510(k) Report

510(k) · Cleared

Cleared

Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage

K173800510(k) TraditionalCleared Feb 2, 201850-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

Camber Spine Technologies · MQP Spinal Vertebral Body Replacement Device

Cleared on Feb 2, 2018 as substantially equivalent to K143490 (Camber Spine, 2015) and 2 other predicates after a 50-day review. Its family tree reaches back 7 generations to 2001.

Decided
Feb 2, 2018
Review
50 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to K003275 (2001). 10 ancestors in all, the oldest K003155 (2001). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 3 other ancestorsReference device: K172446 · SPIRA-C Open Matrix Cervical Interbody · Camber Spine Technologies · 2017Reference device: K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalledK020152 · Synthes Vertebral Spacer TI · Synthes (Usa) · 2002K024364 · Synthes Vertebral Spacer TI (Curved and Narrow) · Synthes (Usa) · 2003K031302 · Sustain Spacer · Globus Medical, Inc. · 2003K040284 · Sustain Radiolucent Spacer · Globus Medical, Inc. · 2004K072465 · Niko Corpectomy Spacer · Globus Medical, Inc. · 2007K143490 · VERTA Corpectomy Cage · Camber Spine · 201520002005201020152020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K143490 · VERTA Corpectomy Cage · Camber Spine · 2015K072465 · 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
  1. Root · 7 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
  2. 6 generations backK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
  3. 5 generations backK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
  4. 4 generations backK031302 Sustain SpacerGlobus Medical, Inc. · 2003
  5. 3 generations backK040284 Sustain Radiolucent SpacerGlobus Medical, Inc. · 2004
  6. 2 generations backK072465 Niko Corpectomy SpacerGlobus Medical, Inc. · 2007
  7. 1 generation backK143490 VERTA Corpectomy CageCamber Spine · 2015
  8. This deviceK173800 Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy CageCamber Spine Technologies · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K003275Synthes Synmesh Spacer SystemSynthes (Usa)200114
−6K020152Synthes Vertebral Spacer TISynthes (Usa)2002—
−5K024364Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa)2003—
−4K031302Sustain SpacerGlobus Medical, Inc.2003—
−3K040284Sustain Radiolucent SpacerGlobus Medical, Inc.2004—
−2K072465Niko Corpectomy SpacerGlobus Medical, Inc.2007—
−1K143490VERTA Corpectomy CageCamber Spine2015—
0 (this device)K173800Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy CageCamber Spine Technologies2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200130
FIG. 1 — Lineage of K173800, 2001–2018Source: 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? (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
*K143490VERTA Corpectomy Cage
Summary page 4
…8.3060, Spinal intervertebral body fixation orthosis Class: II Product Codes: MQP Primary Predicate: Camber Spine VERTA (K143490) Additional Predicates: Osteotech VBR (K012254), Interpore Geo Structure (K010530) Reference Devices: Camber Sp…
Camber Spine2015—
*K012254VBR
Summary page 4
…Class: II Product Codes: MQP Primary Predicate: Camber Spine VERTA (K143490) Additional Predicates: Osteotech VBR (K012254), Interpore Geo Structure (K010530) Reference Devices: Camber Spine SPIRA-C Open Matrix Cervical Interbody…
Osteotech, Inc.2001—
*K010530Geo Structure
Summary page 4
…oduct Codes: MQP Primary Predicate: Camber Spine VERTA (K143490) Additional Predicates: Osteotech VBR (K012254), Interpore Geo Structure (K010530) Reference Devices: Camber Spine SPIRA-C Open Matrix Cervical Interbody (K172446), Rezaia…
Interpore Cross Intl.2001—
†K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies2017—
†K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—

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 17 years and passes through 4 companies; a new generation was cleared every 12 months on median.
  • 1 of the 10 ancestors has a recall of any class.

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. 2018, 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 Camber Spine Technologies SPIRA-V™ Open Matrix Corpectomy Cage is indicated for use in the Thoracolumbar Spine (T1-L5) to replace collapsed, damaged, or an unstable vertebral body due to tumor or trauma (i.e., fracture). The Camber Spine Technologies SPIRA-V™ Open Matrix Corpectomy is intended to be used with additional FDA-cleared supplementary fixation systems.

The Camber Spine Technologies SPIRA-V™ Open Matrix Corpectomy Cage system must be used with autogenous graft material.

Indications for use as stated in the FDA summary.

More from Camber Spine Technologies

17 FDA decisions under this applicant name. See the company

  • K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies · 2024
  • K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies · 2024
  • K230942SPIRA® Posterior Lumbar SpacersCamber Spine Technologies · 2023
  • K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies · 2023
  • K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies · 2023

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/K173800 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173800: Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173800

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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