510(k) Report

510(k) · Cleared

Recalled · 2007

Novel VBR Spinal System

K050553510(k) SpecialCleared Apr 18, 200546-day reviewClass II21 CFR 888.3060Recalls 1

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

Alphatec/Nexmed · MQP Spinal Vertebral Body Replacement Device

Cleared on Apr 18, 2005 after a 46-day review. The FDA summary names its predicate without a number. 381 later devices descend from it. It has been recalled once.

Decided
Apr 18, 2005
Review
46 days
Class
Class II
Product code
MQP
Recalls
1
Predicates
0

381 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2015: 5 descendants cleared2011: 1 descendant cleared2005: 1 descendant cleared2012: 2 descendants cleared2006: 1 descendant cleared2007: 3 descendants cleared2023: 49 descendants cleared2014: 3 descendants cleared2008: 1 descendant cleared2020: 31 descendants cleared2013: 2 descendants cleared2017: 17 descendants cleared2019: 23 descendants cleared2016: 6 descendants cleared2018: 17 descendants cleared2026: 45 descendants cleared2021: 29 descendants cleared2024: 53 descendants cleared2022: 41 descendants cleared2025: 51 descendants cleared20052010201520202025
  1. This deviceK050553 Novel VBR Spinal SystemAlphatec/Nexmed · 2005
  2. Descendant · cites it directly · 322 of its ownK120570 Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP · 2012
  3. Descendant · 2 generations on · 251 of its ownK130573 Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC · 2013
  4. Descendant · 3 generations on · 227 of its ownK133967 Interbody Cage SystemAurora Spine · 2014
  5. Descendant · 4 generations on · 210 of its ownK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
  6. Descendant · cites it directly · 175 of its ownK062151 Box Peek VBR SystemInnovasis, Inc. · 2006

Showing 5 of 381 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 32008: 12011: 12012: 22013: 22014: 32015: 52016: 62017: 172018: 172019: 232020: 312021: 292022: 412023: 492024: 532025: 512026: 45
2005high 53 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 381 · See all
  • K120570Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP · 2012 · cites it directly322descendants
  • K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC · 2013 · 2 generations on251descendants
  • K133967Interbody Cage SystemAurora Spine · 2014 · 3 generations on227descendants
  • K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · 4 generations on210descendants
  • K062151Box Peek VBR SystemInnovasis, Inc. · 2006 · cites it directly175descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K050553Novel VBR Spinal SystemAlphatec/Nexmed2005—
+1K120570Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP2012—
+2K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013—
+3K133967Interbody Cage SystemAurora Spine2014—
+4K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS…Globus Medical, Inc.2016—
+1K062151Box Peek VBR SystemInnovasis, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200730
200810
201110
201220
201320
201430
201550
201660
2017170
2018170
2019230
2020310
2021290
2022410
2023490
2024530
2025510
2026450
FIG. 1 — Lineage of K050553, 2005–2026Source: 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 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? (1)

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
*—NOVEL VBR Spinal System manufactured from titanium alloy
Named without a submission number
—

What descends from it? (381)

See all 381

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

NumberDeviceApplicantDecidedDescendants
K120570Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP2012322
K062151Box Peek VBR SystemInnovasis, Inc.2006175
K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated201513
K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated201513
K052170Seaspine VBR SystemSeaspine, Inc.200513
K103320Synthes XRLSynthes Spine Co.Lp20113
K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072
K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 16, 2007Not classifiedZ-0508-2009Process controlFirm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K120570 (Choicespine, LP, 2012) has gone furthest, with 322 descendants of its own.

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.

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 NOVEL TM VBR Spinal System is 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). The NovelTM VBR System is intended for use with supplemental spinal fixation systems. Specifically, the Novel VBR System is to be used with the Alphatec Zodiac TM Polyaxial Pedicle Screw System or the Alphatec Mirage' TM Top Tightening Spinal System. Furthermore, the Novel VBR System is intended for use with bone graft.

Indications for use as stated in the FDA summary.

More from Alphatec/Nexmed

9 FDA decisions under this applicant name. See the company

  • K050830Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
  • K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
  • K050390Tamarack Anterior ThoracolunbarAlphatec/Nexmed · 2005
  • K050078Roc Lumbar Plating SystemAlphatec/Nexmed · 2005
  • K042252Nexflex Total Hip SystemAlphatec/Nexmed · 2004

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/K050553 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050553: Novel VBR Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050553

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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