HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS

K060360 · Howmedica Osteonics Corp. · KRO · Mar 15, 2006 · Orthopedic

Device Facts

• Record ID: K060360
• Device Name: HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS
• Applicant: Howmedica Osteonics Corp.
• Product Code: KRO · Orthopedic
• Decision Date: Mar 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3510
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modular Rotating Hinge Knee is intended to be implanted with bone cement for the following conditions: - There is destruction of the joint surfaces, with or without significant bone deformity. - The cruciate and/or collateral ligaments do not stabilize the knee joint. - The ligaments are inadequate and/or the musculature is weak. - Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

Device Story

Modular Rotating Hinge Knee with Offset Adapters; orthopedic implant system for total knee arthroplasty. Device components implanted with bone cement to replace destroyed joint surfaces and provide stability in cases of ligamentous insufficiency or failed prior prostheses. Offset adapters allow for modular adjustment during surgical implantation. Used in clinical/surgical settings by orthopedic surgeons. Provides mechanical structural support to restore knee joint function and stability; benefits patient by addressing gross instability and bone/soft tissue loss.

Clinical Evidence

Bench testing only. Engineering analysis demonstrated mechanical properties comparable to predicate devices.

Technological Characteristics

Modular knee prosthesis; metal/polymer constrained cemented design. Includes offset adapters for modularity. Materials and operational principles consistent with predicate knee systems.

Indications for Use

Indicated for patients requiring knee joint replacement due to joint surface destruction (with/without deformity), ligamentous instability (cruciate/collateral), inadequate musculature, or revision of failed prosthesis with gross instability and/or bone loss/soft tissue deficiency.

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

• Howmedica Osteonics® Modular Rotating Hinge Knee (K000500)
• Howmedica Total Stabilizer Knee Components

Submission Summary (Full Text)

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K060360

p. 1/2

### MAR 1 5 2006 Summary of Safety and Effectiveness Howmedica Osteonics® Modular Rotating Hinge Knee with Offset Adapters

| Proprietary Name: | Howmedica Osteonics® Modular Rotating<br>Hinge Knee with Offset Adapters | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Common Name: | Modular Rotating Hinge Knee | |
| Classification Name and Reference | Knee joint femorotibial metal/polymer<br>constrained cemented prosthesis, 21 CFR<br>§888.3510 | |
| Device Product Code: | 87 KRO | |
| For Information contact: | Francisco Haro, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] | |
| Date Summary Prepared: | February 9, 2006 | |

#### Description:

This Special 510(k) submission is a line extension intended to add offset adapters to the Howmedica Osteonics® Modular Rotating Hinge Knee.

#### Intended Use:

The combination of the predicate systems as cleared in the Howmedica Osteonics® Modular Rotating Hinge Knee and Howmedica Total Stabilizer Knee Components 510(k) premarket notifications does not alter the intended use. The subject and predicate devices are single use, sterile knee replacement systems. The indications for use for the Howmedica Osteonics® Modular Rotating Hinge Knee with Offset Adapters are provided below.

#### Indications for Use:

The Modular Rotating Hinge Knee is intended to be implanted with bone cement for the following conditions:

- . There is destruction of the joint surfaces, with or without significant bone deformity.
- The cruciate and/or collateral ligaments do not stabilize the knee joint. .

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- The ligaments are inadequate and/or the musculature is weak. .
- Revision is required of a failed prosthesis where there has been gross instability, with . or without bone loss or inadequate soft tissue.

## Substantial Equivalence:

The subject Howmedica Osteonics® Modular Rotating Hinge Knee with Offset Adapters share the same design, intended use, performance, materials, and operational principle as that of the currently available Howmedica Osteonics® Modular Rotating Hinge Knee and Howmedica Total Stabilizer Knee Components. An engineering analysis demonstrated comparable mechanical properties to the predicate components and substantial equivalence to these devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2006

Howmedica Osteonics Corp. C/o Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K060360

. K000500
Trade/Device Name: Howmedica Osteonics Modular Rotating Hinge Knee with Offset Adapters Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: February 9, 2006 Received: February 13, 2006

Dear Mr. Haro:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your because is receipe is substantially equivalent (for the indications referenced above and haves sure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreated to togens actment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food. Drug. de vices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, manner of the Act include requirements for annual registration, listing of general voltable proficturing 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 If your device is exassinou (sonal controls. Existing major regulations affecting your device can may oc subject to back additions, 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 r that FDA has made a determination that your device complies with other requirements of the Act that + Dr mas Intacted and regulations administered by other Federal agencies. You must or any I catal 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

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#### Page 2 - Mr. Francisco Haro

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. 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/industry/support/index.html.

Sincerely yours,

Hubert Lemmens

/ 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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# 0360

510(k) Number (if known):

Device Name: Howmedica Osteonics® Modular Rotating Hinge Knee with Offset Adapters

Indications for Use:

The Modular Rotating Hinge Knee is intended to be implanted with bone cement for the following conditions:

- There is destruction of the joint surfaces, with or without significant bone . deformity.
- The cruciate and/or collateral ligaments do not stabilize the knee joint. .
- The ligaments are inadequate and/or the musculature is weak. .
- The ngailents are many a failed prosthesis where there has been gross instability, . with or without bone loss or inadequate soft tissue.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|--------|
| | AND/OR |
| Over-The-Counter Use<br>(21 CFR 807 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Concurrence of CDR

Hulut
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number___ K060360 34