Cleared Traditional

K971018 - SMC ACETABULAR COMPONENT

K971018 is an FDA 510(k) clearance for SMC ACETABULAR COMPONENT, manufactured by Signal Medical Corp.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K971018 · Signal Medical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
218d
Days
Class 2
Risk

K971018 is an FDA 510(k) clearance for the SMC ACETABULAR COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Signal Medical Corp. (Lakeport, US). The FDA issued a Cleared decision on October 24, 1997 after a review of 218 days - an extended review 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: 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 Signal Medical Corp. devices

FDA 510(k) Submission Details - K971018

510(k) Number K971018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1997
Decision Date October 24, 1997
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

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 489
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K971018.
ACETABULAR SHELLS WITH MESH INGROWTH SURFACE
K973163 · Howmedica Corp. · Nov 1997
DEPUY DURALOC ACETABULAR CUP SYSTEM
K972596 · Depuy, Inc. · Nov 1997
APR POROUS HA HIP SYSTEM
K973124 · Sulzer Orthopedics, Inc. · Nov 1997
INFINTY DISTAL FEMORAL COMPONENT
K973530 · Wrightmedicaltechnologyinc · Oct 1997
INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)
K972393 · Sulzer Orthopedics, Inc. · Sep 1997
DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K970241 · Depuy, Inc. · Aug 1997