← Product Code [LWJ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LWJ) · K964178 # PRESS-FIT HIP STEM (K964178) _Encore Orthopedics, Inc. · LWJ · May 5, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LWJ/K964178 ## Device Facts - **Applicant:** Encore Orthopedics, Inc. - **Product Code:** [LWJ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LWJ.md) - **Decision Date:** May 5, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3360 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Foundation® Press-Fit Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck 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. It is intended to be used press-fit. ## Device Story Foundation® Press-Fit Hip Stem; femoral component for total hip arthroplasty. Trapezoidal proximal body; conical distal stem with flutes for rotational stability; coronal slot for stiffness reduction. Features Morse taper for modular heads; 132° neck/stem angle. Implanted via press-fit technique by orthopedic surgeons in hospital setting. Provides stable femoral fixation; restores joint function; alleviates pain associated with degenerative or traumatic hip conditions. ## Clinical Evidence Bench testing only; laboratory testing conducted on Morse type taper. ## Technological Characteristics Material: wrought/forged Ti-6Al-4V; proximal plasma-sprayed surface for fixation. Geometry: trapezoidal proximal body, conical distal stem, 132° neck/stem angle. Features: distal flutes, coronal slot, Morse taper. Sterilization: not specified. ## 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} K964178 # Summary of Safety and Effectiveness Encore Orthopedics®, Inc. 8900 Shoal Creek Blvd. Building 300 Austin, TX 78757 512-795-8696 MAY - 5 1997 **Trade Name:** Foundation® Press-Fit Hip Stem **Common Name:** Press-fit hip stem **Classification Name:** Hip joint metal/polymer semi-constrained prosthesis **Description:** The proximal body is trapezoidal in cross-sectional geometry. The distal stem portion is conical in shape and has flutes to provide rotational stability. A coronal slot in the larger stems decreases implant stiffness. The stem is available with and without a calcar collar and has a Morse type taper to receive modular heads. The neck/stem angle is 132°. The Foundation® Press-Fit Hip Stem is fabricated from wrought/forged Ti-6Al-4V. The proximal body of the stem has a plasma sprayed surface to enhance press-fit fixation. **Intended Use:** The Foundation® Press-Fit Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck 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. It is intended to be used press-fit. **Comparable Features to Predicate Device(s):** Features comparable to predicate devices include Ti-6Al-4V substrate, straight stem, symmetric, calcar collar, no collar, distal fluted stem, modular heads and distal coronal slot.. **Test Results:** Laboratory testing of the Morse type taper was conducted. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LWJ/K964178](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LWJ/K964178) **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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