Cleared Traditional

RHS ACETABULAR COMPONENT (K022382) - FDA 510(k) Clearance

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

K022382 · Signal Medical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
74d
Days
Class 2
Risk

K022382 is an FDA 510(k) clearance for the RHS ACETABULAR COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Signal Medical Corp. (Port Huron, US). The FDA issued a Cleared decision on October 4, 2002 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 Signal Medical Corp. devices

Submission Details

510(k) Number K022382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2002
Decision Date October 04, 2002
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K022382.
ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT
K030236 · Exactech, Inc. · Feb 2003
VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS
K030079 · Zimmer, Inc. · Feb 2003
HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
K023409 · Biomet, Inc. · Nov 2002
SMITH & NEPHEW HIP SYSTEM
K022902 · Smith & Nephew, Inc. · Oct 2002
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K021891 · Zimmer, Inc. · Sep 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556 · Smith & Nephew, Inc. · Aug 2002