Cleared Traditional

K052026 - LINEAGE A-CLASS POLY LINER

K052026 is an FDA 510(k) clearance for LINEAGE A-CLASS POLY LINER, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K052026 · Wrightmedicaltechnologyinc · Orthopedic device
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Dec 2005
Decision
131d
Days
Class 2
Risk

K052026 is an FDA 510(k) clearance for the LINEAGE A-CLASS POLY LINER. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on December 5, 2005 after a review of 131 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K052026

510(k) Number K052026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2005
Decision Date December 05, 2005
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
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 K052026.
VERSYS EPOCH FULLCOAT HIP PROSTHESIS
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DEPUY MODULAR M HEADS
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ESKA-LIBUR HIP STEM
K053557 · Eska Implants GmbH & Co. · Jan 2006
ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS
K052255 · Biomet, Inc. · Nov 2005
E-POLY (VITAMIN E) ACETABULAR LINERS
K050327 · Biomet, Inc. · Sep 2005
ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE
K051556 · Exactech, Inc. · Sep 2005