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 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.
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.

AI/ML Overview

This document (K061765) is a 510(k) premarket notification for a medical device called the KALIX® II Flat Foot implant. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, and does not pose new questions of safety or effectiveness.

Therefore, this document does not describe acceptance criteria for device performance in the way you might find in a clinical trial or performance study, nor does it present a study that proves the device meets such criteria. Instead, the "acceptance criteria" here are regulatory criteria for substantial equivalence to a predicate device. The "study" is the submission itself, which primarily focuses on demonstrating similarities to a previously cleared device.

Specifically, the device is being cleared based on its substantial equivalence to the KALIX® II Flat Foot implant, K053093. The modifications to the new device are minor (anodization of the device) and are stated not to change the intended use or fundamental scientific technology.

Given this context, I cannot populate all the fields in your request directly as they pertain to a performance study with defined acceptance criteria and detailed study methodology. However, I can interpret the document's information in relation to a "regulatory acceptance" framework for substantial equivalence.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Regulatory)	Reported Device Performance (Demonstrated Equivalence)
Intended Use: Device has the same intended use as the predicate device.	Same Intended Use: "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." (Page 1)
Materials: Device uses same or equivalent materials as the predicate device.	Same Materials: "The KALIX® II Flat Foot implant is a combination of three components. Two of them are made from Titanium alloy (Ti-6Al-4V)... The outer sleeve is made from Ultra High Molecular Weight Polyethylene (UHMWPE)... These are the same materials as the unmodified device, KALIX® II Flat Foot implant, K053093." (Page 2)
Basic Design: Device has the same basic design as the predicate device.	Same Basic Design: Explicitly stated under "Comparison of Technological Characteristics" (Page 2).
Instructions for Use: Device has the same Instructions for Use as the predicate device.	Same Instructions for Use: Explicitly stated under "Comparison of Technological Characteristics" (Page 2).
Manufacturing Process: Device uses same or equivalent manufacturing process as the predicate device, with any changes not affecting safety/effectiveness.	Same Manufacturing Process: "Same manufacturing process (but anodization of the new device)" (Page 2). The submission implies this change does not raise new issues of safety or effectiveness.
Sterilization & Packaging: Device is delivered sterile using the same materials and processes as the predicate device.	Same Sterilization & Packaging: "Are delivered sterile packaged using the same materials and processes" (Page 2).
Does not raise new safety or effectiveness concerns.	No New Concerns: "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." (Page 2) This is the overarching conclusion drawn from the comparison of characteristics.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This is a 510(k) submission based on substantial equivalence to a predicate device, not a performance study on live subjects or retrospective data with a "test set" in the typical sense. The "test" is the comparison of characteristics against the predicate device.
Data Provenance: Not applicable. The data provenience is the comparison of the characteristics of the proposed device against the predicate device (K053093) as reported by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There was no "test set" with a ground truth requiring expert consensus for this submission. The "ground truth" for the predicate device's safety and effectiveness was established during its own 510(k) clearance (K053093). For this submission, the "ground truth" is primarily based on the documented specifications and characteristics of both the new and predicate devices.

4. Adjudication method for the test set

Not applicable. No "test set" requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a surgical implant, not a diagnostic imaging device with human readers or AI components.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a surgical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for demonstrating substantial equivalence is the predicate device (K053093) and its previously established safety and effectiveness. The comparison relies on documented device specifications, materials standards (ISO, ASTM), and the manufacturer's assessment that changes are minor.

8. The sample size for the training set

Not applicable. There is no "training set" for this type of submission.

9. How the ground truth for the training set was established

Not applicable. No "training set." The "ground truth" for the predicate device and its characteristics as a basis for comparison was established through its prior 510(k) clearance process.

Summary

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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.: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52 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: 609-936-2311 Fax: 609-275-9445

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

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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

Page 1 of 1

510(k) Number K061765

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.