Cleared Traditional

K922613 - CL HIP STEM H/A COATED (FDA 510(k) Clearance)

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

K922613 · Lima Intl. Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
672d
Days
Class 2
Risk

K922613 is an FDA 510(k) clearance for the CL HIP STEM H/A COATED. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Lima Intl. Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 5, 1994 after a review of 672 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Lima Intl. Corp. devices

Submission Details

510(k) Number K922613 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 02, 1992
Decision Date April 05, 1994
Days to Decision 672 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
550d slower than avg
Panel avg: 122d · This submission: 672d
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 K922613.
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