(89 days)
The Corifix Ligament Anchor Soft Screw is used for anterior and posterior cruciate ligament reconstruction using hamstrings. This technique provides reduced soft-tissue morbidity and reduced post operative pain on kneeling whilst improving the cosmetic appearance for the patient. The hamstring surgical technique and the Corifix Ligament Anchor Soft Screw work together for fixation of a hamstring tendon graft, without bone block, to achieve anatomic aperture fixation of the hamstring tendon graft in the tibia or femur.
The Corifix ligament Anchor is a headless, tapered, round threaded, cannulated screw manufactured from titanium alloy (6A1 4V) which conforms to BS 7252/3 and ASTM 136/96. The screw has a 3.5mm hex drive. The Ligament Anchor Soft Screw has been on the foreign (i.e. non-US) market since January 1997, since that date approximately 1,700 screws have been implanted. The Corifix Ligament Anchor Soft Screw has a rounded thread to prevent damage to the graft, is cannulated and tapered to aid insertion, and has a 3.5mm hex drive. The Corifix Ligament Anchor Soft Screw is available in four diameters i.e 7mm, 9mm & 10 mm, for each diameter of screw four lengths of screw are available i.e. 20mm, 25mm, 30mm, & 35 mm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Corifix Ligament Anchor Soft Screw:
It's important to note that the provided text is a 510(k) summary for a medical device submitted to the FDA for market clearance, not a detailed study report. Therefore, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical or standalone performance study in the way a clinical trial or AI algorithm validation would.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance | Study Type/Evidence |
|---|---|---|
| Material Conformance | Titanium Alloy 6A14V conforms to BS 7252/3 and ASTM 136/96. | Material certification and testing |
| Fixation Strength (Mechanical) | Fixation strength: 691N | Independent mechanical testing |
| Load Bearing (Clinical Loads) | Maximum expected clinical loads: 150N (walking), 450N (jogging) | Not explicitly stated how these "expected clinical loads" were determined, but likely based on biomechanical literature or predicate device characterization. |
| Functionality (Graft Protection) | Rounded thread to prevent damage to the graft. | Device design feature, implicitly verified by mechanical testing using relevant loads or through comparison with predicate. |
| Functionality (Ease of Insertion) | Cannulated and tapered to aid insertion. | Device design feature, implicitly verified by comparison with predicate. |
| Safety (Clinical Use) | Approximately 1,700 screws implanted on foreign (non-US) market since January 1997 without reported issues. | Retrospective market experience (foreign) |
| Substantial Equivalence to Predicate | Comparable features to Smith & Nephew RCI Screw (rounded thread, cannulated, 6AI4V, 3.5mm hex drive, tapered). Advantage: wider range of sizes. | Comparison of design features and materials. |
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: For the mechanical testing, the text states "Independent mechanical testing of the most popular sizes of screw determined..." It does not specify the exact number of screws or tests performed.
- Data Provenance: The mechanical testing was described as "Independent mechanical testing," implying an external lab. The clinical experience data (1,700 implanted screws) is from the "foreign (i.e. non-US) market."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- For the mechanical testing, the "ground truth" is based on engineering standards and direct physical measurement of fixation strength. Experts would be mechanical engineers or biomechanical researchers, but their specific number or qualifications are not stated as they are not establishing subjective ground truth from data.
- For the clinical use, no "ground truth" derived from expert consensus on a test set is described. The 1,700 implants represent real-world use, and the absence of reported issues implicitly serves as a form of "ground truth" for safety/functionality.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication method is used for subjective evaluations (e.g., image interpretation). Mechanical testing relies on objective measurements that do not require human adjudication in this sense.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a surgical implant, not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. However, its "standalone" performance can be considered its mechanical strength and material properties.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Material: Conformance to established international and national standards (BS 7252/3 and ASTM 136/96).
- Mechanical Performance: Direct physical measurements of fixation strength compared against biomechanically derived "expected clinical loads."
- Clinical Efficacy/Safety (implicit for 510k): Real-world outcomes data from the foreign market (1,700 implants without issues) implying acceptable safety and performance. This is not a controlled outcomes study, but rather a report of post-market experience.
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The sample size for the training set:
- Not applicable. This is a physical device, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable as there is no training set.
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510(k) SUMMARY MAR - 6 2000
Corifix Name of Company:
The Corinium Centre Cirencester Gloucestershire GL7 1YJ England
Name of Device:
Ligament Anchor Soft Screw .
Device Description:
The Corifix ligament Anchor is a headless, tapered, round threaded, cannulated screw manufactured from titanium alloy (6A1 4V) which conforms to BS 7252/3 and ASTM 136/96. The screw has a 3.5mm hex drive.
The Ligament Anchor Soft Screw has been on the foreign (i.e. non-US) market since January 1997, since that date approximately 1,700 screws have been implanted.
Intended Use.
The screws are used in anterior cruciate ligament and posterior cruciate ligament reconstruction using hamstrings. This device may also be used for bone patellar tendon bone fixation.
The soft screw provides solid fixation of the ligament without damaging grafts or the need for pre-tapping, thus avoiding damage to the hamstring grafts.
The ligament anchor soft screw can be used in both the femur and tibia or in conjunction with the Corifix Ligament Anchor which is already 510k approved. (
Material.
The material used for the Ligament Anchor Soft Screw is Titanium Alloy 6A14V, certified to BS 7252:Pt. 3:1997 Metallic materials for surgical implants - Specification for wrought titanium 6-Aluminium 4-Vanadium alloy and ASTM F136-96 Wrought Titanium-6Aluminium-4Vanadium ELI.
Device Geometry.
The Corifix Ligament Anchor Soft Screw has a rounded thread to prevent damage to the graft, is cannulated and tapered to aid insertion, and has a 3.5mm hex drive.
Sizes
The Corifix Ligament Anchor Soft Screw is available in four diameters i.e 7mm, 9mm & 10 mm, for each diameter of screw four lengths of screw are available i.e. 20mm, 25mm, 30mm, & 35 mm.
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Summary of Mechanical Testing (Further details provided on Page 14 of this dossier).
The titanium alloy 6A14V from which the Corifix Ligament Anchor Soft Screw is manufactured is tested and certified to BS 7252:Pt. 3:1997 Metallic Materials for Surgical Implant -Specification for wrought titanium 6-Aluminium 4-Vanadium alloy and ASTM F136-96 Wrought Titanium-6Aluminium-4Vanadium ELI.
Independent mechanical testing of the most popular sizes of screw determined that the maximum expected clinical loads applied to this device are 150N during walking and 450N during jogging. The fixation strength of the Corifix Ligament Anchor Soft Screw was found to be 691N.
Device to which Substantial Equivalence is Claimed and Device Specific Features
Substantial equivalence for the Corifix Ligament Anchor Soft Screw is claimed with the Smith & Nephew RCI Screw, which has been in clinical use within the USA for 5 years. (Predicate Device No. K947134).
The comparable features of the RCI Screw & Corifix Ligament Anchor Soft Screw are that both screws have a rounded thread, are cannulated, made of titanium alloy 6AI4V, have a 3.5mm hex. drive and are tapered to aid insertion. The advantage of the Corifix Ligament Anchor Soft Screw is that it is available in a range of sizes.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 6 2000
Mr. Craig Corrance President Corin U.S.A. 10500 University Center Drive Suite 130 Tampa, Florida 33612
Re: K994152
Trade Name: Corafix Ligament Anchor Soft Screw Regulatory Class: II Product Code: HWC Dated: November 18, 1999 Received: December 8, 1999
Dear Mr. Corrance:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Mr. Craig Corrance
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Russell Jager
& James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510k Number (of known): Prov. - K994152
Device Name :- Corifix Ligament Anchor Soft Screw.
INDICATIONS FOR USE
The Corifix Ligament Anchor Soft Screw is used for anterior and posterior cruciate ligament reconstruction using hamstrings.
This technique provides reduced soft-tissue morbidity and reduced post operative pain on kneeling whilst improving the cosmetic appearance for the patient.
The hamstring surgical technique and the Corifix Ligament Anchor Soft Screw work together for fixation of a hamstring tendon graft, without bone block, to achieve anatomic aperture fixation of the hamstring tendon graft in the tibia or femur.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE).
Russell Rogers
e
Prescription Use (Per 21 CFR 801.109)
N/A