HEADLOC CERAMIC FEMORAL HEADS

K971435 · Ortho Development Corp. · LZO · Jul 9, 1997 · Orthopedic

Device Facts

• Record ID: K971435
• Device Name: HEADLOC CERAMIC FEMORAL HEADS
• Applicant: Ortho Development Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Jul 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Headloc™ Ceramic Femoral Head for the Primaloc™ Cementless Hip System is intended for single-use cementless implantation during primary revision surgery. The Ceramic Head allows for primary articulation between the acetabular cup and femoral stem to restore patient mobility. Indications for use are: - Osteoarthritis, rheumatoid arthritis, or other osteoarthroses; - Certain femoral neck fractures or dislocations; - Post-traumatic arthritis: - Idiopathic avascular necrosis of the femoral head; - Benign or malignant bone tumors where sufficient bone stock exists to seat the prosthesis; - Previous failed surgery; - Total hip replacement where the surgeon indicates a ceramic head

Device Story

Headloc™ Ceramic Femoral Heads (Alumina or Zirconia) serve as prosthetic components for total hip replacement. Device functions as articulating surface between acetabular cup and femoral stem to restore patient mobility. Used in primary or revision surgery; implanted by orthopedic surgeons. Alumina heads restricted to CoCrMo alloy hip stems with CeramTec 2°52'30" Morse taper trunnions; Zirconia heads restricted to CoCrMo or Ti6Al4V alloy hip stems with same trunnion specifications. Device provides mechanical articulation to replace diseased or damaged femoral head.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material specifications.

Technological Characteristics

Materials: Alumina ceramic or Zirconia ceramic. Interface: CeramTec 2°52'30" Morse taper trunnion. Compatibility: Alumina heads for CoCrMo alloy stems; Zirconia heads for CoCrMo or Ti6Al4V alloy stems. Form factor: Femoral head prosthesis.

Indications for Use

Indicated for patients requiring total hip replacement due to osteoarthritis, rheumatoid arthritis, other osteoarthroses, femoral neck fractures/dislocations, post-traumatic arthritis, idiopathic avascular necrosis, bone tumors with sufficient bone stock, or previous failed surgery.

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.

Reference Devices

• Primaloc™ Cementless Hip System (K953977)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol J. Freasier Requlatory Affairs/Quality Assurance Specialist Ortho Development Corporation 106 West Business Park Drive JUL - 9 1007 Draper, Utah 84020

Re : K971435 Headloc™ Alumina and Zirconia Ceramic Heads Regulatory Class: II Product Code: LZO Dated: April 16, 1997 Received: April 18, 1997

Dear Ms. Freasier:

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 Headloc™ Alumina Ceramic Femoral Heads are to be used only with CoCrMo alloy hip stems with the CeramTec 2°52'30" Morse taper trunnions, and Headloc™ Zirconia Ceramic Femoral Heads are to be used only with CoCrMo or Ti6Al4V alloy hip stems with the CeramTec 2°52'30" Morse 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.

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Page 2 - Ms. Carol J. Freasier

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 Requlations, Title 21, Parts 800 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 Requlations.

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

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Page 3 - Ms. Carol J. Freasier

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,

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

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Ortho Development Corporation Premarket Notification for Headloc™ Ceramic Femoral Heads 510(k) Number (if known): K971426

Device Name: Headloc™Ceramic Femoral Head

## Indications for Use

The Headloc™ Ceramic Femoral Head for the Primaloc™ Cementless Hip System is intended for single-use cementless implantation during primary revision surgery. The Ceramic Head allows for primary articulation between the acetabular cup and femoral stem to restore patient mobility. Indications for use are:

- Osteoarthritis, rheumatoid arthritis, or other osteoarthroses;
- Certain femoral neck fractures or dislocations;
- Post-traumatic arthritis:
- Idiopathic avascular necrosis of the femoral head;
- Benign or malignant bone tumors where sufficient bone stock exists to seat the prosthesis;
- Previous failed surgery;
- Total hip replacement where the surgeon indicates a ceramic head

The Headloc™ Ceramic Head may be used with the Primaloc™ Cemetless Hip System which is cleared for use under Premarket Notification K953977.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

J. Costello

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K971435

Prescription Use X

OR

Over-The-Counter Use

(Optional Format 1-2-96)