510(k) Report

FDA product code · Orthopedic

Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented

OQHClass II21 CFR 888.3350510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.

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 OQH 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 · OQH

FDA has decided no OQH device since 2007.

Median 510(k) review, days · OQH

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

Recalls per year · OQH

No recall names OQH since 2007.

Adverse event reports per year · OQH

1in 2021

2013: 42016: 12019: 12020: 12021: 1
2007high 4 (2013) · low 0 (2007)2025

MAUDE reports naming product code OQH, 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—00
20100—00
20110—00
20120—00
20130—04
20140—00
20150—00
20160—01
20170—00
20180—00
20190—01
20200—01
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OQH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OQH? 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

Related product codes

Other codes under 21 CFR 888.3350.

JDI Prosthesis, Hip, Semi-Constrained…PLW Acetabular Cup Orientation System