Cleared Traditional

K000788 - APEX MODULAR HIP STEM

K000788 is an FDA 510(k) clearance for APEX MODULAR HIP STEM, manufactured by Apex Surgical, LLC. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K000788 · Apex Surgical, LLC · Orthopedic device
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Aug 2000
Decision
147d
Days
Class 2
Risk

K000788 is an FDA 510(k) clearance for the APEX MODULAR HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Apex Surgical, LLC (Taunton, US). The FDA issued a Cleared decision on August 4, 2000 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 Apex Surgical, LLC devices

FDA 510(k) Submission Details - K000788

510(k) Number K000788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2000
Decision Date August 04, 2000
Days to Decision 147 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 122d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 509
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K000788.
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K002149 · Wrightmedicaltechnologyinc · Aug 2000
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K001991 · DePuy Orthopaedics, Inc. · Aug 2000
TRI-LOCK HIP STEM
K001982 · DePuy Orthopaedics, Inc. · Jul 2000
SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM
K001320 · Sulzer Orthopedics, Inc. · Jul 2000
POROCOAT PRODIGY HIP PROSTHESIS
K001778 · DePuy Orthopaedics, Inc. · Jul 2000