SC CERAMIC BALL HEADS

K052237 · Orthopedic Alliance, LLC · LZO · Sep 6, 2005 · Orthopedic

Device Facts

• Record ID: K052237
• Device Name: SC CERAMIC BALL HEADS
• Applicant: Orthopedic Alliance, LLC
• Product Code: LZO · Orthopedic
• Decision Date: Sep 6, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SC Ceramic Ball Heads are indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-,rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries. The SC Femoral Hip Stem is indicated for use with or without bone cement. The SC Acetabular Cup is for use with bone cement only.

Device Story

SC Ceramic Ball Heads are orthopedic prosthetic components for total hip arthroplasty; part of the SC Total Hip System. Device provides additional sizing options (28mm and 32mm diameters in S, M, L lengths) for surgeons to address patient-specific anatomical needs. Used in clinical settings by orthopedic surgeons during hip replacement or revision procedures. Biomechanical testing confirms structural integrity for in vivo loading. Benefits include restoration of joint function and pain relief for patients with severe hip pathology.

Clinical Evidence

Bench testing only; biomechanical test results were equivalent to similar implants and sufficient for in vivo loading.

Technological Characteristics

Ceramic ball heads; semi-constrained hip prosthesis components. Available in 28mm and 32mm diameters. Designed for use with SC Total Hip System components (femoral stem and acetabular cup).

Indications for Use

Indicated for patients with severely disabled hip joints due to painful osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis, or requiring revision of previous hip surgeries.

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

• SC Total Hip System (K031474)

Submission Summary (Full Text)

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K052237 pge 191

SPECIAL 510(K) DEVICE MODIFICATION SC Ceramic Ball Heads August 16, 2005

## SEP - 6 2005

510(k) Summary of Safety and Effectiveness [in accordance with SMDA of 1990, 21 CFR 807.92(c)]

Contact: Mr. Hartmut Loch Director, Regulatory Affairs & Official FDA Correspondent Orthopedic Alliance, LLC 41558 Eastman Drive, Suite A Murrieta, CA 92562 Tel: [phone] Fax: [phone]

- Trade name: SC Ceramic Ball Heads
- Common name: Ceramic Ball Heads

Classification Hip Joint Metal/Ceramic/Polymer Semi-Constraint Cemented or Non-Porous Uncemented Prosthesis name:

Class II, Orthopedic Device Panel 87

Product Code: LZO

Device Description and Characteristics: We added 6 sizes, 28 S, 28 M, 28 L, 32 S, 32 M, and 32 L of ceramic ball heads to the SC Total Hip System, which was cleared for marketing by FDA on 10/15/03 (K031474). These ball heads allow the surgeon a further option to meet the patient's needs.

- Indications: The SC Ceramic Ball Heads are indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-,rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries. The SC Femoral Hip Stem is indicated for use with or without bone cement. The SC Acetabular Cup is for use with bone cement only.
Performance Biomechanical tests have been performed. The test results data: were equivalent to other similar implants and are sufficient for in vivo loading.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, and three horizontal lines above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2005

Mr. Hartmut Loch Director, Regulatory Affairs Orthopedic Alliance, LLC 41558 Eastman Drive, Suite A Murrieta, California 92562

Re: K052237 Trade/Device Name: SC Ceramic Ball Heads 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: August 16, 2005 Received: August 18, 2005

Dear Mr. Loch:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premium is substantially equivalent (for the indications relerenced above and nave determined with marketed predicate devices marketed in interstate for use stated in the enclosure) to tegans and the Medical Device Amendments, or to commerce prior to May 20, 1978, the exactions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Costlience Act (Act) that do not require appear al controls provisions of the Act. The Y ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (500 above) also Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FD a may be subject to subli additional controllations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Tcase be advised that I DA 3 issualse over device complies with other requirements of the Act that I D7 has made a acted regulations administered by other Federal agencies. You must of ally rederal statutes and regulations canning, but not limited to: registration and listing (21 comply with an the Aot 3 requirements, mort 801); good manufacturing practice requirements as set CI K I att 607), lubomig (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bytellio (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2- Mr. Hartmut Loch

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manieing of substantial equivalence of your device to a legally prematication. The PDA miaing of casification 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 if you desire specific advice for your ac not to career and and and and and of the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain. Milsbraining by reference to premaintentibilities under the Act from the Division of Small other general information on your responsive Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SPECIAL 5,10(K) DEVICE MODIFICATION SC Ceramic Ball Heads August 16, 2005

> 1 1 Page of

K052237 510(k) Number:

SC Ceramic Ball Heads Device Name(s):

Indications for Use:

The SC Ceramic Ball Heads are indicated for use in the treatment of severely disabled hip joints resulting from painful osteorheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries. The SC Femoral Hip Stem is indicated for use with or without bone cement. The SC Acetabular Cup is for use with bone cement only.

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

No Over-The-Counter-Use (21 CFR 801 Subpart C)

(2, 571, 581, Support, 3)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

51000 Number K052237