FDA PRODUCT CODE · CLASS III
MJO — Prosthesis, Intervertebral Disc
What these counts are not
Clearance and recall counts are SPEQ’s aggregation of FDA’s own published records for the code. A recall count is a measure of history, not of a device’s safety, neither number is an FDA rating, and SPEQ is not affiliated with the FDA.
What this classification requires
Every statement below is FDA’s own classification record for this product code, quoted from the device classification field reference. The SPEQ reading beneath each one is SPEQ’s interpretation of what it means for the work, and is not FDA text.
PMA
SPEQ READINGPremarket approval under 21 CFR Part 814. FDA reviews safety and effectiveness directly rather than by comparison, so clinical evidence is normally expected and the quality system is inspected before approval rather than after marketing.
Class III (high risk): general controls and Premarket Approval (PMA)
SPEQ READINGGeneral controls are insufficient to assure safety and effectiveness, so approval rests on direct evidence rather than equivalence.
Device is eligible for The Voluntary Malfunction Summary Reporting Program
SPEQ READINGMalfunctions for this code may be reported in periodic summary form rather than as individual MDRs under 21 CFR Part 803. Eligibility is a property of the product code; using it is a decision the manufacturer makes and must be able to justify.
Not exempt due to Good Manufacturing Practice (GMP)/Quality System
SPEQ READINGThe full Quality Management System Regulation (21 CFR 820, incorporating ISO 13485:2016) applies, and is what an FDA inspection of this device will be conducted against.
Device is implantable
SPEQ READINGImplant status raises the evidentiary bar on biocompatibility and on traceability from finished device back to material lot.
Device is not used for life sustaining purposes
SPEQ READINGNo life-sustaining designation attaches to this code.
Device is not a candidate for a third party review program
SPEQ READINGFDA reviews any premarket notification for this code directly.
Recent clearances
Recent recalls
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be imporperly seated.
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
Source: FDA device classification, 510(k)/PMA, and recall datasets. Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. Browse every product code SPEQ tracks →