Cleared Traditional

K901687 - F-24 FEMORAL HIP PROSTHESIS

K901687 is an FDA 510(k) clearance for F-24 FEMORAL HIP PROSTHESIS, manufactured by Med-Tek Corp.. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K901687 · Med-Tek Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
148d
Days
Class 2
Risk

K901687 is an FDA 510(k) clearance for the F-24 FEMORAL HIP PROSTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Med-Tek Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 7, 1990 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Med-Tek Corp. devices

FDA 510(k) Submission Details - K901687

510(k) Number K901687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1990
Decision Date September 07, 1990
Days to Decision 148 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 122d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LWJ Device Classification - Class 2, Special Controls

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 74
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K901687.
GERI TOTAL HIP SYSTEM
K905186 · Smith & Nephew Richards, Inc. · Feb 1991
ACSYS SELFTAP ACETABULAR CUP PROSTHESIS
K900262 · 3M Company · Sep 1990
ACSYS SHEARER ACETABULAR CUP PROSTHESIS
K900435 · 3M Company · Sep 1990
KDR ACETABULAR COMPONENT
K895702 · Osteonics Corp. · Nov 1989
FREEMAN TOTAL HIP SYSTEM RIDGED STEM
K890331 · Orthopedic Systems, Inc. · Oct 1989
PREMIER-TOTAL HIP
K894051 · Intermedics Orthopedics · Aug 1989