← Product Code [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI) · K962560

# VITALITY HIP STEM (K962560)

_Encore Orthopedics, Inc. · JDI · Sep 19, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K962560

## Device Facts

- **Applicant:** Encore Orthopedics, Inc.
- **Product Code:** [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI.md)
- **Decision Date:** Sep 19, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3350
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The Vitality Hip stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty. The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments where devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended to be used with cement with acetabular components or with unipolar, bipolar and CoCrMo femoral heads.

## Device Story

Vitality Hip Stem; rectangular cross-section; proximal-to-distal and lateral-to-medial taper; forged CoCrMo alloy; grit-blasted proximal surface (4-6 µm); optional calcar collar; Morse taper for modular head attachment. Used in total or hemi-hip arthroplasty; implanted by orthopedic surgeons. Device provides structural replacement for femoral head/neck; restores joint function; facilitates fixation via bone cement. Modular design allows compatibility with various acetabular components and femoral heads.

## Clinical Evidence

Bench testing only. Laboratory testing of Morse taper and theoretical stress analysis performed.

## Technological Characteristics

Material: Forged CoCrMo alloy. Geometry: Rectangular cross-section, tapered. Surface: Grit-blasted proximal body (4-6 µm). Connection: Morse taper. Neck/stem angle: 130° (sizes 1-2), 132° (sizes 3-6). Fixation: Cemented.

## Regulatory Identification

A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

## Predicate Devices

- Foundation Forged Cemented Stems ([K952191](/device/K952191.md))
- Foundation 9 mm Forged Stems ([K961890](/device/K961890.md))
- Lima Universal Stem ([K885146](/device/K885146.md))
- Lima Universal Stem ([K910836](/device/K910836.md))

## Submission Summary (Full Text)

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{0}

SEP 19 1996

Summary of Safety and Effectiveness

K962560

Encore Orthopedics®, Inc.
8900 Shoal Creek Bldg 300
Austin, TX 78757
512-206-1437
June 28, 1996
Ashley M. Bock

Trade Name: Vitality Hip Stem

Common Name: Cemented total hip

Classification Name: Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3350

Description: The Vitality Hip Stem is rectangular in cross-sectional geometry and tapers proximal to distal and lateral to medial. The proximal half of the body of the femoral stem is grit blasted to a surface of 4-6 µm. This device is fabricated from forged CoCrMo alloy.

The Foundation Vitality Hip Stem is available with and without a calcar collar and has a Morse type taper to receive modular heads. The neck/stem angle is 130° for sizes 1-2 and 132° for sizes 3-6.

Indications for Use: The Vitality Hip stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty. The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments where devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.

It is intended to be used with cement with acetabular components or with unipolar, bipolar and CoCrMo femoral heads.

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the Foundation® Forged Cemented Stems (K952191), Foundation® 9 mm Forged Stems (K961890), CoCrMo substrate, calcar collar, roughened proximal body, modular heads, bipolar and unipolar heads. The design is comparable to the predicate device the Lima Universal Stem(K885146, K910836).

Test Results: Laboratory testing of the Morse type taper was conducted. Theoretical testing of the maximum stresses was compared to the Foundation® 9 mm Forged Stem.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K962560](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K962560)

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