510(k) Report

510(k) · Cleared

Cleared

Choice Spine Vertebral Body Replacement (VBR) Device System

K120570510(k) TraditionalCleared Apr 5, 201238-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Choicespine, LP · MQP Spinal Vertebral Body Replacement Device

Cleared on Apr 5, 2012 as substantially equivalent to K050553 (Alphatec/Nexmed, 2005) and 2 other predicates after a 38-day review. Its family tree reaches back 6 generations to 2001. 322 later devices descend from it.

Decided
Apr 5, 2012
Review
38 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K003275 (2001). 8 ancestors in all. 322 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2005: 1 other ancestor2015: 2 descendants cleared2013: 1 descendant cleared2017: 10 descendants cleared2020: 28 descendants cleared2019: 15 descendants cleared2016: 3 descendants cleared2014: 2 descendants cleared2018: 13 descendants cleared2026: 41 descendants cleared2021: 27 descendants cleared2023: 45 descendants cleared2022: 36 descendants cleared2024: 51 descendants cleared2025: 48 descendants clearedK003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalledK020152 · Synthes Vertebral Spacer TI · Synthes (Usa) · 2002×2: 2 generations cleared close together, K024364 (2003), K031302 (2003) K040284 · Sustain Radiolucent Spacer · Globus Medical, Inc. · 2004K072465 · Niko Corpectomy Spacer · Globus Medical, Inc. · 2007200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 17 descendants3 generations forward: 32 descendants4 generations forward: 44 descendants5 generations forward: 63 descendants6 generations forward: 80 descendants7 generations forward: 55 descendants8 generations forward: 20 descendants9 generations forward: 5 descendants10 generations forward: 3 descendants K072465 · Niko Corpectomy Spacer · Globus Medical, Inc. · 2007K040284 · Sustain Radiolucent Spacer · Globus Medical, Inc. · 2004K031302 · Sustain Spacer · Globus Medical, Inc. · 2003K024364 · Synthes Vertebral Spacer TI (Curved and Narrow) · Synthes (Usa) · 2003K020152 · Synthes Vertebral Spacer TI · Synthes (Usa) · 2002K003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalled−50+5+10
  1. Root · 6 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
  2. 5 generations backK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
  3. 4 generations backK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
  4. 3 generations backK031302 Sustain SpacerGlobus Medical, Inc. · 2003
  5. 2 generations backK040284 Sustain Radiolucent SpacerGlobus Medical, Inc. · 2004
  6. 1 generation backK072465 Niko Corpectomy SpacerGlobus Medical, Inc. · 2007
  7. This deviceK120570 Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP · 2012
  8. Descendant · cites it directly · 251 of its ownK130573 Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC · 2013
  9. Descendant · 2 generations on · 227 of its ownK133967 Interbody Cage SystemAurora Spine · 2014
  10. Descendant · 3 generations on · 210 of its ownK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
  11. Descendant · 4 generations on · 117 of its ownK161223 TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016
  12. Descendant · cites it directly · 116 of its ownK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017

Showing 5 of 322 descendants. See all descendants

Descendants cleared per year

2013: 12014: 22015: 22016: 32017: 102018: 132019: 152020: 282021: 272022: 362023: 452024: 512025: 482026: 41
2013high 51 (2024) · low 1 (2013)2026

Most influential descendants

Showing 5 of 322 · See all
  • K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC · 2013 · cites it directly251descendants
  • K133967Interbody Cage SystemAurora Spine · 2014 · 2 generations on227descendants
  • K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · 3 generations on210descendants
  • K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016 · 4 generations on117descendants
  • K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017 · cites it directly116descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K003275Synthes Synmesh Spacer SystemSynthes (Usa)200114
−5K020152Synthes Vertebral Spacer TISynthes (Usa)2002—
−4K024364Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa)2003—
−3K031302Sustain SpacerGlobus Medical, Inc.2003—
−2K040284Sustain Radiolucent SpacerGlobus Medical, Inc.2004—
−1K072465Niko Corpectomy SpacerGlobus Medical, Inc.2007—
0 (this device)K120570Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP2012—
+1K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013—
+2K133967Interbody Cage SystemAurora Spine2014—
+3K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS…Globus Medical, Inc.2016—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016—
+1K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201420
201520
201630
2017100
2018130
2019150
2020280
2021270
2022360
2023450
2024510
2025480
2026410
FIG. 1 — Lineage of K120570, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 MQP? 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. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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? (3)

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
*K050553Novel VBR Spinal System
Summary page 1
…ication & Device Product Codes 888.3060 MOP - Spinal intervertebral body fixation orthosis Predicate Devices Alphatec Spine Novel VBR Spinal System (K050553) Globus Medical NIKO Corpectomy Spacer (K072465) Verticor Samson Corpectomy Cage (K091426) Device Description…
Alphatec/Nexmed20051
*K072465Niko Corpectomy Spacer
Summary page 1
…- Spinal intervertebral body fixation orthosis Predicate Devices Alphatec Spine Novel VBR Spinal System (K050553) Globus Medical NIKO Corpectomy Spacer (K072465) Verticor Samson Corpectomy Cage (K091426) Device Description The Choice Spine Vertebral Body Replacement (VBR) S…
Globus Medical, Inc.2007—
*K091426Cervicore Corpectomy Cage
Summary page 1
…Predicate Devices Alphatec Spine Novel VBR Spinal System (K050553) Globus Medical NIKO Corpectomy Spacer (K072465) Verticor Samson Corpectomy Cage (K091426) Device Description The Choice Spine Vertebral Body Replacement (VBR) System devices have a basic oval shape with…
Verticor, Ltd.2009—

Also cleared against K050553: 7 other devices →

What descends from it? (322)

See all 322

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

NumberDeviceApplicantDecidedDescendants
K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251
K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116
K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513

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 3 companies; a new generation was cleared every 12 months on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K130573 (Tyber Medical, LLC, 2013) has gone furthest, with 251 descendants of its own.
  • 7 other devices also cite its predicate K050553.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

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

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

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

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, 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
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The Choice Spine Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The VBR device is intended for use with supplemental fixation & is to be used with autograft and/or allograft bone graft material.

Indications for use as stated in the FDA summary.

Also cleared against K050553

7 other devices cite the same predicate.

  • K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc. · 2023
  • K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated · 2015
  • K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated · 2015
  • K103320Synthes XRLSynthes Spine Co.Lp · 20111 recall
  • K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc. · 2007
  • K062151Box Peek VBR SystemInnovasis, Inc. · 2006

More from Choicespine, LP

22 FDA decisions under this applicant name. See the company

  • K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019
  • K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP · 2019
  • K182721Choice Spine Navigation SystemChoicespine, LP · 2019
  • K183214Raven Lumbar Plate SystemChoicespine, LP · 2019
  • K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP · 2018

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K120570 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120570: Choice Spine Vertebral Body Replacement (VBR) Device System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120570

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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