Cleared Traditional

K954698 - TRILOGY ACETABULAR COMPONENT 7MM OFFSET

K954698 is an FDA 510(k) clearance for TRILOGY ACETABULAR COMPONENT 7MM OFFSET, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K954698 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
97d
Days
Class 2
Risk

K954698 is an FDA 510(k) clearance for the TRILOGY ACETABULAR COMPONENT 7MM OFFSET. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 17, 1996 after a review of 97 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K954698

510(k) Number K954698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1995
Decision Date January 17, 1996
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
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 544
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K954698.
MICRO-SEAL ACETABULAR SYSTEM
K955271 · Whiteside Instruments · Jan 1996
BETA HIP PROSTHESIS
K953337 · Zimmer, Inc. · Jan 1996
S-ROM FEMORAL HIP STEM - SIZE 14 X 8
K954935 · Joint Medical Products Corp. · Jan 1996
DEPUY ADVANTAGE HIP FEMORAL PROSTHESIS WITH POROCOAT
K954811 · Depuy, Inc. · Jan 1996
A-B ACETABULAR COMPONENT
K954417 · Biomet, Inc. · Dec 1995
PROFORM POROUS BEADED FEMORAL STEM
K954466 · Stelkast Company · Dec 1995