Cleared Traditional

K935990 - F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM (FDA 510(k) Clearance)

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

K935990 · Implex Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
211d
Days
Class 2
Risk

K935990 is an FDA 510(k) clearance for the F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on July 13, 1994 after a review of 211 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Implex Corp. devices

Submission Details

510(k) Number K935990 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 14, 1993
Decision Date July 13, 1994
Days to Decision 211 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 122d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 158
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K935990.
Allure Hip Stem and Intramedullary Plugs
K250375 · Waldemar Link GmbH & Co. KG · Nov 2025
Mfinity Femoral System
K251166 · Medacta International S.A. · Jun 2025
Trivicta® Hip Stem
K251052 · Ortho Development Corp. · May 2025
Resolve Modular Revision Hip Stem
K242315 · United Orthopedic Corporation · May 2025
Alteon® HA Femoral Stems
K243839 · Exactech, Inc. · Mar 2025
World Liner
K243162 · Signature Orthopaedics Pty, Ltd. · Nov 2024