Cleared Traditional

K042565 - ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER

K042565 is an FDA 510(k) clearance for ENCOMPASS HIP STEM, manufactured by Ortho Development Corp.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K042565 · Ortho Development Corp. · Orthopedic device
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Apr 2005
Decision
202d
Days
Class 2
Risk

K042565 is an FDA 510(k) clearance for the ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on April 11, 2005 after a review of 202 days - an extended review 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: 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 Ortho Development Corp. devices

FDA 510(k) Submission Details - K042565

510(k) Number K042565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2004
Decision Date April 11, 2005
Days to Decision 202 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 122d · This submission: 202d
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 543
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K042565.
TRABECULAR METAL PRIMARY HIP PROSTHESIS
K051491 · Zimmer, Inc. · Jun 2005
TRABECULAR METAL ACETABULAR REVISION SHELLS
K050937 · Zimmer Trabecular · May 2005
RX90 LOW PROFILE ACETABULAR SYSTEM
K042989 · Biomet, Inc. · Apr 2005
ARCOMXL POLYETHYLENE LINERS
K042051 · Biomet, Inc. · Mar 2005
TRIDENT ACETABULAR SYSTEM
K033716 · Howmedica Osteonics Corp. · Feb 2005
APEX MODULAR HA HIP STEM
K043123 · Apex Surgical, LLC · Feb 2005