AVALON CUP SYSTEM

K011887 · Orthopedic Source, Inc. · JDI · Dec 27, 2001 · Orthopedic

Device Facts

• Record ID: K011887
• Device Name: AVALON CUP SYSTEM
• Applicant: Orthopedic Source, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Dec 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indication: for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following: - 1) Non-inflammatory degenerative joint disease including: osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia, - 2) Inflammatory degenerative joint disease including rheumatoid arthritis; - 3) Correction of functional deformity; - 4) Revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Story

The Avalon Cup System is a hip prosthesis used in total hip arthroplasty. It is designed to replace the hip joint to reduce pain and improve function in patients with degenerative joint disease or fractures. The system is intended for use by orthopedic surgeons in a clinical/surgical setting. It functions as a mechanical implant to restore joint mobility and stability. The device provides a structural replacement for the femoral head and acetabulum, facilitating patient recovery and improved quality of life.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device design and intended use comparisons.

Technological Characteristics

Semi-constrained hip prosthesis system. Materials include metal, polymer, and ceramic components. Designed for cemented or non-porous, uncemented application. Classified under 21 CFR 888.3350 and 888.3353.

Indications for Use

Indicated for skeletally mature patients undergoing total hip arthroplasty for pain relief or improved function due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, revision of failed treatments, or nonunion/femoral neck 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).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 7 2001

Mr. Steven L. Mandell President Orthopedic Source, Inc. P.O. Box 307 Loomis, California 95650

Re: K011887

Trade/Device Name: Avalon Cup System Regulation Number: 21 CFR 888.3350; 888.3353 Regulation Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented and Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented Regulatory Class: Class II Product Code: JDI, LWJ, LZO Dated: October 30, 2001 Received: November 7, 2001

Dear Mr. Mandell:

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 (OS) 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. Steven L. Mandell

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you'll finding of substantial equivalence of your device to a legally premaired notification. "The suits 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 and 11 you desire specific art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 211 ) 594-4659. Additionally, for questions on the promotion and advertising of Compinatee at (301) 59 - 4 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general 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,

Mark n-Mullins

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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page 1 of 1

510(k) Number (if known):

Device Name: The Avalon Cup System

Indication for Use:

Indication: for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following:

<011887

- 1) Non-inflammatory degenerative joint disease including: osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia,
- 2) Inflammatory degenerative joint disease including rheumatoid arthritis;
- 3) Correction of functional deformity;
- 4) Revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck fractures of the proximal femur with head involvement that are unmanageable using other techniques.

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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)

Mark N. Millerson

K01188

Division Sign-Off) vision of General, Restorative and Neurological Devices

iii 510(k) Number _