Who is the manufacturer of QUATROLOC FEMORAL COMPONENT & HEAD?

Whiteside Biomechanics, Inc. filed the 510(k) submission for QUATROLOC FEMORAL COMPONENT & HEAD (K961625).

What is the FDA product code for QUATROLOC FEMORAL COMPONENT & HEAD?

LPH. It is classified under 21 CFR 888.3358 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for QUATROLOC FEMORAL COMPONENT & HEAD?

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

Who can help prepare an FDA 510(k) submission like QUATROLOC FEMORAL COMPONENT & HEAD?

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.

QUATROLOC FEMORAL COMPONENT & HEAD

K961625 · Whiteside Biomechanics, Inc. · LPH · Sep 10, 1996 · Orthopedic

Device Facts

Record ID	K961625
Device Name	QUATROLOC FEMORAL COMPONENT & HEAD
Applicant	Whiteside Biomechanics, Inc.
Product Code	LPH · Orthopedic
Decision Date	Sep 10, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3358
Device Class	Class 2
Attributes	Therapeutic

Intended Use

This device is intended to be used for: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2. rheumatoid arthritis, 3. correction of functional deformity, 4. revision procedures where other treatments or devices have failed, and 5. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Device Story

Modular femoral hip prosthesis; wrought titanium 6Al-4V stem; rectangular cross-section; tapered proximal end; porous-coated with commercially pure titanium beads for uncemented fixation; distal stem smooth A-P taper with M-L step-cut. Intended for use with conventional cobalt-chrome modular femoral heads and acetabular implants. Surgeon-implanted in clinical setting to restore joint function in patients with degenerative disease, arthritis, or fractures. Provides stable femoral fixation via osseointegration of porous coating.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Wrought titanium 6Al-4V (ASTM F1472) stem; commercially pure titanium beads (-45+60Mesh) for porous coating (3 layers, 0.030" thickness). Design: Rectangular cross-section, tapered proximal end, distal smooth A-P taper, M-L step-cut. Sterilization: 100% ethylene oxide and nitrogen per AAMI guidelines.

Indications for Use

Indicated for patients requiring hip arthroplasty due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, revision surgery, or proximal femur fractures (femoral neck/trochanteric) with head involvement where other treatments failed.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Related Devices

K974294 — ENCORE LINEAR POROUS COATED HIP · Encore Orthopedics, Inc. · Jan 12, 1998
K964616 — QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT · Whiteside Biomechanics, Inc. · Aug 7, 1997
K042337 — ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING · Zimmer, Inc. · Nov 4, 2004
K991325 — MODIFICATION OF ENCORE LINEAR POROUS COATED HIP · Encore Orthopedics, Inc. · Jun 25, 1999
K030079 — VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS · Zimmer, Inc. · Feb 5, 2003

Submission Summary (Full Text)

{0} SEP 10 1996 K961625 510(k) SUMMARY ## Device: Classification Name: Prosthesis Hip, Semi-constrained, Metal / Polymer, Porous Uncemented Classification No.: 87LPH Common / Usual Name: Modular femoral component and head Proprietary Name: Quatroloc Femoral Component and Head ## Manufacturer Identification: Whiteside Biomechanics, Inc. 12634 Olive Blvd. Creve Coeur, MO 63141 Establishment Registration Number: 1932213 ## Device Description: The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6Al- 4V (ASTM 1472) stem with a tapered proximal end intended to seat a conventional cobalt-chrome modular spheric articular interface. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. The distal will be a smooth taper A-P and will be step-cut with parallel sides M-L. The proximal stem will be porous coated with commercially pure titanium beads on all surfaces excluding the articular interface trunnion. ## Intended Use: This device is intended to be used for: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2. rheumatoid arthritis, 3. correction of functional deformity, 4. revision procedures where other treatments or devices have failed, and 5. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. ## Additional Information: This femoral component is made of wrought titanium 6Al-4V (ASTM F1472). The proximal portion of the stem will be porous coated on all surfaces, excluding the ball trunnion. The porous coating will consist of 3 layers (0.030" total thickness) of commercially pure titanium beads (-45+60Mesh). The device is to be sterilized with 100% ethylene oxide and nitrogen in accordance with AAMI guidelines for sterilization.