Cleared Traditional

K001277 - TRIFLANGE ACETABULAR CUP SYSTEM

K001277 is an FDA 510(k) clearance for TRIFLANGE ACETABULAR CUP SYSTEM, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K001277 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
63d
Days
Class 2
Risk

K001277 is an FDA 510(k) clearance for the TRIFLANGE ACETABULAR CUP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 23, 2000 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K001277

510(k) Number K001277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2000
Decision Date June 23, 2000
Days to Decision 63 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 122d · This submission: 63d
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 453
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K001277.
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
THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
K001039 · Implex Corp. · Jun 2000
MALLORY HEAD MODULAR CALCAR
K001660 · Biomet Orthopedics, Inc. · Jun 2000
PINNACLE ACETABULAR SYSTEM
K001534 · DePuy Orthopaedics, Inc. · Jun 2000