REDUCED SIZE ONCOLOGY SALVAGE SYSTEM

K021260 · Biomet, Inc. · KRO · Jun 5, 2002 · Orthopedic

Device Facts

• Record ID: K021260
• Device Name: REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
• Applicant: Biomet, Inc.
• Product Code: KRO · Orthopedic
• Decision Date: Jun 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3510
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Reduced Size Oncology Salvage System (OSS) offers a variety of component options for treatment in small adults and children that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibia and distal femur. Indications: 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis 2. Correction of varus, valgus, or post traumatic deformity 3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement 4. Ligament deficiencies 5. Tumor resections 6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques 7. Revision of previously failed total joint arthroplasty 8. Trauma These device components are for cemented use only.

Device Story

Reduced Size Oncology Salvage System (OSS) provides modular orthopedic implants for limb salvage in small adults and children. Components include femoral and tibial replacements and resurfacing elements. Device is surgically implanted by orthopedic surgeons in hospital settings to address complex bone loss from tumors, trauma, or failed prior arthroplasty. Implants are secured using bone cement. System allows for anatomical reconstruction, restoring joint function and stability, and potentially avoiding amputation in patients with significant skeletal pathology.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modular orthopedic prosthesis components for cemented fixation. Materials include metal and polymer. Designed for constrained femorotibial application. Regulatory class II, product code KRO.

Indications for Use

Indicated for small adults and children requiring proximal femoral, distal femoral, total femur, or proximal tibial replacements, or resurfacing of proximal tibia/distal femur due to joint pain/disability (necrosis, arthritis), deformity, failed prior surgery, ligament deficiency, tumor resection, non-unions, fractures, or trauma. For cemented use only.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Oncology Salvage System (K002757)

Submission Summary (Full Text)

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## SUMMMARY OF SAFETY AND EFFECTIVENESS

| Applicant or Sponsor: | Biomet Orthopedics, Inc. |
|-----------------------|--------------------------|
| | 56 East Bell Drive |
| | P.O. Box 587 |
| | Warsaw, IN 46581-0587 |

Contact Person: Sara B. Shultz Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587 Phone: [phone] Fax: [phone] Reduced Size Oncology Salvage System Proprietary Name: Oncology Salvage Hip, Knee, Tibia, Total Femur Common or Usual Name: Prosthesis, Knee, Femorotibial, constrained, Classification Name: cemented, metal/polymer (888.3510) Device Product Code: 87KRO

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Oncology Salvage System, K002757, Biomet, Inc.

Indications for Use: The Reduced Size Oncology Salvage System (OSS) offers a variety of component options for treatment in small adults and children that require proximal femoral. distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibia and distal femur.

Indications:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis

2. Correction of varus, valgus, or post traumatic deformity

3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement

4. Ligament deficiencies

5. Tumor resections

6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques

7. Revision of previously failed total joint arthroplasty

8. Trauma

..

These device components are for cemented use only.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 - - -

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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OFFICE 219.267.6639

FAX [phone]

E-MAIL [e-mail]

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 0 5 2002

Ms. Sara B. Shultz Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw. IN 46581-0587

Re: K021260

Trade Name: Reduced Size Oncology Salvage System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: April 18, 2002 Received: April 19, 2002

Dear Ms. Shultz:

We have reviewed your Section 510(k) premarket 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) 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 -- Ms. Sara B. Shultz

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

sincerely yours,

Mark McMahon

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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# 510 (k) Number (if known) :

Device Name: Reduced Size Oncology Salvage System

Indications For Use:

The Reduced Size Oncology Salvage System (OSS) offers a variety of component options for treatment in small adults and children that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibia and distal femur. Indications:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis

2. Correction of varus, valgus, or post traumatic deformity

3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement

4. Ligament deficiencies

5. Tumor resections

6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques

7. Revision of previously failed total joint arthroplasty

8. Trauma

These device components are for cemented use only.

Mark N. Milliken

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

KO21260 510(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

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)

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