(91 days)
Not Found
No
The summary describes a mechanical tissue fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is intended for the fixation of soft tissue to bone, which is a structural or mechanical function, not a therapeutic one that directly treats a disease or condition.
No
The text describes a system for the surgical fixation of soft tissue to bone, which is a treatment or repair function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components, including bone anchors, handles, and optional accessories like graspers and removal devices. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device components are physical implants and surgical tools (bone anchors, handles, graspers, etc.) used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases, monitor conditions, or screen for health issues. This device is a surgical implant and tool used for mechanical fixation within the body.
N/A
Intended Use / Indications for Use
The KFx Tissue Fixation System and optional accessories are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow.
Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs.
Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis, patellar tendon repair.
Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.
Product codes
MBI
Device Description
The KFx Tissue Fixation System consists of
- KFx Nail Bone Anchor with two suture leads, mounted to a single use handle .
- . KFx Suture Lock Bone Anchor mounted to a single use handle
- . Optional KFx Targeting Grasper
- Optional Suture Management Device(s) .
- . Optional Screw Removal device
- Optional Starter Awl .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, knee, hand/wrist, and elbow.
Indicated Patient Age Range
Not Found
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)
Results of physical bench testing demonstrate that the KFx Tissue Fixation System meets its specifications and does not raise 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
510(k) Summary
UCT 26 2007
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: July 20, 2007
510(k) number: K072063
Applicant Information:
KFx Medical 5145 Avenida Encinas Suite C Carlsbad, CA 92008
Contact Person
| M. D. Heaven | |
|---|---|
| Phone number: | 619 270 8478 |
| FAX number: | 760 602 9252 |
| e-mail: | malcolm.heaven@kfxmed.com |
Device Information:
| Trade Name: | KFx Tissue Fixation System and Accessories |
|---|---|
| Classification: | Class II |
| Classification Name: | Screw, Fastener, Fixation, Non-degradable, Soft Tissue |
Physical Description:
The KFx Tissue Fixation System consists of
- KFx Nail Bone Anchor with two suture leads, mounted to a single use handle .
- . KFx Suture Lock Bone Anchor mounted to a single use handle
- . Optional KFx Targeting Grasper
- Optional Suture Management Device(s) .
- . Optional Screw Removal device
- Optional Starter Awl .
Intended Use:
The KFx Tissue Fixation System and optional accessories are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow.
Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs.
1
Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis, patellar tendon repair.
Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment..
Equivalent Device:
The KFx Tissue Fixation System is substantially equivalent to existing suturing devices cleared by the Food and Drug Administration. The KFx Medical Knotless Fixation System (K061294), the Arthrex Corkscrew FT II Suture Anchor (K050358), and the Arthrex FASTak II Suture Anchor (K971723) devices, are examples of substantially equivalent devices with the same intended use, design and technology characteristics requested by KFx Medical, Inc. The intended use of the KFx Tissue Fixation System is substantially equivalent to the intended use of the suturing devices listed above.
Test Results:
Performance
Results of physical bench testing demonstrate that the KFx Tissue Fixation System meets its specifications and does not raise new issues of safety or effectiveness.
Biocompatibility
The materials used in the KFx Tissue Fixation System are biocompatible. The same materials are used in the identified predicates and are also commonly used in similar medical devices.
Summary:
Based on the intended use, product, performance and biocompatibility information provided in this notification, the KFx Tissue Fixation System has been shown to be substantially equivalent to the currently marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2007
KFx Medical % Mr. Malcolm D. Heaven Vice President Research and Development 5145 Avenida Encinas, Suite C Carlsbad, California 92008
K072063 Trade Name: KFx Tissue Fixation System and Accessories Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: July 24, 2007 Received: July 31, 2007
Dear Mr. Heaven:
Re:
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 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.
3
Page 2 - Mr. Malcolm D. Heaven
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson 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): K072063
Device Name: KFx Tissue Fixation System and Accessories
Indications for Use:
The KFx Tissue Fixation System and optional accessories are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow.
Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs. rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs.
Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions. Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis, patellar tendon repair.
Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.
V Prescription Use (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
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KFx Medical
CONFIDENTIAL
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