Cleared Traditional

APEX MODULAR HIP STEM (K000788) - FDA 510(k) Clearance

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

K000788 · Apex Surgical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K000788.
MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL
K003429 · Biomet, Inc. · Nov 2000
LINEAGE ACETABULAR SYSTEM
K002149 · Wrightmedicaltechnologyinc · Aug 2000
TITAN POROCOAT HIP PROSTHESIS
K001991 · DePuy Orthopaedics, Inc. · Aug 2000
TRI-LOCK HIP STEM
K001982 · DePuy Orthopaedics, Inc. · Jul 2000
POROCOAT PRODIGY HIP PROSTHESIS
K001778 · DePuy Orthopaedics, Inc. · Jul 2000
TRIFLANGE ACETABULAR CUP SYSTEM
K001277 · DePuy Orthopaedics, Inc. · Jun 2000