← Product Code [LWJ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LWJ) · K960633 # PRESS-FIT FLARED SHELL (K960633) _Encore Orthopedics, Inc. · LWJ · Oct 1, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LWJ/K960633 ## Device Facts - **Applicant:** Encore Orthopedics, Inc. - **Product Code:** [LWJ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LWJ.md) - **Decision Date:** Oct 1, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3360 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LWJ/K960633](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LWJ/K960633) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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