Cleared Traditional

K992153 - PE-PLUS ACETABULAR CUP

K992153 is an FDA 510(k) clearance for PE-PLUS ACETABULAR CUP, manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K992153

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
Combination Product No
PCCP Authorized No
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.

JDI Device Classification - Class 2, Special Controls

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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K992153.
PAR 5 ACETABULAR COMPONENT
K000254 · Biomet, Inc. · Feb 2000
MALLORY/HEAD SMOOTH FEMORAL COMPONENT
K994007 · Biomet, Inc. · Feb 2000
THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ
K992409 · Implex Corp. · Oct 1999
COLOR BUFFED CEMENTED FEMORAL
K992903 · Biomet, Inc. · Sep 1999
26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER
K991622 · Stelkast Company · Jul 1999
COBREX HIP STEM, MODEL 01-128-XXXXX
K991869 · Implex Corp. · Jul 1999