Cleared Traditional

Exactech? Novation? and AcuMatch? E-HXL Acetabular Liners

K173583 · Exactech, Inc. · Orthopedic

Mar 2018

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K173583 is an FDA 510(k) clearance for the Exactech? Novation? and AcuMatch? E-HXL Acetabular Liners, a Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented (Class II — Special Controls, product code OQI), submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on March 12, 2018, 112 days after receiving the submission on November 20, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K173583 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2017
Decision Date	March 12, 2018
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OQI — Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353
Definition	1. Non-inflammatory Degenerative Joint Disease Including Osteoarthritis And Avascular Necrosis. 2. Rheumatoid Arthritis. 3. Correction Of Functional Deformity. 4. Treatment Of Non-union, Femoral Neck Fracture, And Trochanteric Fractures Of The Proximal Femur With Head Involvement, Unmanageable By Other Techniques. 5. Revision Procedures Where Other Treatment Or Devices Have Failed. Cemented And Uncemented Use.