Cleared Traditional

CL HIP STEM H/A COATED (K922613) - 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
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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 104
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K922613.
OSTEONICS(R) THREADED HA ACETABULAR SHELLS
K945691 · Osteonics Corp. · Mar 1995
OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM
K942900 · Osteonics Corp. · Mar 1995
RESTORATION HA ACETABULAR CUP SERIES
K943957 · Osteonics Corp. · Mar 1995
STABILITY FEMORAL PROSTHESIS W/HAP
K915655 · Depuy, Inc. · Feb 1994
HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE
K925607 · Zimmer, Inc. · Nov 1993
CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING
K926299 · Depuy, Inc. · Oct 1993