510(k) Report

FDA product code · Orthopedic

Appliance, Nail/Blade/Plate Combination, Single Component

KWKClass II21 CFR 888.3030510(k) required1 decision since 19940 recalls

1 FDA decision since 1994. No recall names this code.

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 KWK 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 · KWK

FDA has decided no KWK device since 2007.

Median 510(k) review, days · KWK

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

Recalls per year · KWK

No recall names KWK since 2007.

Adverse event reports per year · KWK

No MAUDE report names KWK since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — KWK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KWK? 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

What has FDA decided in KWK lately?

  • K931682Cannulated Malleolar ScrewOnyx Medical Corp. · 1994

The one KWK decision →

Related product codes

Other codes under 21 CFR 888.3030.

JDS Nail, Fixation, BoneNDF Plate, Fixation, Bone, Non-Spinal, MetallicOZI Internal Hinged Elbow FixatorOSN Software For Diagnosis/TreatmentNOV Anchor, Suture, Bone Fixation, MetallicOBT Plate, Bone, Growth Control, Pediatric…LRN Wire, SurgicalPLF Bone WedgeHTN Washer, Bolt NutOOL Electronic Depth GaugeMNU Staple, AbsorbableHRS Plate, Fixation, Bone