510(k) Report

FDA product code · Orthopedic

Prosthesis, Intervertebral Disc

MJOClass IIIPMA required15 decisions since 20048 recalls

15 FDA decisions since 2004. 8 recalls name this code, 0 of them Class I. The most-cited predicate is P200022, named by 1 later device.

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

FIG. A — Illustration, orthopedic panel

Twenty years of MJO at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · MJO

13in 2025

2007: 42008: 52009: 12010: 62011: 112012: 62013: 122014: 252015: 112016: 142017: 152018: 92019: 122020: 212021: 172022: 112023: 122024: 132025: 132026 (partial year): 14
2007high 25 (2014) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MJO

Too few MJO 510(k)s in any year since 2007 to give a median.

Recalls per year · MJO

6in 2007

2007: 62026 (partial year): 2
2007high 6 (2007) · low 0 (2008)2026

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

Adverse event reports per year · MJO

262in 2025

2007: 2782008: 1042009: 2832010: 1742011: 2512012: 3142013: 3712014: 3282015: 7242016: 1612017: 2772018: 3692019: 3802020: 3452021: 3082022: 2632023: 2782024: 3152025: 262
2007high 724 (2015) · low 104 (2008)2025

MAUDE reports naming product code MJO, 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
20074—6278
20085—0104
20091—0283
20106—0174
201111—0251
20126—0314
201312—0371
201425—0328
201511—0724
201614—0161
201715—0277
20189—0369
201912—0380
202021—0345
202117—0308
202211—0263
202312—0278
202413—0315
202513—0262
202614—2—
FIG. 1 — MJO by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MJO? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report