KALIX II IMPLANT, MODEL 141 0XX WITH XX

K053093 · New Deal, S.A. · HWC · Dec 7, 2005 · Orthopedic

Device Facts

• Record ID: K053093
• Device Name: KALIX II IMPLANT, MODEL 141 0XX WITH XX
• Applicant: New Deal, S.A.
• Product Code: HWC · Orthopedic
• Decision Date: Dec 7, 2005
• 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.

Device Story

KALIX II is a metallic bone fixation fastener used for subtalar joint stabilization and treatment of hyperpronated foot. Implant blocks forward, downward, and medial displacement of talus to prevent excessive pronation while maintaining normal joint motion. Device is surgically implanted by a physician. It serves as a mechanical intervention for patients with flat foot deformities or instability who have not responded to conservative orthopaedic treatments.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Metallic bone fixation fastener. Design and materials are identical to the predicate KALIX implant (K001231). Delivered sterile.

Indications for Use

Indicated for treatment of hyperpronated foot and subtalar joint stabilization in children and adolescents. Specific conditions include congenital flat foot, failed long-term orthopaedic treatment, tarsal coalitions, painful flat foot, supple deformity in posterior tibial tendon dysfunction, paralytic flat foot, and subtalar instability.

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 implant (K001231)

Submission Summary (Full Text)

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KOJ3093 p½

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## 510(k) SUMMARY

2005

- 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: October 31, 2005
- 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 Implant, K001231.

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#### Indications for Use F.

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.

#### G. Substantial Equivalence

The new KALIX® II implant is substantially equivalent in function and intended to the commercially marketed device, KALIX ® implant, K001231.

#### H. Comparison of Technological Characteristics

The modified KALIX II implant has the following similarities to the unmodified device, KALIX implant, 510(k) K001231:

- Same intended use -
- Same materials -
- -Same basic design
- Same Instructions for Use -
- Same manufacturing -
- Delivered sterile packaged using the same packaging materials and processes

#### I. Conclusion

Valid scientific evidence through performance testing provide reasonable assurance that the KALIX® II implant is substantially equivalent to commercially marketed device, KALIX® implant, K001231. 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 features the department's name encircling a symbol. The symbol consists of four stylized human figures, representing the department's mission to protect the health of all Americans and provide essential human services.

2005 DEC 7

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Newdeal SAS c/o Judith O'Grady Sr. VP Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K053093

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 Codes: HWC Dated: October 31, 2005 Received: November 7, 2005

Dear Ms. O'Grady:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to tegans actment date of the Medical Device Amendments, or to conninered prior to May 20, 1977) in accordance with the provisions of the Federal Food, Drug, ucerices that have been require approval of a premarket approval application (PMA). and Cosmetic Ac+(110) the ) the device, subject to the general controls provisions of the Act. The I va may, merelore, manes of the Act include requirements for annual registration, listing of general controls provisions 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 to such additional controls. Existing major regulations affecting your device can may or subject to back adden accept 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 r house of acribed a determination that your device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must of any I odetar statuted and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic in form in the quality of oversions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2 - Judith O'Grady

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to ogin mains 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 If you desire specific advice 10. Jour 240) 276-0120. Also, please note the regulation entitled, Connect the Office of Comparket notification" (21CFR Part 807.97). You may obtain Misoranuing of Yeference to premainsmonsibilities under the Act from the Division of Small other general information on Journer 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,
Mark A. Mellersen

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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# Indications for Use

510(k) Number (if known):

K053093

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 ... ) -
- 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)

Mark A. Milken

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

510(k) Number_