Cleared Traditional

K980981 - OMEGA HA COATED TOTAL HIP SYSTEM

K980981 is an FDA 510(k) clearance for OMEGA HA COATED TOTAL HIP SYSTEM, manufactured by Osteoimplant Technology, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K980981 · Osteoimplant Technology, Inc. · Orthopedic device
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May 1998
Decision
64d
Days
Class 2
Risk

K980981 is an FDA 510(k) clearance for the OMEGA HA COATED TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Osteoimplant Technology, Inc. (Hunt Valley, US). The FDA issued a Cleared decision on May 20, 1998 after a review of 64 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 Osteoimplant Technology, Inc. devices

FDA 510(k) Submission Details - K980981

510(k) Number K980981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1998
Decision Date May 20, 1998
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
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 476
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K980981.
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REACH HIP COMPONENT
K982367 · Biomet, Inc. · Aug 1998
APR -T REVISION HIP STEM
K981211 · Sulzer Orthopedics, Inc. · May 1998
DEPUY TRI-LOCK HIP STEM
K974740 · Depuy, Inc. · Mar 1998
LSF HA COATED TRIAD TOTAL HIP SYSTEM
K974506 · Osteoimplant Technology, Inc. · Feb 1998
MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING
K971206 · Howmedica Corp. · Feb 1998