Who is the manufacturer of PERFECTA PS REVISION STEM?

Wrightmedicaltechnologyinc submitted the Traditional clearance for PERFECTA PS REVISION STEM (K962267).

What is the FDA product code for PERFECTA PS REVISION 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 PERFECTA PS REVISION STEM?

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

What are the predicate devices for PERFECTA PS REVISION STEM?

PERFECTA® Hip System (K962267); PERFECTA® Revision Hip System (K962267); Integral Total Hip System (Biomet).

PERFECTA PS REVISION STEM

K962267 · Wrightmedicaltechnologyinc · JDI · Sep 10, 1996 · Orthopedic

Device Facts

Record ID	K962267
Device Name	PERFECTA PS REVISION STEM
Applicant	Wrightmedicaltechnologyinc
Product Code	JDI · Orthopedic
Decision Date	Sep 10, 1996
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 888.3350
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The PERFECTA® Revision Hip System is intended to be used in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Device Story

Monolithic femoral component for total hip arthroplasty; titanium alloy (ASTM F-136) construction with plasma spray coating; available in straight or bowed configurations; features calcar platform and coronal slot (select sizes); press-fit or cemented implantation; used by orthopedic surgeons in clinical/OR settings; provides structural support for hip joint reconstruction; benefits patients via pain relief and improved joint function.

Clinical Evidence

Bench testing only. Abrasion testing demonstrates plasma spray coating comparability to sintered bead coating. Fatigue testing confirms device withstands simulated in vivo loading.

Technological Characteristics

Material: Titanium alloy (ASTM F-136). Coating: Titanium plasma spray. Design: Monolithic femoral stem, straight or bowed, with calcar platform and coronal slot. Fixation: Press-fit or cemented. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients undergoing total hip arthroplasty requiring pain reduction, relief, or improved hip function.

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).

Predicate Devices

PERFECTA® Hip System (K962267)
PERFECTA® Revision Hip System (K962267)
Integral Total Hip System (Biomet)

Related Devices

K955553 — PERFECTA REVISION HIP SYSTEM · Wrightmedicaltechnologyinc · Oct 24, 1996
K964218 — PERFECTA PLASMA SPRAY HIP STEM · Wrightmedicaltechnologyinc · Jan 8, 1997
K150302 — PROFEMUR Preserve Classic Stem · Microport Orthopedics, Inc. · Apr 10, 2015
K130984 — PROFEMUR RENAISSANCE CLASSIC HIP STEM · Wrightmedicaltechnologyinc · May 24, 2013
K042337 — ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING · Zimmer, Inc. · Nov 4, 2004

Submission Summary (Full Text)

{0} SENT BY: 9-8-96 :11:05AM :WRIGHT MEDICAL TECH. 301 594 2358;# 3/ 3 K962267 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD ARLINGTON, TN 38002 901-867-9971 SEP 10 1996 Contact Person: Cristie Manuel Date: September 8, 1996 # 510(k) Summary Trade/Proprietary Name: PERFECTA® PS Revision Hip Stem 510(k) Number: K962267 Common Name: Plasma Spray Coated Femoral Hip Stem Classification: Class II Predicate Devices: PERFECTA® Hip System and PERFECTA® Revision Hip System manufactured by Wright Medical Technology, Inc. and Integral Total Hip System manufactured by Biomet This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. ## Description/Intended Use The PERFECTA® Revision Hip System is a monolithic design femoral component. The device is manufactured from titanium alloy (ASTM F-136) with a titanium plasma spray coating. The stem is available in two configurations: straight and bowed. All configurations have a calcar platform, from 2.0cm to 3.75cm. All sizes except the 12mm x 190mm have a coronal slot. The stem is designed to be press-fit or can be used with bone cement. The PERFECTA® Revision Hip System is intended to be used in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. ## Substantial Equivalence The PERFECTA® PS Revision Hip Stem is substantially equivalent to the PERFECTA® Hip System and the PERFECTA® Revision Hip System manufactured by Wright Medical Technology, Inc. and the Integral Total Hip System manufactured by Biomet. ## Testing - Submitted abrasion testing demonstrates that the plasma spray porous coating is comparable to sintered bead coating. - Submitted fatigue testing demonstrates that the PERFECTA® PS Revision Hip Stem was able to withstand test loading designed to simulate in vivo loading.