KALIX II IMPLANT

K061765 · New Deal, S.A. · HWC · Jul 18, 2006 · Orthopedic

Device Facts

• Record ID: K061765
• Device Name: KALIX II IMPLANT
• Applicant: New Deal, S.A.
• Product Code: HWC · Orthopedic
• Decision Date: Jul 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The KALIX II implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. - flat foot treatment in children and adolescents - congenital flat foot - non successful long term orthopaedic treatment (shoes, insoles ... ) - tarsal coalitions - painfully flat foot - supple deformity in posterior tibial tendon dysfunction - paralytic flat foot - subtalar instability.

Device Story

KALIX II is a bone fixation implant for subtalar joint stabilization; treats hyperpronated foot by blocking forward, downward, and medial talar displacement. Implant consists of three components: two titanium alloy (Ti-6Al-4V) parts and one UHMWPE outer sleeve. Used by orthopedic surgeons in clinical settings to correct foot deformities and restore normal subtalar motion. Device is delivered sterile.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and intended use similarity to the predicate device.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V) per ISO 5832-3/ASTM F136; UHMWPE per ASTM F648-00. Form factor: Three-component bone fixation fastener. Sterilization: Sterile packaged. Manufacturing: Includes anodization.

Indications for Use

Indicated for children and adolescents with hyperpronated foot, congenital flat foot, tarsal coalitions, painful flat foot, supple deformity in posterior tibial tendon dysfunction, paralytic flat foot, or subtalar instability, following failed long-term orthopaedic treatment.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• KALIX II Implant (K053093)

Submission Summary (Full Text)

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K061765

Image /page/0/Picture/1 description: The image shows the logo for Newdeal, an Integra LifeSciences Company. The logo features the word "newdeal" in bold, black letters, with a circle to the left containing four smaller circles in black, white, and gray. Below the word "newdeal" is the text "An Integra LifeSciences Company" in a smaller, lighter font. The logo is simple and modern, with a focus on the company name.

JUL 1 8 2006

# 510(k) SUMMARY

A. Submitter's Name and Address: Newdeal SAS 10, place d'Helvétie 69006 LYON FRANCE Tel.: [phone] Fax: [phone] ESTABLISHMENT REGISTRATION NUMBER: 9615741

## B. Authorized Agent and Official Contact Person: Judith O'Grady Sr. VP Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA Tel: [phone] Fax: [phone]

- C. Date Summary Prepared: June 21, 2006
- D. Name of Device: Proprietary Name: KALIX® II

Common Name: Screw, Fixation, Bone

Classification Name and Reference: Smooth or threaded metallic bone fixation fastener (21CFR 888.3040)

Device Product Code: HWC

Proposed Regulatory Class: Class II

Panel: Orthopedic

#### E. Device Description

The KALIX® II Flat Foot implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. This is the same indication for use as the Kalix® II Implant, K053093.

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The KALIX® II Flat Foot implant is a combination of three components. Two of them are made from Titanium alloy (Ti-6Al-4V) that conforms to both ISO 5832-3 and ASTM F136 standards. The outer sleeve is made from Ultra High Molecular Weight Polyethylene (UHMWPE) is an conforms to ASTM F648-00 standard. These are the same materials as the unmodified device, KALIX® II Flat Foot implant, K053093.

### F. Indications for Use

The KALIX® II implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talughted to allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

- flat foot treatment in children and adolescents -
- congenital flat foot
- non successful long term orthopaedic treatment (shoes, insoles ... ) -
- tarsal coalitions
- painfully flat foot -
- supple deformity in posterior tibial tendon dysfunction -
- paralytic flat foot
- subtalar instability. -

#### G. Substantial Equivalence

The new KALIX® II implant is substantially equivalent to commercially marketed device, KALIX® II implant, K053093.

### H. Comparison of Technological Characteristics

The modified KALIX® II implant has the following similarities to the unmodified device, KALIX® II implant, 510(k) K053093:

- Same intended use -
- Same materials -
- . Same basic design
- Same Instructions for Use -
- Same manufacturing process (but anodization of the new ー device)
- Are delivered sterile packaged using the same materials and processes

#### I. Conclusion

The new KALIX® II implant is substantially equivalent to commercially marketed device, KALIX® II implant, K053093.

The modifications do not change the intended use or fundamental scientific technology of the device and do not raise any new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2006

Newdeal SAS % Integra LifeSciences Corporation Ms. Judith E. O'Grady Sr. Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K061765

Trade/Device Name: Kalix® II flat foot implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 16, 2006 Received: June 22, 2006

Dear Ms. O'Grady:

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

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Page 2 - Ms. Judith E. O'Grady .

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.

Sauvan buetum
for

Mark N. Melkerson 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

510(k) Number (if known): 06/765

Device Name: KALIX® II flat foot implant

Indications For Use:

The KALIX II implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

- flat foot treatment in children and adolescents
- congenital flat foot
- non successful long term orthopaedic treatment (shoes, insoles ... ) l
- tarsal coalitions -
- painfully flat foot -
- supple deformity in posterior tibial tendon dysfunction
- paralytic flat foot
- subtalar instability.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

-

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carbare Buchip

Division of General, Restorative, and Neurological Devices

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510(k) Number K061765