Cleared Traditional

K971681 - SMC FEMORAL HIP COMPONENT

K971681 is an FDA 510(k) clearance for SMC FEMORAL HIP COMPONENT, manufactured by Signal Medical Corp.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K971681 · Signal Medical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
212d
Days
Class 2
Risk

K971681 is an FDA 510(k) clearance for the SMC FEMORAL HIP COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Signal Medical Corp. (Lakeport, US). The FDA issued a Cleared decision on December 4, 1997 after a review of 212 days - an extended review 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: 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 - K971681

510(k) Number K971681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1997
Decision Date December 04, 1997
Days to Decision 212 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
90d slower than avg
Panel avg: 122d · This submission: 212d
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 495
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K971681.
FOUNDATION FRACTURE STEM
K973809 · Encore Orthopedics, Inc. · Jan 1998
DISTAL CENTRALIZER, EXETER II HIP SYSTEM
K974054 · Howmedica, Inc. · Dec 1997
TORNIER CEMENT RESTRICTOR
K973453 · Tornier · Dec 1997
EXTEND HIP STEM
K973296 · Wrightmedicaltechnologyinc · Nov 1997
THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM
K972995 · Corin USA · Nov 1997
STELKAST BIPOLAR SYSTEM
K972961 · Stelkast Company · Nov 1997