(90 days)
Not Found
Not Found
No
The summary describes a mechanical screw for bone fixation and does not mention any AI or ML components or functionalities.
Yes.
This device is designed to treat Type IIIB ACL avulsions by providing fixation of bone to bone, which is a therapeutic intervention.
No
Explanation: The device is an orthopedic screw designed for fixation of bone to bone in repairing ACL avulsions; it performs a therapeutic function and does not diagnose a condition.
No
The device description clearly describes a physical screw intended for surgical fixation of bone, not a software product.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is a "Lag Screw" intended for "fixation of bone to bone" in the context of repairing ACL avulsions. This is a surgical implant used directly within the body.
- Intended Use: The intended use is for a surgical procedure to fix a bone fragment, not to analyze a sample outside the body.
Therefore, the ACL Avulsion Lag Screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACL Avulsion Lag Screw is intended for fixation of bone. This product is intended for use in repairing Type IIIB ACL avulsions.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
A key to treating ACL avulsions is to determine whether the bony fragment is large enough to support internal fixation. The Arthrex Avulsion Lag Screw is specifically designed to allow rigid internal fixation of smaller bony fragments than has been possible with traditional screw designs. Because the avulsion screw is a cancellous bone screw, the risk of damage to the posterior neurovascular structures is minimized. If the fragment is too small, the transtibial suture technique should be used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone (specifically for Type IIIB ACL avulsions)
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)
Not Found
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.
Not Found
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
1998 . Ut
510(k) Summary
3/24/98
| Company: | Arthrex, Inc. |
|---|---|
| Address: | 2885 S. Horseshoe Drive, Naples, FL 34104 |
| Phone: | (941) 643-5553 |
| Fax: | (941) 643-6218 |
| Contact: | Scott M. Durlacher |
| Director of Regulatory Affairs and Quality Assurance (ext. 117) |
| Trade Name: | ACL Avulsion Lag Screw with Sheath |
|---|---|
| Common Name: | Bone Screw |
| Classification: | Screw, Fixation, Bone |
Description:
A key to treating ACL avulsions is to determine whether the bony fragment is large enough to support internal fixation. The Arthrex Avulsion Lag Screw is specifically designed to allow rigid internal fixation of smaller bony fragments than has been possible with traditional screw designs. Because the avulsion screw is a cancellous bone screw, the risk of damage to the posterior neurovascular structures is minimized. If the fragment is too small, the transtibial suture technique should be used.
Intended Use:
The ACL Avulsion Lag Screw is intended for fixation of bone. This product is intended for use in repairing Type IIIB ACL avulsions
Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device.
A substantial equivalence comparison is given in the table below. In regards to the material, the titanium alloy 6AL-4V ELI used to manufacture the Arthrex ACL Avulsion Lag Screw meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F136).
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| Company | Device | Intended Use | Material |
|---|---|---|---|
| Arthrex | ACL Avulsion Lag | ||
| Screw | Fixation of bone to bone - repairing | ||
| Type IIIB ACL avulsions | Titanium alloy | ||
| per ASTM F136 | |||
| Acumed | 2.7mm Extremity Bone | ||
| Screw | Fixation of bone to bone - fracture | ||
| and osteotomy fixation of the upper | |||
| and lower extremities | Titanium alloy | ||
| per ASTM F136 | |||
| Aesculap | Titanium Alloy Bone | ||
| Screw | Fixation of bone to bone - fixation | ||
| of long and small bone fractures | Titanium alloy |
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2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1998 JUL
Mr. Scott M. Durlacher · Director of Regulatory Affairs and Quality Assurance Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re : K981187 ACL Avulsion Laq Screw with Sheath Requlatory Class: II Product Code: HWC Dated: March 24, 1998 Received: April 2, 1998
Dear Mr. Durlacher:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the merice is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate ase stated in the enclobals, so 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 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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of This device, if intended for use in pedicular screw the Act. fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to Accordingly : marketing.
- The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and
- You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the
3
Page 2 - Mr. Scott M. Durlacher
- package insert must include the following statement, 3. "WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may Existing major be subject to such additional controls. requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
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Page 3 - Mr. Scott M. Durlacher
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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in bold, black letters. The "x" in "Arthrex" is stylized to resemble a surgical instrument. The surgical instrument is also black and is positioned diagonally across the "x".
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Indications for Use
The ACL Avulsion Lag Screw is intended for fixation of bone to bone. This product is intended for use in repairing Type IIIB ACL avulsions.
Prescription Use
(Per 21 CFR 801.109)
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Division of General Restorative Devices
510(k) Number K981187
(S)