Cleared Traditional

K921384 - PCA ACETABULAR INSERT II

K921384 is the FDA 510(k) clearance for PCA ACETABULAR INSERT II by Howmedica Corp.. It is a Class 3 Orthopedic device (product code JDL) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K921384 · Howmedica Corp. · Orthopedic device
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Jun 1992
Decision
94d
Days
Class 3
Risk

K921384 is an FDA 510(k) clearance for the PCA ACETABULAR INSERT II. Classified as Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (product code JDL), Class III - Premarket Approval.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on June 25, 1992 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3320 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Corp. devices

Submission Details

510(k) Number K921384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1992
Decision Date June 25, 1992
Days to Decision 94 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 122d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JDL Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3320
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - JDL Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)

All 28
Devices cleared under the same product code (JDL) and FDA review panel - the closest regulatory comparables to K921384.
PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES
K934440 · Howmedica Corp. · Feb 1994
POLY INSERT 20 DEGREE
K920929 · Dow Corning Wright · May 1993
HEALEY REVISION COMPONENT SYSTEM
K921139 · Biomet, Inc. · Jul 1992
ACETABULAR DOME AND SCREW HOLE PLUGS
K920868 · Osteonics Corp. · May 1992
POROUS-COATED TITANIUM ACETABULAR CUP
K894965 · Dow Corning Wright · Nov 1989
POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT
K895607 · Exactech, Inc. · Nov 1989