OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM

K041443 · Osteoimplant Technology, Inc. · LZO · Nov 16, 2004 · Orthopedic

Device Facts

• Record ID: K041443
• Device Name: OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
• Applicant: Osteoimplant Technology, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Nov 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OTI Alumina Ceramic Femoral Head System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

Device Story

OTI Alumina Ceramic Femoral Head System is a line extension of orthopedic prosthetic components. Device functions as a replacement femoral head in total or partial hip arthroplasty. Used by orthopedic surgeons in clinical/hospital settings to restore hip joint function and alleviate pain in patients with structural hip damage. Device interfaces with existing femoral stems and acetabular components. Benefits include improved wear characteristics and biocompatibility associated with alumina ceramic materials compared to traditional metal-on-polyethylene options.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Alumina ceramic. Form factor: Femoral head prosthesis. Intended for use in hip joint arthroplasty. Design conforms to 21 CFR 888.3353.

Indications for Use

Indicated for patients requiring total or partial hip replacement due to severe pain/disability from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, femoral fractures, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, or previous fusion with inadequate bone stock.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

NOV 16 2004

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Sam Son
Vice President, Technical Affairs
Osteoimplant Technology, Inc.
11201 Pepper Road
Hunt Valley, Maryland 21031

Re: K041443
Trade Name: OTI Alumina Ceramic Femoral Head System – Line Extension
Regulation Number: 21 CFR 888.3353
Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Regulatory Class: II
Product Code: LZO
Dated: October 15, 2004
Received: October 18, 2004

Dear Mr. Son:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Sam Son

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,


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

Enclosure

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# Indications for Use

510 (k) Number (if known): K041443

Device Name: OTI Alumina Ceramic Femoral Head System – Line Extension

Indications for Use:

OTI Alumina Ceramic Femoral Head System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

Prescription Use ONLY

AND/OR

Over-The-Counter Use N/A
(21 CFR 801 Subpart C)

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