Who is the manufacturer of PERFECTA REVISION HIP SYSTEM?

Wrightmedicaltechnologyinc filed the 510(k) submission for PERFECTA REVISION HIP SYSTEM (K955553).

What is the FDA product code for PERFECTA REVISION HIP SYSTEM?

LWJ. It is classified under 21 CFR 888.3360 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for PERFECTA REVISION HIP SYSTEM?

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

What are the predicate devices for PERFECTA REVISION HIP SYSTEM?

PERFECTA® Hip System (Orthomet/Wright Medical Technology, Inc.); Osteonics® Arc Depositioned Femoral Components.

Who can help prepare an FDA 510(k) submission like PERFECTA REVISION HIP SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PERFECTA REVISION HIP SYSTEM

K955553 · Wrightmedicaltechnologyinc · LWJ · Oct 24, 1996 · Orthopedic

Device Facts

Record ID	K955553
Device Name	PERFECTA REVISION HIP SYSTEM
Applicant	Wrightmedicaltechnologyinc
Product Code	LWJ · Orthopedic
Decision Date	Oct 24, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3360
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 wire arc spray coating. Available in straight or bowed configurations; features calcar platform and coronal slot (select sizes). Designed for press-fit or cemented fixation. Used by orthopedic surgeons in clinical/OR settings to replace diseased or damaged hip joints. Provides structural support for hip function; aids pain relief and mobility restoration.

Clinical Evidence

Bench testing only. Fatigue strength testing performed. Coating performance evaluated via weight loss comparison against sintered bead control specimens under comparable load ranges.

Technological Characteristics

Material: Titanium alloy (ASTM F-136). Coating: Titanium alloy wire arc 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 for pain reduction, relief, or improved hip function.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

PERFECTA® Hip System (Orthomet/Wright Medical Technology, Inc.)
Osteonics® Arc Depositioned Femoral Components

Related Devices

K962267 — PERFECTA PS REVISION STEM · Wrightmedicaltechnologyinc · Sep 10, 1996
K964218 — PERFECTA PLASMA SPRAY HIP STEM · Wrightmedicaltechnologyinc · Jan 8, 1997
K150302 — PROFEMUR Preserve Classic Stem · Microport Orthopedics, Inc. · Apr 10, 2015
K961589 — APR FULLY TEXTURED HIP STEM · Intermedics Orthopedics · Jul 9, 1996
K130984 — PROFEMUR RENAISSANCE CLASSIC HIP STEM · Wrightmedicaltechnologyinc · May 24, 2013

Submission Summary (Full Text)

{0} OCT 24 1996 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD ARLINGTON, TN 38002 901-867-9971 Contact Person: Cliff Kline Date: September 13, 1995 K955553 510(k) SUMMARY Trade/Proprietary Name: PERFECTA® Revision Hip System Common Name: Wire Spray Coated Femoral Hip Stem Classification: Class II Predicate Device: PERFECTA® Hip System by Orthomet, a division of Wright Medical Technology, Inc. and the Osteonics® Arc Depositioned Femoral Components 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 alloy wire arc 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 for 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® Revision Hip System is substantially equivalent to the PERFECTA® Hip System by Orthomet, a division of Wright Medical Technology, Inc. and the Osteonics® Arc Depositioned Femoral Components ## Testing The PERFECTA® Revision Hip System demonstrates acceptable fatigue strength. In addition the titanium wire arc spray coating demonstrates less weight loss as compared to the sintered bead control specimen through a comparable range of loads. 000229