PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM— 510(k) K073177

Clearance details

Applicant

Pioneer Surgical Technology

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2007-11-13

Decision date

2008-05-13

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Marquette, MI, US

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• K110561 — FORTROSS BONE VOID FILLER2011-04-29
• K101790 — QUANTUM SPINAL SYSTEM, QUANTUM MIS2011-03-07
• K101525 — PIONEER SPINOUS PROCESS FUSION PLATE2010-10-22
• K093692 — QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES2010-08-11
• K093771 — QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM2010-08-10

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0627-2014 — C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended for use with supplemental fixation and autograft. These implants are manufactured from PEEK (Polyaryletheretherketone) polymer with tantalum marker pins for radiographic visualization.Class II·Terminated·RTI Surgical, Inc.·20131007

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073177.