Cleared Special

MPF ACETABULAR CUP GENERATION 2 (K022120) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K022120 · Plus Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
23d
Days
Class 2
Risk

K022120 is an FDA 510(k) clearance for the MPF ACETABULAR CUP GENERATION 2. 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 July 24, 2002 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Plus Orthopedics devices

Submission Details

510(k) Number K022120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2002
Decision Date July 24, 2002
Days to Decision 23 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 291
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K022120.
GMRS PRESS FIT STEMS WITH PUREFIX HA
K022403 · Howmedica Osteonics Corp. · Oct 2002
RESTORATION MODULAR SYSTEM
K022549 · Howmedica Osteonics Corp. · Sep 2002
ACCOLADE C FEMORAL STEMS
K022555 · Howmedica Osteonics Corp. · Aug 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673 · Smith & Nephew, Inc. · Jun 2002
2 PIECE MODULAR HIP STEM
K013106 · Howmedica Osteonics Corp. · Apr 2002
DEPUY FEMORAL HEADS
K011533 · DePuy Orthopaedics, Inc. · Jan 2002