Cleared Traditional

K031165 - PLUS ORTHOPEDICS CEMENTED HIP STEM

K031165 is an FDA 510(k) clearance for PLUS ORTHOPEDICS CEMENTED HIP STEM, 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 53-day FDA review.

K031165 · Plus Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
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Jun 2003
Decision
53d
Days
Class 2
Risk

K031165 is an FDA 510(k) clearance for the PLUS ORTHOPEDICS CEMENTED HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Plus Orthopedics (Round Rock, US). The FDA issued a Cleared decision on June 6, 2003 after a review of 53 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Plus Orthopedics devices

FDA 510(k) Submission Details - K031165

510(k) Number K031165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2003
Decision Date June 06, 2003
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
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 K031165.
OMNIFIT HFX HIP STEM SERIES
K031744 · Howmedica Osteonics Corp. · Aug 2003
OXINIUM FEMORAL HEADS
K030766 · Smith & Nephew, Inc. · Jul 2003
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
K031734 · Biomet, Inc. · Jul 2003
ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
K030153 · Zimmer, Inc. · Apr 2003
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
K030265 · Zimmer, Inc. · Mar 2003
SMITH & NEPHEW FEMORAL HEADS
K024340 · Smith & Nephew, Inc. · Feb 2003