510(k) · Cleared
ClearedKONG-TL VBR System, KONG-C VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icotec AG · MQP Spinal Vertebral Body Replacement Device
Cleared on May 29, 2020 as substantially equivalent to K191778 (Omnia Medical, LLC, 2019) and 6 other predicates after a 120-day review. Its family tree reaches back 23 generations to 1984. 1 of the 320 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- May 29, 2020
- Review
- 120 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 23 generations to K841189 (1984). 318 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 320 devices in this family, counting this one, has a Class I recall.
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations between
- 3 generations backK170055 CAPRI Corpectomy Cage SystemK2m · 2017
- 2 generations backK171704 CAPRI Corpectomy Cage SystemK2m · 2017
- 1 generation backK180665 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018
- This deviceK200235 KONG-TL VBR System, KONG-C VBR SystemIcotec AG · 2020
- Descendant · cites it directly · 0 of its ownK232790 KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024
Show all 23 generations
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 21 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 20 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 17 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 16 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 13 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 12 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 11 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 10 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 9 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 8 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 7 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 6 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 5 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 4 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 3 generations backK170055 CAPRI Corpectomy Cage SystemK2m · 2017
- 2 generations backK171704 CAPRI Corpectomy Cage SystemK2m · 2017
- 1 generation backK180665 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018
- This deviceK200235 KONG-TL VBR System, KONG-C VBR SystemIcotec AG · 2020
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −22 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −21 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −20 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −17 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −16 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −13 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −12 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −11 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −10 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −9 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −8 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −7 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −6 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −5 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −4 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −3 | K170055 | CAPRI Corpectomy Cage System | K2m | 2017 | — |
| −2 | K171704 | CAPRI Corpectomy Cage System | K2m | 2017 | — |
| −1 | K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | K2m, LLC | 2018 | — |
| 0 (this device) | K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG | 2020 | — |
| +1 | K232790 | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 17 | 0 |
| 2004 | 27 | 0 |
| 2005 | 20 | 0 |
| 2006 | 13 | 0 |
| 2007 | 15 | 0 |
| 2008 | 43 | 1 |
| 2009 | 28 | 0 |
| 2010 | 17 | 0 |
| 2011 | 25 | 0 |
| 2012 | 14 | 0 |
| 2013 | 9 | 0 |
| 2014 | 16 | 0 |
| 2015 | 10 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191778 | Omnia Medical VBRSummary page 5…§888.3060, Spinal intervertebral body fixation orthosis Class: II Product Code: MQP, PLR Primary Predicates: Omnia Medical VBR (K191778), Additional Predicates: NuVasive Monolith Cervical Corpectomy System (K180550), Ulrich Small VBR… | 2019 |
| * | K180550 | NuVasive Monolith Cervical Corpectomy SystemSummary page 5…I Product Code: MQP, PLR Primary Predicates: Omnia Medical VBR (K191778), Additional Predicates: NuVasive Monolith Cervical Corpectomy System (K180550), Ulrich Small VBR (K192117), Solidity™ Vertebral Body Replacement (K181921… | 2018 |
| * | K192117 | Small VBR™Summary page 5…tes: Omnia Medical VBR (K191778), Additional Predicates: NuVasive Monolith Cervical Corpectomy System (K180550), Ulrich Small VBR (K192117), Solidity™ Vertebral Body Replacement (K181921), CAPRI Corpectomy Cage System (K180665), Obelisc… | 2019 |
| * | K181921 | Solidity Vertebral Body ReplacementSummary page 5…ve Monolith Cervical Corpectomy System (K180550), Ulrich Small VBR (K192117), Solidity™ Vertebral Body Replacement (K181921), CAPRI Corpectomy Cage System (K180665), Obelisc Vertebral Body Replacement Device (K060416), Synthes… | 2018 |
| * | K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemSummary page 5…K180550), Ulrich Small VBR (K192117), Solidity™ Vertebral Body Replacement (K181921), CAPRI Corpectomy Cage System (K180665), Obelisc Vertebral Body Replacement Device (K060416), Synthes CRL System (… | 2018 |
| * | K060416 | Obelisc Vertebral Body Replacement DeviceSummary page 5…bral Body Replacement (K181921), CAPRI Corpectomy Cage System (K180665), Obelisc Vertebral Body Replacement Device (K060416), Synthes CRL System (K103320) Reference Devices: icotec VADER®one Pedicle System MIS and Li… | 2006 |
| * | K103320 | Synthes XRLSummary page 5…), CAPRI Corpectomy Cage System (K180665), Obelisc Vertebral Body Replacement Device (K060416), Synthes CRL System (K103320) Reference Devices: icotec VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K… | 2011 |
| † | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | 2019 |
| † | K172480 | icotec Interbody Cage System | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232790 | KONG®-TL VBR System and KONG® C VBR System | 2024 | 0 |
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 15 companies; a new generation was cleared every 10 months on median.
- 42 of the 318 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K232790 (Icotec AG, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K191778.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
Cervical KONG®-C VBR System devices are intended for use in the cervical spine (from C2 to T1) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. KONG®-C VBR System is intended to be used with supplemental fixation cleared by the FDA…
Read the full statement (279 words)
Cervical
KONG®-C VBR System devices are intended for use in the cervical spine (from C2 to T1) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. KONG®-C VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
Thoracolumbar
KONG®-TL VBR System devices are intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). When used in the thoracolumbar spine, the KONG®-TL VBR System is intended to be used with FDA-cleared supplemental fixation appropriate for the implanted level, including icotec Pedicle Screw Systems.
These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200235: KONG-TL VBR System, KONG-C VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200235
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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