Cleared Traditional

K003274 - LPC-PLUS ACETABULAR CUP

K003274 is an FDA 510(k) clearance for LPC-PLUS ACETABULAR CUP, manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K003274 · Plus Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
170d
Days
Class 2
Risk

K003274 is an FDA 510(k) clearance for the LPC-PLUS ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Plus Orthopedics (San Diego, US). The FDA issued a Cleared decision on April 6, 2001 after a review of 170 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 - K003274

510(k) Number K003274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2000
Decision Date April 06, 2001
Days to Decision 170 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
48d slower than avg
Panel avg: 122d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K003274.
PRO-FEMUR
K012091 · Wrightmedicaltechnologyinc · Oct 2001
MPF ACETABULAR CUP
K011836 · Plus Orthopedics · Sep 2001
CLS VARUS STEM/CLS 135 STEM
K010839 · Sulzer Orthopedics, Inc. · Apr 2001
PORTRAIT FEMORAL COMPONENT
K010560 · Biomet, Inc. · Mar 2001
V-40/C-TAPER ADAPTER SLEEVE
K003379 · Howmedica Osteonics Corp. · Nov 2000
OSTEONICS ALUMINA C-TAPER HEAD
K003391 · Howmedica Osteonics Corp. · Nov 2000