AEQUOS

K033260 · Aap Implantate AG · JWH · Dec 7, 2004 · Orthopedic

Device Facts

• Record ID: K033260
• Device Name: AEQUOS
• Applicant: Aap Implantate AG
• Product Code: JWH · Orthopedic
• Decision Date: Dec 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ÆQUOS- Knee- Endoprosthesis is intended to provide mobility and reduce pain by replacing the damaged knee joint articulation. Candidates for total knee joint includes patients with a severely painful and/or severly disabled joint resulting from different syndromes. The indications are: - . Damaged and seriously damaged and painful knee joints with relevant malfunction, instability or subluxation of the joint - Therapy resistant bow contracture of more than 20° or non compensable . malposition of the anatomical axis from approximatly 15-20° - Double sided joint anchylosis or anchylosis of the opposite hip joint ● - All conservative therapies were unsuccessful or joint conserving operations . provide no success or have already failed - Failure after implantation of monocondylar implants . - Stiffening of the joint is contraindicated .

Device Story

Total knee endoprosthesis system; replaces damaged knee joint articulation to restore mobility and reduce pain. Components include anatomic/asymmetrical femoral components (cast CoCr alloy), tibial baseplate (cast CoCr alloy), and tibial inserts/spacers (UHMWPE). Intended for cemented use only. Implanted by orthopedic surgeons in clinical/hospital settings. Device provides mechanical structural replacement of the knee joint; clinical benefit derived from restoring joint function and alleviating pain in patients where conservative treatments have failed.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Cobalt Chromium Alloy (ASTM F75) and Ultra-High Molecular Weight PolyEthylene (ISO 5834-2). Design: Semi-constrained, cemented, patellofemorotibial prosthesis. Components: Femoral, tibial baseplate, tibial inserts, and spacers. Sterilization: Gamma radiation (min 2.5 Mrad) for sterile components; end-user steam sterilization for non-sterile components per AAMI/ISO 11737.

Indications for Use

Indicated for patients with severely painful/disabled knee joints due to damage, malfunction, instability, subluxation, therapy-resistant bow contracture (>20°), malposition of anatomical axis (15-20°), or joint anchylosis. Applicable when conservative/joint-conserving therapies fail or after monocondylar implant failure. Contraindicated for patients in poor general/skin condition, untreated metabolic malfunction, joint destruction from hemophilia/tabes/infection, or joint ligament instability.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Anatomic Total Knee (k000978)
• Columbus (CR) Total Knee System (k023788)
• Nexgen Complete Knee Solution Trabecular Metal (k024161)
• Maxim Accel Knee System (k023546)

Submission Summary (Full Text)

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K033260

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000 Implantate /

*MEBIC

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Submitters Name: | aap Implantate AG |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| | Lorenzweg 5 |
| | 12099 Berlin |
| DEC - 7 2004 | Germany |
| | Phone: [phone] |
| | Fax: [phone] |
| Contact Name: | Marc Seegers, Director Quality Management<br>email: [e-mail] |
| Name of Device: | ÆQUOS Knee Endoprosthesis cemented |
| Classification Name: | Knee joint patellofemorotibial<br>polymer/metal/polymer<br>semi-constrained cemented prosthesis |
| Common/Usual Name: | Knee-Endoprosthesis |
| Proprietary Name: | ÆQUOS-Knee- Endoprosthesis |
| Device Class: | Class II |
| Product Code: | 87 J WH |
| Classification: | CFR Chapter I, Title 21 § 888.3560 Knee joint<br>patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis |
| Review Panel: | Orthopaedics |

Performance Standards:

Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable harmonised standards ISO 9001 / EN 46001.

## Material Composition:

ÆQUOS- Knee- Endoprosthesis components are manufactured of Cobalt Chromium Alloy (ASTM F75) and Ultra-High Molecular Weight PolyEthylene (ISO 5834-2)

#### Intended Use:

ÆQUOS- Knee- Endoprosthesis is intended to provide mobility and reduce pain by replacing the damaged knee joint articulation. Candidates for total knee joint includes patients with a severely painful and/or severly disabled joint resulting from different syndromes.

The indications are:

- . Damaged and seriously damaged and painful knee joints with relevant malfunction, instability or subluxation of the joint
- Therapy resistant bow contracture of more than 20° or non compensable . malposition of the anatomical axis from approximatly 15-20°
- Double sided joint anchylosis or anchylosis of the opposite hip joint ●

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- All conservative therapies were unsuccessful or joint conserving operations . provide no success or have already failed
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- Failure after implantation of monocondylar implants .
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- Stiffening of the joint is contraindicated .
The contra-indications are:

- Badly condition of the patient .
- . Badly condition of the skin
- Untreated malfunction of the metabolism .
- Joint destruction caused by haemophilia, tabes or after infections .
- Instability of the joint ligaments .

The ÆQUOS knee endoprosthesis is only for use with bone cement

## Device Description:

The ÆQUOS knee endoprosthesis consists of:

- Femoral components in anatomic and asymmetrical design a) manufactured from cast CoCr alloy (ASTM F75). Femoral components are intended for cemented use only.
- b) Tibial baseplate in anatomic design manufactured from cast CoCr alloy (ASTM F75). The tibial baseplate is a non-porous, stemmed configuration and intended for cemented use only.
- c) Tibial inserts in anatomic and asymmetrical design manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE)
- d) Tibial spacers

## Predicate Devices for Substantial Equivalence:

ÆQUOS is similar in size, material and intended use to the

- Anatomic Total Knee (k000978) of Biomet, Inc. .
- Columbus (CR) Total Knee System (k023788) of Aesculap, Inc. .
- Nexgen Complete Knee Solution Trabecular Metal (k024161) of Implex . Corp.
- Maxim Accel Knee System (k023546) of Biomet, Inc. .

Comparision of Technological Characteristics: Æquos is substantially equivalent to the predicate devices with respect to physical/technical and material characteristics.

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#### Sterilisation Information:

The ÆQUOS Knee- Endoprosthesis are distributed in sterile condition.

The instruments and implants provided in non-sterile condition must be decontaminated, cleaned and sterilised prior to each surgery. All packaging materials must be removed.

Recommendations for sterilisation are contained in the package insert.

Note: These devices are sterilised by end users utilizing the approved/outlined quidelines found in the AAMI Guideline "Good Hospital Practice: Steam Sterilisation and Sterility Assurance" and in ANSI/AAMI/ISO 11737 guidelines to achieve the acceptable Sterility Assurance Level (SAL).

Devices which are available in sterile condition are sterilised with gamma radiation sterilisation. A radiation dose of at least 2.5 Mrad is utilized. The sterility assurance level (SAL) is 10°. The validation has been carried out according to the standard ISO 11137.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 7 2004

Mr. Marc Seegers Director Quality Management aap Implantate AG Lorenzweg 5 12099 Berlin Germany

Re: K033260 Trade/Device Name: ÆQUOS Knee Endoprosthesis Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: November 26, 2004 Received: November 29, 2004

Dear Mr. Seegers:

We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve a nowe 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 for use batter in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner or provise they to they accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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. Marc Seegers

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter notification. The FDA finding of substantial equivalence of your device to a legally premailed 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 11 you a 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/dsma/dsmamain.html

Sincerely yours,

Mark A. Milburn

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 Statement

Page 1 of 1

510(k) Number (if known): 长033260

Device Name: ÆQUOS Knee Endoprosthesis

## Indications for Use:

- Damaged and seriously damaged and painful knee joints with relevant malfunction, . instability or subluxation of the joint
- Therapy resistant bow contracture of more than 20° or non compensable malposition . of the anatomical axis from approximatly 15-20°
- Double sided joint anchylosis or anchylosis of the opposite hip joint .
- All conservative therapies were unsuccessful or joint conserving operations provide no . success or have already failed
- Failure after implantation of monocondylar implants .
- Stiffening of the joint is contraindicated .

Prescription Use v (Per 21 CFR 801.109) OR

Over-The-Counter Use

R. Mark A. Milkersen

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

510(k) Number K033260