Who is the manufacturer of ULTIMA SIZE 0 CEMENTED FEMORAL STEM?

Johnson & Johnson Professionals, Inc. submitted the Traditional clearance for ULTIMA SIZE 0 CEMENTED FEMORAL STEM (K953200).

What is the FDA product code for ULTIMA SIZE 0 CEMENTED FEMORAL STEM?

JDI. It is classified under 21 CFR 888.3350 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for ULTIMA SIZE 0 CEMENTED FEMORAL STEM?

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

ULTIMA SIZE 0 CEMENTED FEMORAL STEM

K953200 · Johnson & Johnson Professionals, Inc. · JDI · Jan 31, 1996 · Orthopedic

Device Facts

Record ID	K953200
Device Name	ULTIMA SIZE 0 CEMENTED FEMORAL STEM
Applicant	Johnson & Johnson Professionals, Inc.
Product Code	JDI · Orthopedic
Decision Date	Jan 31, 1996
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 888.3350
Device Class	Class 2

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).