Who is the manufacturer of APEX MODULAR ZIRCONIA FEMORAL HEAD?

Apex Surgical, LLC submitted the Traditional clearance for APEX MODULAR ZIRCONIA FEMORAL HEAD (K003923).

What is the FDA product code for APEX MODULAR ZIRCONIA FEMORAL HEAD?

LZO. It is classified under 21 CFR 888.3353 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for APEX MODULAR ZIRCONIA FEMORAL HEAD?

510(k) clearance (submission type: Traditional).

APEX MODULAR ZIRCONIA FEMORAL HEAD

K003923 · Apex Surgical, LLC · LZO · Mar 20, 2001 · Orthopedic

Device Facts

Record ID	K003923
Device Name	APEX MODULAR ZIRCONIA FEMORAL HEAD
Applicant	Apex Surgical, LLC
Product Code	LZO · Orthopedic
Decision Date	Mar 20, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3353
Device Class	Class 2

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.