Who is the manufacturer of PRESS-FIT FLARED SHELL?

Encore Orthopedics, Inc. filed the 510(k) submission for PRESS-FIT FLARED SHELL (K960633).

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

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

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

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

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

K960633 · Encore Orthopedics, Inc. · LWJ · Oct 1, 1996 · Orthopedic

Device Facts

Record ID	K960633
Device Name	PRESS-FIT FLARED SHELL
Applicant	Encore Orthopedics, Inc.
Product Code	LWJ · Orthopedic
Decision Date	Oct 1, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3360
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Press-fit Flared Shell 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 Flared Shell; metal-backed acetabular component for total hip arthroplasty. Device consists of hemispherical Ti-6Al-4V shell with textured exterior for press-fit fixation and optional 6.5mm cancellous bone screws for secondary fixation. Ultra-high molecular weight polyethylene (UHMWPE) liners available in neutral or 10° hooded designs; hooded design addresses subluxation risk from soft tissue laxity. Used by orthopedic surgeons in clinical settings to replace diseased/damaged acetabulum. Provides stable prosthetic interface to relieve hip pain and restore joint motion.

Clinical Evidence

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

Technological Characteristics

Materials: Ti-6Al-4V (wrought/forged or cast) shell; UHMWPE liners. Design: Hemispherical shell with textured exterior, rim flare, and 6.5mm cancellous bone screw holes. Liners: Neutral or 10° hooded. Fixation: Press-fit.

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 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.

Related Devices

K963998 — METAL BACKED ACETABULAR COMPONENT · Encore Orthopedics, Inc. · Jan 27, 1997
K964227 — METAL ACETABULAR COMPONENT · Encore Orthopedics, Inc. · Jan 14, 1997
K961526 — PRESS-FIT POROUS SHELL · Encore Orthopedics, Inc. · Sep 17, 1996
K141043 — CS2 MULTI-HOLE ACETABULAR SHELL · Consensus Orthopedics, Inc. · May 19, 2014
K973119 — FOUNDATION POROUS ACETABULAR SYSTEM · Encore Orthopedics, Inc. · Jan 28, 1998

Submission Summary (Full Text)

{0} K960633 OCT 1 1996 # 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:** Press-fit Flared Shell **Common Name:** Metal backed acetabular component **Classification Name:** Hip joint metal/polymer semi-constrained press-fit prosthesis per 21 CFR 888.3350 **Description:** The metal shell is fabricated from wrought/forged or cast Ti-6Al-4V. The outside surface of the shell is textured to provide a roughened surface for enhanced press-fit fixation. The metal shell is hemispherical in shape and is available with. The screw holes are for the use of 6.5 mm cancellous bone screws for secondary 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 Press-fit Flared Shell 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 textured to provide a roughened surface for enhanced press-fit fixation. The Encore Press-fit Flared Shell flares at the rim to enhance the press fit, with a straight line rather than a change in radius. **Test Results:** Testing on this device included porous attachment strength of liners to shell. All results are sufficient for in-vivo loading.