HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE

K994207 · Howmedica Osteonics Corp. · KRO · Mar 13, 2000 · Orthopedic

Device Facts

• Record ID: K994207
• Device Name: HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
• Applicant: Howmedica Osteonics Corp.
• Product Code: KRO · Orthopedic
• Decision Date: Mar 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3510
• Device Class: Class 2
• Attributes: Therapeutic

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. Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

Device Story

Tricompartmental knee system; consists of stemmed femoral component, stemmed tibial rotating component, bushings, axle, and bumper. Provides motion via axle/bushing in flexion/extension plane; articulation between tibial rotating component and tibial insert provides rotation. Implanted with bone cement. Used by orthopedic surgeons in clinical/OR settings to restore joint function in patients with severe instability or bone loss. Benefits include stabilization of knee joint where ligaments are inadequate.

Clinical Evidence

Bench testing only; mechanical and multi-axis static testing performed to demonstrate comparable contact and constraint properties to predicate devices.

Technological Characteristics

Materials: Cast cobalt-chromium-molybdenum alloy (Vitallium, ASTM F-75) and UHMWPE (ASTM F648). Design: Tricompartmental, stemmed femoral/tibial components, rotating hinge mechanism. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring total knee arthroplasty due to joint surface destruction, ligamentous instability (cruciate/collateral), inadequate ligaments, weak musculature, or revision of failed prosthesis with gross instability/bone loss.

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 Kinematic Rotating Hinge Total Knee PR (K811630)
• Howmedica Duracon Total Stabilizer Knee (K932070)
• Howmedica Kinemax Plus Total Knee System (K910500)

Submission Summary (Full Text)

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MAR 1 3 2000

K994207

## 510(k) - Premarket Notification Summary of Safety and Effectiveness for the Howmedica Osteonics® Modular Rotating Hinge Knee

#### Submission Information

| Name and Address of the Sponsor | |
|------------------------------------|---------------------------------------|
| of the 510(k) Submission: | Howmedica Osteonics Corp. |
| | 59 Route 17 |
| | Allendale, NJ 07401-1677 |
| | |
| Contact Person: | Mary-Catherine Dillon |
| | Regulatory Affairs Team Member |
| | |
| Date of Summary Preparation: | December 10, 1999 |
| Device Identification | |
| Proprietary Name: | Howmedica Osteonics® Modular Rotating |
| | Hinge Knee |
| | |
| Common Name: | Modular Rotating Hinge Knee |
| | |
| Classification Name and Reference: | Prosthesis, Knee, Femorotibial, Semi- |
| | constrained |
| | |

#### Predicate Device Identification

The features of the Howmedica Osteonics® Modular Rotating Hinge Knee are substantially equivalent to features of the following Howmedica Osteonics predicate devices, which have been cleared for marketing via the 510(k) process (K811630, K932070, and K910500 respectively):

- · Howmedica Kinematic Rotating Hinge Total Knee PR.
- Howmedica Duracon Total Stabilizer Knee
- Howmedica Kinemax Plus Total Knee System

#### Device Description

The Modular Rotating Hinge Knee is a tricompartmental knee system. It consists of a stemmed femoral component and a stemmed tibial rotating component connected by a set of bushings and an axle. A bumper locks this assembly. This assembly provides motion through the axle/bushing combination in the flexion/extension plane. The articulation between the cylindrical bearing surfaces

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on the underside of the tibial rotating component and a tibial insert provide motion in the rotation plane. The tibial insert is assembled to a tibial stemmed tray which incorporates a longitudinal bore to accept a tibial sleeve. The metallic components are manufactured from cast cobalt-chromiummolybdenum alloy (Vitallium® Alloy) conforming to ASTM F-75. The polyethylene components are manufactured from Ultra-High Molecular-Weight Polyethylene (UHMWPE) conforming to standard ASTM F648.

#### 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.

#### Statement of Technological Comparison:

The components of the Modular Rotating Hinge Knee share material, intended uses, and basic design concepts as those of the predicate devices, the Kinematic Rotating Hinge Knee, Kinemax Plus, and the Duracon Total Stabilizer Knee. Mechanical and multi-axis static testing demonstrate the comparable contact and constraint properties of these components.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2000

Ms. Mary-Catherine Dillon Regulatory Affairs Team Member Howmedica Osteonics Corporation 59 Route 17 Allendale. New Jersey 07401-1677

Re: K994207

Trade Name: Howmedica Osteonics® Modular Rotating Hinge Knee Regulatory Class: II Product Code: KRO Dated: December 10, 1999 Received: December 14, 1999

Dear Ms. Dillon:

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 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 control provisions of the Act. The general control 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 requirement, 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.

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.

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#### Page 2 - Ms. Mary-Catherine Dillon

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" (21 CFR 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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Rundt Paya

So James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known): K_994207

#### Device Name: Howmedica Osteonics® Modular Rotating Hinge Knee

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.

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X Over-The-Counter Use OR

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Donnell Ray

Division Sign-Off) Division of Circeral Restorative Devices 994209 510(k) Number