Cleared Traditional

PE-PLUS ACETABULAR CUP (K992153) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992153 · Plus Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
90d
Days
Class 2
Risk

K992153 is an FDA 510(k) clearance for the PE-PLUS ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Plus Orthopedics (San Diego, US). The FDA issued a Cleared decision on September 23, 1999 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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: Standard predicate-based submission. Standard predicate reliance. 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 Plus Orthopedics devices

Submission Details

510(k) Number K992153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1999
Decision Date September 23, 1999
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K992153.
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
K001335 · Exactech, Inc. · May 2000
PAR 5 ACETABULAR COMPONENT
K000254 · Biomet, Inc. · Feb 2000
MALLORY/HEAD SMOOTH FEMORAL COMPONENT
K994007 · Biomet, Inc. · Feb 2000
COLOR BUFFED CEMENTED FEMORAL
K992903 · Biomet, Inc. · Sep 1999
BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
K992058 · Biomet, Inc. · Jul 1999
COLOR BUFFED ANSWER CEMENTED FEMORAL
K991987 · Biomet, Inc. · Jun 1999