(79 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical, describing a physical anchor for tissue fixation. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is described as a fixation device (suture and tissue anchors) used to attach soft tissue to bone, which is a surgical tool rather than a therapeutic device that directly treats or prevents disease.
No
The device description indicates it is a fixation device for soft tissue to bone, used in surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is comprised of physical components (body, legs, wedge, suture loop, delivery handle) and is intended for surgical implantation, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (suture anchors and tissue anchors) used to physically fix soft tissue to bone during surgical procedures. It does not involve testing samples from the body.
The device is a surgical implant used for mechanical fixation within the body, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The KFx APPIANFx™ PEEK Suture Anchors and APPIANFx™ PEEK Tissue Anchors 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, 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 APPIANFx™ PEEK Suture Anchors consist of a fixation device comprised of a body with deployable legs, a wedge, and a disposable suture loop preloaded in a delivery (insertion) handle. The KFx APPIANFx™ PEEK Tissue Anchors consist of a fixation device comprised of a body with deployable legs and a cleated wedge preloaded in a delivery (insertion) handle. Each device is intended for single use and may be used in arthroscopic and open procedures. Devices are provided "STERILE": sterilization is by radiation (E-Beam) and provides a sterility assurance level of 10-6.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test data (deployment, static pull-out, and cyclic sufure retention testing) indicate that the device is safe and satisfies functional performance requirements when used as indicated and do not raise new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle.
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
Special 510(k) Premarket Notification KFx APPIANFx™ PEEK Suture Anchors and KFx APPIANFx™ PEEK Tissue Anchors
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
JUN - 7 2012
APPLICANT INFORMATION
| A. | Company Name: | KFx Medical, Corporation |
|---|---|---|
| B. | Company Address: | 5845 Avenida Encinas |
| Suite 128 | ||
| Carlsbad, CA 92008 | ||
| C. | Company Phone: | (760) 444-8844 |
| D. | Company Facsimile: | (760) 602-9252 |
| E. | Contact Person: | Gayle Hirota |
| Director QA/RA | ||
| DEVICE IDENTIFICATION | ||
| A. | Trade Name: | KFx APPIANFx™ PEEK Suture Anchors and KFx |
| APPIANFx™ PEEK Tissue Anchors | ||
| B. | Catalog Number: | KFX-MST-150 (5.0mm Suture Anchor) |
| KFX-MST-160 (6.0mm Suture Anchor) | ||
| KFX-GTO-160 (6.0mm Tissue Anchor) | ||
| C. | Common Name: | Bone Anchor |
| D. | Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| E. | Product Code: | MBI |
| F. | Device Panel: | Orthopedic |
| G. | Device Class: | Class II |
IDENTIFICATION OF MODIFIED DEVICE
The KFx APPIANFx™ PEEK Suture Anchors and KFx APPIANFx™ PEEK Tissue Anchors are substantially equivalent to the KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle.
.: バ
DEVICE DESCRIPTION
The KFx APPIANFx™ PEEK Suture Anchors consist of a fixation device comprised of a body with deployable legs, a wedge, and a disposable suture loop preloaded in a delivery (insertion) handle. The KFx APPIANFx™ PEEK Tissue Anchors consist of a fixation device comprised of a body with deployable legs and a cleated wedge preloaded in a
1
delivery (insertion) handle. Each device is intended for single use and may be used in arthroscopic and open procedures.
Devices are provided "STERILE": sterilization is by radiation (E-Beam) and provides a sterility assurance level of 10-6.
INTENDED USE
The intended use of the KFx APPIANFx™ PEEK Suture Anchors and KFx APPIANFx™ PEEK Tissue Anchors are for the fixation of soft tissue to bone in the shoulder, foot, ankle, knee, hand, wrist, and elbow.
BIOCOMPATIBILITY AND PERFORMANCE DATA
The materials used in the KFx APPIANFx™ PEEK Suture Anchors and KFx APPIANFx™ PEEK Tissue Anchors are biocompatible. The same materials are used in a myriad of legally marketed orthopedic devices.
Non-clinical test data (deployment, static pull-out, and cyclic sufure retention testing) indicate that the device is safe and satisfies functional performance requirements when used as indicated and do not raise new issues of safety or effectiveness.
CONCLUSIONS DRAWN FROM STUDIES
The documentation provided demonstrates that the KFx APPIANFx™ PEEK Suture Anchors and KFx APPIANFx™ PEEK Tissue Anchors are substantially equivalent to the currently marketed predicate device and is safe and effective when used as indicated.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 7 2012
KFx Medical. Corporation % Ms. Gayle Hirota Director, Quality Assurance / Regulatory Affairs 5845 Avenida Encinas, Suite 128 Carlsbad, California 92008
Re: K120841
Trade/Device Name: KFx AppianFx PEEK Suture Anchors and KFx AppianFx PEEK Tissue Anchors
Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: May 8, 2012
Received: May 9, 2012
Dear Ms. Hirota:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Ms. Gayle Hirota
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours
() €
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| SECTION 1.6 | Indications for Use |
|---|---|
| 510(k) Number (if known): K120841 | |
| Device Name: | KFx APPIANFx™ PEEK Suture Anchors and APPIANFx™ PEEK |
| Tissue Anchors | |
| Indications For Use: The KFx APPIANFx™ PEEK Suture Anchors and APPIANFx™ | |
| PEEK Tissue Anchors 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, 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, |
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
biceps tendon reattachment.
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ant
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
ખ્યત્વે જેવા ત્યારે તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના 510(k) Number .
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CONFIDENTIAL