Who is the manufacturer of METAL ACETABULAR COMPONENT?

Encore Orthopedics, Inc. filed the 510(k) submission for METAL ACETABULAR COMPONENT (K964227).

What is the FDA product code for METAL ACETABULAR COMPONENT?

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

What is the regulatory pathway for METAL ACETABULAR COMPONENT?

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

Who can help prepare an FDA 510(k) submission like METAL ACETABULAR COMPONENT?

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.

METAL ACETABULAR COMPONENT

K964227 · Encore Orthopedics, Inc. · LPH · Jan 14, 1997 · Orthopedic

Device Facts

Record ID	K964227
Device Name	METAL ACETABULAR COMPONENT
Applicant	Encore Orthopedics, Inc.
Product Code	LPH · Orthopedic
Decision Date	Jan 14, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3358
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The metal backed acetabular component is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Device Story

Metal acetabular component for total hip arthroplasty; hemispherical Ti-6Al-4V shell with plasma-sprayed roughened surface and three spikes for press-fit fixation; ultra-high molecular weight polyethylene (UHMWPE) liners in neutral or 10° hooded configurations; used by orthopedic surgeons in clinical settings; device relieves hip pain and restores motion; hooded design addresses subluxation risk.

Clinical Evidence

Bench testing only; porous attachment strength of liners to shell evaluated; results sufficient for in-vivo loading.

Technological Characteristics

Materials: Ti-6Al-4V (wrought/forged or cast) shell, UHMWPE liners. Surface: Plasma-sprayed roughened exterior. Fixation: Press-fit with three spikes. Form factor: Hemispherical shell with neutral or 10° hooded liner options.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, femoral neck fracture, or revision arthroplasty with minimal bone loss. Hooded liner design indicated for patients prone to subluxation due to soft tissue laxity.

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.

Predicate Devices

DePuy 500 Series acetabular components

Related Devices

K963998 — METAL BACKED ACETABULAR COMPONENT · Encore Orthopedics, Inc. · Jan 27, 1997
K960633 — PRESS-FIT FLARED SHELL · Encore Orthopedics, Inc. · Oct 1, 1996
K961526 — PRESS-FIT POROUS SHELL · Encore Orthopedics, Inc. · Sep 17, 1996
K071784 — DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS · DePuy Orthopaedics, Inc. · Jul 25, 2007
K141043 — CS2 MULTI-HOLE ACETABULAR SHELL · Consensus Orthopedics, Inc. · May 19, 2014

Submission Summary (Full Text)

{0} JAN 14 1997 K96 4227 Summary of Safety and Effectiveness Encore Orthopedics®, Inc. 8900 Shoal Creek Blvd. Suite 300 Austin, TX 78759 (512) 206-1437 Ashley M. Bock Trade Name: Metal Acetabular Component Common Name: Metal acetabular component Classification Name: Hip joint metal/polymer semi-constrained press-fit prosthesis per 21 CFR 888.3350 Description: The hemispherical metal shell is fabricated from wrought/forged or cast Ti-6Al-4V. The outside surface of the shell is plasma sprayed to provide a roughened surface for press-fit enhanced fixation. The metal shell has three spikes to provide enhanced press-fit fixation. The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral and 10° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity. Intended Use: The metal backed acetabular component is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. Comparable Features to Predicate Device(s): The spherical shape, titanium substrate, indexability of liners in shell and bone screw holes are features that are comparable to other devices in commercial distribution. The outside surface of the shell is plasma sprayed to provide a roughened surface for enhanced fixation. The spikes are comparable to the DePuy 500 Series acetabular components. Test Results: Testing on this device included porous attachment strength of liners to shell. All results are sufficient for in-vivo loading.