(34 days)
No
The summary describes a physical implant for foot treatment and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an implant used for the treatment of a hyperpronated foot and stabilization of the subtalar joint, directly addressing a medical condition.
No
The device description clearly states its purpose: "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..." This indicates it is a therapeutic implant for treatment, not a device used to diagnose a condition.
No
The device description explicitly states it is an "implant," which is a physical medical device intended to be surgically placed in the body. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The KALIX II implant is a physical implant designed to be surgically placed in the foot to treat a specific anatomical condition (hyperpronated foot and subtalar joint instability). It directly interacts with the body's structure.
- Intended Use: The intended use is for surgical treatment and stabilization of a physical condition, not for analyzing biological samples.
The information provided clearly describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / 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. -
Product codes
HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, subtalar joint, talus
Indicated Patient Age Range
children and adolescents
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
KOJ3093 p½
Image /page/0/Picture/1 description: The image shows the logo for Newdeal, which is "An Integra LifeSciences Company". The logo includes a circle with five dots around it. The text "DEC 7" is also visible in the upper right corner of the image.
510(k) SUMMARY
2005
- 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: 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.
1
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.
2
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.
3
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 (800) 638-2041 or (301) 443-6597 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
4
Indications for Use
510(k) Number (if known):
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_