ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND

K965002 · Encore Orthopedics, Inc. · LZO · Jun 27, 1997 · Orthopedic

Device Facts

• Record ID: K965002
• Device Name: ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND
• Applicant: Encore Orthopedics, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 or 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.

Device Story

Zirconia ceramic femoral head component for total hip arthroplasty; designed for articulation with cobalt-chrome or Ti6Al4V alloy hip stems featuring Cerasiv taper trunnions. Device replaces natural femoral head to restore joint function. Used in clinical settings by orthopedic surgeons during hip replacement or revision surgery. Benefits include material properties of zirconia ceramic for hip joint reconstruction.

Clinical Evidence

No clinical data provided; substantial equivalence based on material and design comparison to predicate devices.

Technological Characteristics

Zirconia ceramic femoral head; intended for use with cobalt-chrome or Ti6Al4V alloy hip stems with Cerasiv taper trunnions. Class II device (LZO).

Indications for Use

Indicated for patients requiring total hip replacement due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, failed prior treatments/devices, or nonunion/fractures of the proximal femur with head involvement.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Zimmer zirconia heads (K944601)
• DuPuy zirconia heads (K926395)
• Smith and Nephew Richards, Inc. zirconia heads (K935921)

Reference Devices

• Foundation Forged Stem (K952191)
• Foundation Textured Stem (K935263)
• Foundation Porous Stem (K952297)
• Encore Vitality Stem (K962560)
• SL and SLR PLUS Hip Stems (K932481)

Submission Summary (Full Text)

{0}

K965002
Summary of Safety and Effectiveness
JUN 27 1997

Encore Orthopedics™, Inc.
8900 Shoal Creek
Bldg. 300
Austin, TX 78757
512-795-8696
Ashley M. Bock

Trade Name: Zirconia ceramic heads for use with Encore® Vitality™, SL and SLR PLUS, and Foundation™ Forged, Textured and Porous Stems.

Common Name: Ceramic femoral head

Classification Name: Hip joint metal/ceramic/polymer semi-constrained cemented prosthesis per 21 CFR 888.3353, (LZO).

Description: Zirconia ceramic heads for use with Foundation® Forged (K952191), Textured (K935263) and Porous Stems (K952297), the Encore® Vitality™ Stem (K962560) and the SL and SLR PLUS (K932481) Hip Stems which have been cleared for commercial distribution.

Indications for Use: The indications for use of the total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or 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.

Comparable Features to Predicate Device(s): The Zirconia ceramic heads to be used with Foundation® Forged, Textured and Porous Stems, the Encore® Vitality™ Stem and SL and SLR PLUS Hip Stems are equivalent in material, design and clinical indications to the zirconia heads also manufactured by Demarquest for Zimmer (K944601), DuPuy (K926395), and Smith and Nephew Richards, Inc. (K935921).

{1}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Ashley M. Bock
Regulatory Specialist
Encore Orthopedics, Inc.
9800 Metric Boulevard
Austin, Texas 78758

Re: K965002
Zirconia Ceramic Femoral Heads for use with the Foundation Forged, Textured, and Porous Stems, the Encore Vitality Stem, and SL and SLR PLUS Hip Stems
Regulatory Class: II
Product Code: LZO
Dated: April 15, 1997
Received: April 17, 1997

Dear Ms. Bock:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation that the package insert must reflect that the Zirconia Ceramic Femoral Heads for use with the Foundation Forged, Textured, and Porous Stems, the Encore Vitality Stem, and SL and SLR PLUS Hip Stems are to be used only with cobalt-chrome and Ti6Al4V alloy hip stems with the Cerasiv taper trunnions.

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

{2}

Page 2 - Ms. Ashley M. Bock

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 600 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the *Federal Register*. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be

{3}

Page 3 - Ms. Ashley M. Bock

obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Marie Aflundele, MS, PT
for
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{4}

08/23/97 MON 15:48 FAX [phone]
ENCORE ORTHOPEDIC
002

510(k) Number (if known): K965002

Device Name: Encore Zirconia Femoral Heads

Indications For Use:

# Encore® Zirconia Heads
## Indications For Use

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 or 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑ (per 21 CFR 801.109)
OR
Over-The-Counter Use ☐
(Optional Format 1-2-96)_