(88 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical, describing a bone anchor and suture system. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The "Not Found" entries for AI/ML mentions, image processing, training/test sets, and key metrics further support this conclusion.
No.
A therapeutic device is one that treats or manages a disease or condition. This device is a mechanical anchor for soft tissue to bone fixation, which is a structural repair rather than a therapeutic treatment.
No
Explanation: The device description and intended use clearly state that it is for the fixation of soft tissue to bone, making it a surgical implant rather than a diagnostic tool.
No
The device description clearly states it is a bone anchor with pre-attached sutures and a delivery handle, which are physical components, not software.
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 description details a physical implant (bone anchor) with sutures and a delivery handle, used in open or arthroscopic procedures. This is a surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is used to physically repair structures within the body.
N/A
Intended Use / Indications for Use
The KFx Peek Bone Anchor with Pre-Attached Sutures and Delivery Handle is 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 PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle is intended for the fixation of soft tissue to bone using Teleflex ForceFiber TM #2 nonabsorbable braided suture. The KFx PEEK Bone Anchor with Pre-Attached Sutures consists of a fixation device pre-loaded with suture in a delivery (insertion) handle. The PEEK bone anchor can be used in open or arthroscopic procedures.
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)
Non-clinical test data has established that the devices satisfies functional performance requirements and is safe and effective when used as indicated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
the existing KFx Knotless Fixation System, the Arthrex Corkscrew FT Suture Anchor, and the Opus Magnum Anchor with Inserter
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 OF SAFETY AND EFFECTIVENESS
6 2009 MAR
SUBMITTER 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 |
| Quality Assurance & Regulatory Affairs Director |
DEVICE IDENTIFICATION
| A. | Trade Name: | KFx PEEK Bone Anchor with Pre-Attached Suture
and Delivery Handle |
|----|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. | Catalog Number: | KFX-W-400F2 (4mm with 2 white sutures)
KFX-B-400F2 (4mm with 2 blue sutures)
KFX-WB-400F4 (4mm with 2 blue/2 white sutures)
KFX-W-500F2 (5mm with 2 white sutures)
KFX-B-500F2 (5mm with 2 blue sutures)
KFX-WB-500F4 (5mm with 2 blue/2 white sutures)
KFX-W-600F2 (6mm with 2 white sutures)
KFX-B-600F2 (6mm with 2 blue sutures)
KFX-WB-600F4 (6mm with 2 blue/2 white sutures) |
| C. | Common Name: | Bone Anchor |
| D. | Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| E. | Product Code: | MBI |
| F. | Device Class: | Class II (per 21 CFR 888.3040) |
IDENTIFICATION OF PREDICATE DEVICES
The KFx PEEK Bone Anchor with Pre-attached Sutures and Delivery Handle is substantially equivalent to the existing KFx Knotless Fixation System, the Arthrex Corkscrew FT Suture Anchor, and the Opus Magnum Anchor with Inserter cleared by the Food and Drug Administration.
1
DEVICE DESCRIPTION
The KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle is intended for the fixation of soft tissue to bone using Teleflex ForceFiber™ #2 nonabsorbable braided suture. The KFx PEEK Bone Anchor with Pre-Attached Sutures consists of a fixation device pre-loaded with suture in a delivery (insertion) handle. The PEEK bone anchor can be used in open or arthroscopic procedures.
INTENDED USE
The intended use of the KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle is for the fixation of soft tissue to bone in the shoulder, foot, ankle, knee, hand, wrist, and elbow. Please see indications for use statement for details.
TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE
The KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle is similar in materials, design, and operation to the predicate devices. Non-clinical test data has established that the devices satisfies functional performance requirements and is safe and effective when used as indicated.
BIOCOMPATIBILITY
The KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle is composed of materials that are currently utilized in a myriad of legally marketed orthopedic devices.
CONCLUSIONS DRAWN FROM STUDIES
The documentation provided in the 510(k) demonstrates that the KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle is substantially equivalent to the predicate devices and is safe and effective when used as indicated.
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 wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the emblem.
6 2009 MAR
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KFx Medical, Corporation % Mr. Gayle Hirota QA/RA Director 5845 Avenida Encinas, Suite 128 Carlsbad, California 92008
Re: K083609
Trade/Device Name: KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle
Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: December 5, 2008 Received: December 8, 2008
Dear Mr. 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.
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
3
Page 2 - Mr. Gayle Hirota
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) I ms letter will are your your finding of substantial equivalence of your device to a legally premated neticated 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, presencentialities 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 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,
Mark A. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 3.2 Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle
The KFx Peek Bone Anchor with Pre-Attached Sutures and Delivery Handle is intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow.
Specifically:
KO83609
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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
currence of CDRH, Office of Device Evaluation (ODE)
Concurrence of
Division of General, Restorative, and Neurological Devices
510(k) Number 4083604
Page 1 of 1
CONFIDENTIAL 34