NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE

K013385 · Zimmer, Inc. · KRO · Jan 9, 2002 · Orthopedic

Device Facts

• Record ID: K013385
• Device Name: NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
• Applicant: Zimmer, Inc.
• Product Code: KRO · Orthopedic
• Decision Date: Jan 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3510
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is indicated for moderate to severe knee instability, significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, valgus, varus, or flexion deformities and/or for the salvage of previously failed surgical attempts. This device is intended for cemented use only.

Device Story

NexGen Rotating Hinge Knee (RHK) is a constrained total knee prosthesis; provides stability in anterior/posterior and medial/lateral directions while allowing flexion/extension and rotation. Operates via femoral hinge post extension inserted through polyethylene articular surface into tibial baseplate. Used in orthopedic surgery for joint reconstruction; implanted by surgeons. Components include femoral/tibial augments, stem extensions, and variable thickness articular surfaces for soft tissue tensioning. Output is a restored knee joint mechanism; aids in joint stability and function for patients with severe bone/ligament loss.

Clinical Evidence

No clinical data. Bench testing only: included interlock distraction (lift-off) testing, 10 million cycle tibial baseplate fatigue strength testing, and combined load fatigue/pin loosening testing. Contact area comparison performed against predicate. Wear testing not required due to polyethylene thickness > 6 mm.

Technological Characteristics

Constrained metal/polymer knee prosthesis. Materials include metal and polyethylene. Design features femoral hinge post extension and tibial baseplate. Cemented fixation only. Mechanical principle: constrained hinge mechanism allowing rotation and flexion/extension. No software or electronic components.

Indications for Use

Indicated for patients with moderate to severe knee instability, significant bone loss, or ligament deficiencies due to neoplasms, trauma, arthritis (rheumatoid, osteoarthritis, traumatic, polyarthritis), collagen disorders, avascular necrosis, or deformities (valgus, varus, flexion). Also for salvage of failed prior surgeries. 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

• Finn Knee System (K945028)

Submission Summary (Full Text)

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| JAN 0 9 2002 | Summary of Safety and Effectiveness |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
| Contact Person: | Stephen McKelvey<br>Manager, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | October 11, 2001 |
| Trade Name: | <i>NexGen</i> ® Complete Knee Solution Rotating Hinge<br>Knee |
| Common Name: | Total Knee Prosthesis |
| Classification Name<br>and Reference: | Knee joint femorotibial metal/polymer constrained<br>cemented prosthesis, 21 CFR § 888.3510 |
| Predicate Device: | Finn Knee System, manufactured by Biomet,<br>K945028, cleared February 14, 1996 |
| Device Description: | The <i>NexGen</i> Rotating Hinge Knee (RHK) is a knee<br>prosthesis that is constrained in the anterior/<br>posterior and medial/lateral directions but allows<br>flexion/extension and rotation between the femoral<br>and tibial components. Constraint in the anterior/<br>posterior and medial/lateral directions is<br>accomplished by means of a femoral hinge post<br>extension inserted through the polyethylene<br>articular surface into the tibial baseplate.<br><br>This prosthesis is designed to be used with Zimmer<br><i>NexGen</i> ® Complete Knee Solution patellar<br>components, femoral and tibial augments, and stem<br>extensions. The articular surface is available in<br>multiple thicknesses to facilitate soft tissue<br>tensioning and joint line restoration. Tibial<br>baseplate components are available in multiple sizes<br>to allow for optimal bone coverage and surgical<br>options. |

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This device is indicated for moderate to severe knee Intended Use: instability, significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, valgus, varus, or flexion deformities and/or for the salvage of previously failed surgical attempts. This device is intended for cemented use only. The RHK device is substantially equivalent to the Comparison to Predicate Device: Finn Knee System in that both have similar indications, design (both are constrained, rotating hinge knee prostheses), materials and mechanical safety. Both devices are intended for cemented use only. Non-Clinical Performance and Conclusions: Performance Data (Nonclinical and/or Clinical): Constraint testing is not applicable to a constrained prosthesis. This test was not necessary. Contact area was greater for the RHK than the Finn for the range 0 - 120°. At 130°, the Finn had greater contact area. The RHK interlock mechanism passed all distraction (lift-off) testing. All RHK test samples completed the 10 million cycle Tibial Baseplate Fatigue Strength testing without evidence of fracture or cracking. No additional lateral stability of the patellofemoral joint data was needed because the RHK uses similar patella femoral tracking as previously cleared NexGen femoral components. No additional shear strength or metal-backed patella static tensile data was needed because the RHK uses previously cleared patella devices. The RHK components passed all combined load fatigue and pin loosening testing.

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Minimum polyethylene thickness is greater than 6 mm, therefore, wear testing was not needed for the RHK device.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 9 2002

Mr. Stephen McKelvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K013385

Trade/Device Name: NexGen Complete Knee Solution Rotating Hinge Knee Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: October 11, 2001 Received: October 12, 2001

Dear Mr. McKelvey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 - Mr. Stephen McKelvey

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

દિવ

Sincerely yours,

Signature

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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## Indications for Use

KOS382

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510(k) Number (if known):

Device Name:

NexGen® Complete Knee Solution Rotating Hinge Knee

Indications for Use:

This device is indicated for moderate to severe knee instability, significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, valgus, varus, or flexion deformities and/or for the salvage of previously failed surgical attempts

This device is intended for cemented use only.

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

510(k) Number K ©1338 S

(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)