TMSpinal Implant (K082848) Aesculap PEEK Spinal Implant Sy…
Depuy Spine, Inc.1999—
*P970015Inter Fix Threaded Fusion Device
Summary page 2
…Affinity Anterior Cervical Cage System (P000028) RAY Threaded Fusion Cage (P950019) Lumbar lIP Cage (P960025) INTERPIX Threaded Fusion Device (P97001 5) RABEA TMSpinal Implant (K082848) Aesculap PEEK Spinal Implant System (K07 1983) Stryker Spine AVS® TL PEEK…
Sofamor Danek19991
*K082848Nubic and Rabea Devices
Summary page 2
…tem (P000028) RAY Threaded Fusion Cage (P950019) Lumbar lIP Cage (P960025) INTERPIX Threaded Fusion Device (P97001 5) RABEA TMSpinal Implant (K082848) Aesculap PEEK Spinal Implant System (K07 1983) Stryker Spine AVS® TL PEEK Spacers (K083661) Synthes T-PAL S…
Signus Medizintechnik GmbH2009—
*K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space
Summary page 2
…9) Lumbar lIP Cage (P960025) INTERPIX Threaded Fusion Device (P97001 5) RABEA TMSpinal Implant (K082848) Aesculap PEEK Spinal Implant System (K07 1983) Stryker Spine AVS® TL PEEK Spacers (K083661) Synthes T-PAL Spacer (K 100089) AVS® PL PEEK Spacers (K093704)…
Aesculap Implant Systems, Inc.20081
*K083661Avs TL Peek Spacers
Summary page 2
…hreaded Fusion Device (P97001 5) RABEA TMSpinal Implant (K082848) Aesculap PEEK Spinal Implant System (K07 1983) Stryker Spine AVS® TL PEEK Spacers (K083661) Synthes T-PAL Spacer (K 100089) AVS® PL PEEK Spacers (K093704) AnyPlus ALIF, PLIF, TLIF PEEK Lumbar Cage (K…
Stryker Corp.2009—
*K100089Synthes T-Pal Spacer
Summary page 2
…RABEA TMSpinal Implant (K082848) Aesculap PEEK Spinal Implant System (K07 1983) Stryker Spine AVS® TL PEEK Spacers (K083661) Synthes T-PAL Spacer (K 100089) AVS® PL PEEK Spacers (K093704) AnyPlus ALIF, PLIF, TLIF PEEK Lumbar Cage (K 100516) 4. Device Description:…
Synthes Spine20101
*K093704Avs PL Peek Spacers
Summary page 2
…Aesculap PEEK Spinal Implant System (K07 1983) Stryker Spine AVS® TL PEEK Spacers (K083661) Synthes T-PAL Spacer (K 100089) AVS® PL PEEK Spacers (K093704) AnyPlus ALIF, PLIF, TLIF PEEK Lumbar Cage (K 100516) 4. Device Description: The SYNSTER® (CERVICAL, ALIF, PLIF,…
Stryker Corp.2009—
*K100516Anyplus Peek Cages
Summary page 2
…ryker Spine AVS® TL PEEK Spacers (K083661) Synthes T-PAL Spacer (K 100089) AVS® PL PEEK Spacers (K093704) AnyPlus ALIF, PLIF, TLIF PEEK Lumbar Cage (K 100516) 4. Device Description: The SYNSTER® (CERVICAL, ALIF, PLIF, PTLLF and TLLP) CAGE will be offered in various devic…
GS Medical Co., Ltd.2010—

Also cleared against K090064: 33 other devices →

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316
K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133
K1803473d CageFims Co., Ltd.20190
K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140

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 11 years and passes through 6 companies; a new generation was cleared every 9 months on median.
  • 11 of the 68 ancestors have a recall of any class.
  • Of its descendants, K122872 (Dio Medical Co., Ltd., 2013) has gone furthest, with 16 descendants of its own.
  • 33 other devices also cite its predicate K090064.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

The SYNSTER CERVICAL CAGE is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DOD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to…

Read the full statement (187 words)

The SYNSTER CERVICAL CAGE is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DOD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The SYNSTER (ALIF, PLIF, PTLIE and TLIF) CAGE is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (ODD) with up to Grade I spondylolisthesis. ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Indications for use as stated in the FDA summary.

Also cleared against K090064

33 other devices cite the same predicate.

  • K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC · 2023
  • K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine · 2023
  • K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC · 2019
  • K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC · 2019
  • K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC · 20181 recall
  • K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc. · 2018

More from Bm Korea Co., Ltd.

5 FDA decisions under this applicant name. See the company

  • K143006GUARDIAN-SG Inflatable Bone Expander SystemBm Korea Co., Ltd. · 2015
  • K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage Talon Tifa CageBm Korea Co., Ltd. · 2013
  • K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd. · 2012
  • K111593Guardian Inflatable Bone Expander SystemBm Korea Co., Ltd. · 2011

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K111820 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111820: Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111820

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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