Who is the manufacturer of PCA +15MM MODULAR FEMORAL HEAD?

Howmedica Corp. submitted the Traditional clearance for PCA +15MM MODULAR FEMORAL HEAD (K955305).

What is the FDA product code for PCA +15MM MODULAR FEMORAL HEAD?

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

What is the regulatory pathway for PCA +15MM MODULAR FEMORAL HEAD?

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

PCA +15MM MODULAR FEMORAL HEAD

K955305 · Howmedica Corp. · MEH · Jan 18, 1996 · Orthopedic

Device Facts

Record ID	K955305
Device Name	PCA +15MM MODULAR FEMORAL HEAD
Applicant	Howmedica Corp.
Product Code	MEH · Orthopedic
Decision Date	Jan 18, 1996
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.