Who is the manufacturer of PRESS-FIT POROUS SHELL?

Encore Orthopedics, Inc. filed the 510(k) submission for PRESS-FIT POROUS SHELL (K961526).

What is the FDA product code for PRESS-FIT POROUS SHELL?

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

What is the regulatory pathway for PRESS-FIT POROUS SHELL?

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

Who can help prepare an FDA 510(k) submission like PRESS-FIT POROUS SHELL?

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.

PRESS-FIT POROUS SHELL

K961526 · Encore Orthopedics, Inc. · LPH · Sep 17, 1996 · Orthopedic

Device Facts

Record ID	K961526
Device Name	PRESS-FIT POROUS SHELL
Applicant	Encore Orthopedics, Inc.
Product Code	LPH · Orthopedic
Decision Date	Sep 17, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3358
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Press-fit Porous 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

Press-fit porous acetabular component for total hip arthroplasty; hemispherical Ti-6Al-4V metal shell with commercially pure titanium bead porous coating for fixation; optional 6.5 mm cancellous bone screws for adjunct fixation; ultra-high molecular weight polyethylene liners in neutral or 10° hooded designs; hooded design addresses subluxation risk from soft tissue laxity; surgeon-implanted in clinical setting; restores hip motion and relieves pain.

Clinical Evidence

Bench testing only; includes porous coating, tensile strength, shear strength, and liner-to-shell attachment strength testing; results demonstrate sufficiency for in-vivo loading.

Technological Characteristics

Materials: Ti-6Al-4V shell, commercially pure titanium bead porous coating, ultra-high molecular weight polyethylene liners. Design: Hemispherical shell, 12° screw angulation. Fixation: Press-fit with optional 6.5 mm cancellous screws.

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.

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

K963998 — METAL BACKED ACETABULAR COMPONENT · Encore Orthopedics, Inc. · Jan 27, 1997
K964227 — METAL ACETABULAR COMPONENT · Encore Orthopedics, Inc. · Jan 14, 1997
K960633 — PRESS-FIT FLARED SHELL · Encore Orthopedics, Inc. · Oct 1, 1996
K973119 — FOUNDATION POROUS ACETABULAR SYSTEM · Encore Orthopedics, Inc. · Jan 28, 1998
K071784 — DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS · DePuy Orthopaedics, Inc. · Jul 25, 2007

Submission Summary (Full Text)

{0} SEP 17 1998 K961526 # Summary of Safety and Effectiveness Encore Orthopedics®, Inc. 8900 Shoal Creek Blvd. Suite 300 Austin, TX 78757 512-206-1437 Ashley M. Bock **Trade Name:** Foundation® Porous Press-fit Acetabular Component **Common Name:** Press-fit Porous Shell **Classification Name:** Hip joint metal/polymer semi-constrained non-cemented prosthesis **Description:** The metal shell is fabricated from wrought/forged or cast Ti-6Al-4V. The outside surface of the shell is porous coated with commercially pure titanium beads to provide a porous surface for enhanced press-fit fixation. The metal shell is hemispherical in shape and is available with and without screw holes. The screw holes are for the use of 6.5 mm cancellous bone screws for adjunct fixation. The geometry of the screw holes is such that a 12° angulation of the screws is possible. 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 Press-fit Porous 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 and beaded coating, indexability of liners in shell and bone screw holes are features that are comparable to other devices in commercial distribution. **Test Results:** Testing on this device included porous coating, tensile and shear strength, and attachment strength of liners to shell. All results are sufficient for in-vivo loading.