510(k) Report

FDA product code · Orthopedic

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented

LPFClass IIIPMA required0 decisions since 19840 recalls

0 FDA decisions since 1984. 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 LPF 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 · LPF

FDA has decided no LPF device since 2007.

Median 510(k) review, days · LPF

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

Recalls per year · LPF

No recall names LPF since 2007.

Adverse event reports per year · LPF

1in 2025

2009: 72010: 62011: 72012: 172013: 92014: 82015: 12018: 12025: 1
2007high 17 (2012) · low 0 (2007)2025

MAUDE reports naming product code LPF, 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—00
20080—00
20090—07
20100—06
20110—07
20120—017
20130—09
20140—08
20150—01
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—
FIG. 1 — LPF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LPF? 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