(30 days)
Not Found
No
The device description and intended use focus on mechanical fixation of tissue to bone using anchors and sutures. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is described as a "Tissue Fixation System" intended for the "fixation of soft tissue to bone" to repair and reconstruct various injuries in different anatomical sites, which directly relates to treating medical conditions.
No
The device is described as a "Tissue Fixation System" intended for the "fixation of soft tissue to bone," which is a treatment or repair function, not a diagnostic one.
No
The device description clearly states it is comprised of physical components (Bone Screw Anchor and Nail Bone Anchor) and is provided "STERILE", indicating a physical medical device, not software.
Based on the provided text, 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 system of anchors and sutures used for physical fixation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on in vitro analysis.
This device is a surgical implant/instrument used for musculoskeletal repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the KFx 5.5mm Suture Lock Bone Screw Anchor is 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 repairs, lateral ligament repairs, posterior oblique ligament repairs, Iliotibial band tenodesis, patellar tendon repairs.
Hand, Wrist and Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The KFx Tissue Fixation System is intended for the fixation of soft tissue to bone using Teleflex ForceFiber® #2 braided suture. The KFx 5.5mm Suture Lock Bone Screw Anchor component of the Tissue Fixation System is used to capture the Nail Bone Anchor sutures, eliminating the need to tie suture knots.
The KFx Nail Bone Anchor and the KFx Suture Lock Bone Screw Anchors are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas.
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)
Bench test results 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K08029 page '42
Special 510(k) Premarket Notification KFx 5.5mm Suture Lock Bone Screw Anchor
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
APPLICANT INFORMATION
| A. | Company Name: | KFx Medical, Inc |
|---|---|---|
| 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 |
| QA/RA |
DEVICE IDENTIFICATION
| A. | Trade Name: | KFx 5.5mm Suture Lock Bone Screw Anchor |
|---|---|---|
| B. | Common Name: | Bone Anchor |
| C. | Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| D. | Product Code: | MBI |
| E. | Device Panel: | Orthopedic |
| F. | Device Class: | Class II |
IDENTIFICATION OF MODIFIED DEVICE
The KFx 5.5mm Suture Lock Bone Screw Anchor is similar in basic design and intended use to the KFx Medical Suture Lock Bone Anchor, cleared under 510(k) K072063.
DEVICE DESCRIPTION
The KFx Tissue Fixation System is intended for the fixation of soft tissue to bone using Teleflex ForceFiber® #2 braided suture. The KFx 5.5mm Suture Lock Bone Screw Anchor component of the Tissue Fixation System is used to capture the Nail Bone Anchor sutures, eliminating the need to tie suture knots.
The KFx Nail Bone Anchor and the KFx Suture Lock Bone Screw Anchors are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas.
CONFIDENTIAL
1
INTENDED USE
The intended use of the KFx 5.5mm Suture Lock Bone Screw Anchor is 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 repairs, lateral ligament repairs, posterior oblique ligament repairs, Iliotibial band tenodesis, patellar tendon repairs.
Hand, Wrist and Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.
EQUIVALENT DEVICE
The KFx 5.5mm Suture Lock Bone Screw Anchor is similar in basic design, technology, construction and mechanical performance to the Suture Lock Bone Anchor included in the KFx Tissue Fixation System previously cleared under 510(k) K072063. Intended use is identical. Device modifications include use of an additional biocompatible material, reduction in size, and packaging.
BIOCOMPATIBILITY AND PERFORMANCE DATA
The materials used in the KFx 5.5mm Suture Lock Bone Screw Anchor are biocompatible. The same materials are used in a myriad of legally marketed orthopedic devices.
Bench test results 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 test results demonstrate that the modified KFx 5.5mm Suture Lock Bone Screw Anchor is substantially equivalent to the currently marketed predicate device.
CONFIDENTIAL
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 9 2008
KFx Medical % Ms. Gayle Hirota QA/RA Director 5845 Avenida Encinas Suite 128 Carlsbad, CA 92008
K080229 Re:
Trade/Device Name: KFx 5.5mm Suture Lock Bone Screw Anchor, a component of the 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, HWC Dated: January 29, 2008 Received: January 30, 2008
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.
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 -- Ms. Gayle Hirota
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 M. Mellersen
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 SECTION 1.7
510(k) Number (if known):
KFx 5.5mm Suture Lock Bone Screw Anchor (component of the Device Name: KFx Tissue Fixation System and Accessories)
The KFx Tissue Fixation System (comprised of the KFx Suture Indications For Use: Lock Bone Screw Anchor and KFx Suture Lock Nail Bone Anchor) and 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, acromioclavicular 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 _ So (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)
Qabare Muehmo
Division Sign Off
Page 1 of 1
510(k) Number K080779
CONFIDENTIAL