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 IDK965002
Device NameZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND
ApplicantEncore Orthopedics, Inc.
Product CodeLZO · Orthopedic
Decision DateJun 27, 1997
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3353
Device ClassClass 2
AttributesTherapeutic

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

Reference Devices

Related Devices

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 512 834 6340 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) ![img-0.jpeg](img-0.jpeg) Prescription Use ☑ (per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96)_
Innolitics
510(k) Summary
Decision Summary
Classification Order
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