R120 MODULAR TOTAL HIP SYSTEM

K011774 · Osteoimplant Technology, Inc. · JDI · Sep 5, 2001 · Orthopedic

Device Facts

• Record ID: K011774
• Device Name: R120 MODULAR TOTAL HIP SYSTEM
• Applicant: Osteoimplant Technology, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Sep 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The R120™ Modular Total Hip System is indicated for use in total or partial hip replacement The X120 - Northering sovere pain and disability due to structural damage in the hip joint from rheumatoid atthritis, 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 opplysis, that encation a. The Total Hip System is intended for use with and without bone cement.

Device Story

R120™ Modular Total Hip System; orthopedic implant for total or partial hip arthroplasty. System components replace damaged hip joint structures to alleviate pain and restore function. Used in surgical settings by orthopedic surgeons. Implantable device; intended for use with or without bone cement. Provides structural support for patients with degenerative joint disease or trauma-related hip conditions.

Clinical Evidence

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

Technological Characteristics

Modular total hip system; components designed for use with or without bone cement. Class II device (888.3050, 888.3358).

Indications for Use

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

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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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2001

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

Re: K011774

Trade/Device Name: R120™ Modular Total Hip System Regulation Number: 888.3050, 888.3358 Regulatory Class: II Product Code: JDI, LPH Dated: June 5, 2001 Received: June 7, 2001

Dear Mr. Son:

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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 regulations.

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Page 2 - Mr. Sam Son

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be 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/dsma/dsmamain.html".

Sincerely yours,

Lisa Walker, MP
for

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

Enclosure

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KO11724 510(k) Number (if known)______________________________________________________________________________________________________________________________________________________

Device Name: R120™ MODULAR TOTAL HIP SYSTEM

## Indications For Use:

The R120™ Modular Total Hip System is indicated for use in total or partial hip replacement The X120 - Northering sovere pain and disability due to structural damage in the hip joint from rheumatoid atthritis, 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 opplysis, that encation a. The Total Hip System is intended for use with and without bone cement.

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Conourrence of CDRH, Office of Device Evaluation (ODF)

Lisa Walker, M.D.

(Division Sign-Off) Division of Goneral Restorative Devices 510(k) Number 1011

Proscription Use (Par 21 CFR 801.109) OR.

Over-The-Counter Uso _

(Optional Formal 1-2-96)