K Number
K962560
Device Name
VITALITY HIP STEM
Date Cleared
1996-09-19

(80 days)

Product Code
Regulation Number
888.3350
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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 um. 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.
More Information

No
The summary describes a mechanical hip implant and does not mention any software, algorithms, or AI/ML capabilities.

Yes.
The device is intended for the treatment of various hip conditions, including degenerative joint disease, rheumatoid arthritis, fractures, and for revision procedures, all of which aim to restore function and alleviate symptoms.

No

Explanation: The Vitality Hip Stem is an implantable prosthetic device intended for use in total or hemi-hip arthroplasty, which is a treatment procedure. It does not identify, assess, or monitor diseases or conditions.

No

The device description clearly states it is a physical hip stem fabricated from forged CoCrMo alloy, which is a hardware component.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Device Description and Intended Use: The provided text describes a Vitality Hip stem, which is a surgical implant used in hip replacement surgery. It is a physical device implanted into the body to replace a damaged hip joint.
  • Lack of Diagnostic Activity: The description focuses on the physical characteristics of the implant and its intended use in treating conditions affecting the hip joint. There is no mention of testing samples, analyzing biological markers, or providing diagnostic information.

Therefore, based on the provided information, the Vitality Hip stem is a surgical implant, not an In Vitro Diagnostic device.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

Not Found

Device 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 um. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip, femoral

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K952191, K961890, K885146

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K910836

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.

0

K962560

Summary of Safety and Effectiveness

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 um. 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.