(29 days)
No
The device description focuses solely on the mechanical design and materials of a bone screw system for ACL reconstruction. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The bone mulch screw system is indicated for use in fixing a graft in ACL reconstruction, which is a structural or mechanical function, not a therapeutic one.
No
The provided text describes a medical device, the Bone Mulch Screw System, which is used for fixing grafts in ACL reconstruction. It details the device's components, materials, and how it functions as an implant. There is no information suggesting that this device is used for diagnosing conditions or diseases.
No
The device description clearly details physical components made of titanium alloy and UHMWPE, which are hardware materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant (Bone Mulch Screw System) used to fix a tendon graft during ACL reconstruction surgery. It is a physical device implanted into the body.
- Intended Use: The intended use is to fix a graft within the femoral graft tunnel, which is a surgical procedure performed directly on the patient's body.
The device's function is mechanical and structural within the body, not the analysis of biological specimens outside the body.
N/A
Intended Use / Indications for Use
The Bone Mulch Screw System is indicated for use in anterior cruciate ligament (ACL) reconstruction using semigracilis/semitendinosus or fasc ... !ata (namstring tendons) graft. It is intended for use in fixing the graft within the femoral graft tunnel.
Product codes
87HWC
Device Description
The predicate Bone Mulch Screw System consists of three different Bone Mulch Screws made of Titanium alloy Ti-6A1-4V per ASTM F-136 which are available in different lengths as well as cannulated and noncannulated configurations. The Cannulated Bone Mulch Screw is comprised of two components, the cannulated screw and either a titanium screw plug or an UHMWPE plug. The cannulated screw portion has a blunt nose, available in a standard or +5mm length, which resides across the femoral bone tunnel. The tendon graft is wrapped over this portion of the cannulated screw and never comes in contact with the threads of the cannulated screw. The larger threaded, portion of the cannulated screw resides in the femoral bone adjacent to the tunnel and acts as a passageway for bone graft. The opening in the cannulated screw just prior to the blunt nose allows for passage of bone graft to lie adjacent to the tendon graft to aid in graft incorporation. The bone graft material is pushed into the bone tunnel by a graft insertion rod. The bone graft material is secured at the reconstruction site by inserting either the titanium screw plug or the UHMWPE plug into the hollow end of the screw. The UHMWPE plug is designed to allow the surgeon to insert it with the graft insertion rod. The non-cannulated Bone Mulch Screw is identical to the cannulated Bone Mulch Screw in design and function but is solid and does not require bone graft to be packed inside it.
The modified design continues the cannulation into the nose allowing the screw to be passed over a wire . The added length to the tip will cause the screw to go deeper into the medial wall of the graft tunnel thereby preventing the most likely failure mode of the screw - the tip being p ' ''ed downward into the tunnel in a cantilever manner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral graft tunnel
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)
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
INTRODUCTORY INFORMATION
Sponsor: Biomet, Inc.
Manufacturer: Biomet Manufacturing, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587
Establishment Registration: 1825034
Contact Person: Fred McClure (219) 372-1568
Distributor: Arthrotek Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587
Devices are manufactured and packaged in the Warsaw, Indiana facility which is also the headquarters of Biomet, Inc.
The device will be distributed by Arthrotek, a wholly owned subsidiary of Biomet, Inc.
Proprietary Name: Bone Mulch Screw System
Common or Usual Name: ACL Graft Femoral Fixation Screw
Classification Name: Screw, Fixation, Bone
Device Classification: 21 CFR 888.3040
Device Product Code: 87HWC
Performance Standards/Guidance Documents: No performance standards have been developed for this type of device
Previous FDA Status: Devices from this system were previously cleared in 510(k) K941941 and K991298.
Device Description: The predicate Bone Mulch Screw System consists of three different Bone Mulch Screws made of Titanium alloy Ti-6A1-4V per ASTM F-136 which are available in different lengths as well as cannulated and noncannulated configurations. The Cannulated Bone Mulch Screw is comprised of two components, the cannulated screw and either a titanium screw plug or an
1
UHMWPE plug. The cannulated screw portion has a blunt nose, available in a standard or +5mm length, which resides across the femoral bone tunnel. The tendon graft is wrapped over this portion of the cannulated screw and never comes in contact with the threads of the cannulated screw. The larger threaded, portion of the cannulated screw resides in the femoral bone adjacent to the tunnel and acts as a passageway for bone graft. The opening in the cannulated screw just prior to the blunt nose allows for passage of bone graft to lie adjacent to the tendon graft to aid in graft incorporation. The bone graft material is pushed into the bone tunnel by a graft insertion rod. The bone graft material is secured at the reconstruction site by inserting either the titanium screw plug or the UHMWPE plug into the hollow end of the screw. The UHMWPE plug is designed to allow the surgeon to insert it with the graft insertion rod. The non-cannulated Bone Mulch Screw is identical to the cannulated Bone Mulch Screw in design and function but is solid and does not require bone graft to be packed inside it.
The modified design continues the cannulation into the nose allowing the screw to be passed over a wire . The added length to the tip will cause the screw to go deeper into the medial wall of the graft tunnel thereby preventing the most likely failure mode of the screw - the tip being p ' ''ed downward into the tunnel in a cantilever manner.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 8 1999
Mr. Fred McClure Regulatory Specialist Biomet, Inc. Airport Industrial Park P. O. Box 587 Warsaw, Indiana 46581-0587
Re: K993025
Trade Name: Bone Mulch Screw System Regulatory Class: II Product Code: HWC Dated: August 19, 1999 Received: September 09, 1999
Dear Mr. McClure:
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 enclosures) 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 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 (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.
3
Page 2 - Mr. Fred McClure
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 vour device to proceed to the market.
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) 594-4595. 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 (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
Enclosures
4
510 (k) Number (if known) : _
Bone Mulch Screw System Device Name:
The Bone Mulch Screw System is indicated for use Indications For Use: in anterior cruciate ligament (ACL) reconstruction using semigracilis/semitendinosus or fasc ... !ata (namstring tendons) graft. It is intended for use in fixing the graft within the femoral graft tunnel.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
(Per 21 CFR 801.109)
colle
Divisio f General Restorative I 510(k) Numbe 008