510(k) Report

FDA product code · Orthopedic

Prosthesis, Subtalar, Plug, Polymer

MJWClass II21 CFR 888.3040510(k) required2 decisions since 19920 recalls

2 FDA decisions since 1992. No recall names this code. The most-cited predicate is K033046, named by 2 later devices.

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 MJW 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 · MJW

FDA has decided no MJW device since 2007.

Median 510(k) review, days · MJW

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

Recalls per year · MJW

No recall names MJW since 2007.

Adverse event reports per year · MJW

1in 2017

2007: 12011: 22017: 1
2007high 2 (2011) · low 0 (2008)2025

MAUDE reports naming product code MJW, 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
20070—01
20080—00
20090—00
20100—00
20110—02
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MJW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MJW? 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

Which predicates do MJW devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K033046Subtalar Peg ImplantNexa Orthopedics, Inc. · 20032cite it

Which MJW devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K033046Subtalar Peg ImplantNexa Orthopedics, Inc. · 20031generation

What has FDA decided in MJW lately?

  • K033046Subtalar Peg ImplantNexa Orthopedics, Inc. · 2003
  • K922292Lundeen Subtalar Peg ImplantSgarlato Laboratories, Inc. · 1992

All 2 MJW decisions →

Related product codes

Other codes under 21 CFR 888.3040.

HWC Screw, Fixation, BoneNDL Pin, Fixation, Smooth, MetallicQSR Sacroiliac Screw Placement GuideJEC Component, Traction, InvasiveMBI Fastener, Fixation, Nondegradable, Soft TissueMRY Appliances And Accessories, Fixation, Bone…PPQ Transtibial Anterior Cruciate Ligament KitNJA Accessory, System, External Fixator…SCY Sacroiliac Joint Guidewire Placement DeviceHTY Pin, Fixation, SmoothNDJ Screw, Fixation, Bone, Non-Spinal, MetallicOVZ Pin, Fixation, Resorbable, Hard Tissue