Who is the manufacturer of VITALITY HIP STEM?

Encore Orthopedics, Inc. filed the 510(k) submission for VITALITY HIP STEM (K962560).

What is the FDA product code for VITALITY HIP STEM?

JDI. It is classified under 21 CFR 888.3350 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for VITALITY HIP STEM?

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

What are the predicate devices for VITALITY HIP STEM?

Foundation Forged Cemented Stems (K952191); Foundation 9 mm Forged Stems (K961890); Lima Universal Stem (K885146); Lima Universal Stem (K910836).

Who can help prepare an FDA 510(k) submission like VITALITY HIP STEM?

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.

VITALITY HIP STEM

K962560 · Encore Orthopedics, Inc. · JDI · Sep 19, 1996 · Orthopedic

Device Facts

Record ID	K962560
Device Name	VITALITY HIP STEM
Applicant	Encore Orthopedics, Inc.
Product Code	JDI · Orthopedic
Decision Date	Sep 19, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3350
Device Class	Class 2
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.

Indications for Use

Indicated for patients requiring total or hemi-hip arthroplasty due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, revision of failed devices, or nonunion/fractures of the proximal femur.

Regulatory Classification

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)
Foundation 9 mm Forged Stems (K961890)
Lima Universal Stem (K885146)
Lima Universal Stem (K910836)

Related Devices

K030079 — VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS · Zimmer, Inc. · Feb 5, 2003
K984154 — APF POROUS COATED LINE EXTENSION · Biomet, Inc. · Feb 11, 1999
K041109 — ZIMMER ANATOMIC II HIP PROSTHESIS · Zimmer, Inc. · Jul 20, 2004
K964704 — DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM · Depuy, Inc. · Jan 24, 1997
K192236 — Fitmore Hip Stem · Zimmer GmbH · Nov 5, 2019

Submission Summary (Full Text)

{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.