(29 days)
Not Found
No
The description focuses on the mechanical components and materials of a surgical screw system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a "Bone Mulch Screw System" used to fix a graft during ACL reconstruction. Its function is mechanical fixation rather than directly treating or mitigating a disease or condition for therapeutic effect.
No
The device is a surgical implant (Bone Mulch Screw System) used in ACL reconstruction for fixing grafts, not for diagnosing medical conditions.
No
The device description explicitly details physical components made of titanium alloy and UHMWPE, indicating it is a hardware medical device, not software-only.
No, 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, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The Bone Mulch Screw System is a surgical implant used to fix a graft within the femoral tunnel during ACL reconstruction. It is a physical device implanted into the body.
- Intended Use: The intended use is for surgical fixation of a graft, not for testing biological samples.
The description clearly indicates a surgical implant used for mechanical support and fixation within the body, which falls under the category of a medical device, but not an In Vitro Diagnostic.
N/A
Output:
Intended Use / Indications for Use
The Bone Mulch Screw System is indicated for use in anterior cruciate ligament (ACL) reconstruction using semigracilis/semitendinosus or fascia lata (hamstring tendons) graft. It is intended for use in fixing the graft within the femoral graft tunnel.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Bone Mulch Screw System consists of three different Bone Mulch Screws made of Titanium alloy, available in different lengths as well as cannulated and non-cannulated configurations, a titanium screw plug and an UHMWPE plug. The blunt nose of the screw transverses the femoral tunnel allowing for femoral fixation of the ACL graft. With the graft wrapped over the blunt nose of the screw, the larger portion of the cannulated screw is packed with bone graft material. The bone graft material is pushed into the tunnel by a graft insertion rod and secured in place with either the titanium screw plug or the UHMWPE plug. The non-cannulated screw is used in the same manner but does not require the addition of bone graft to fill the screw.
The Bone Mulch Screw and titanium screw plug is made of titanium alloy Ti-6Al-4V per ASTM F136 and the poly plug is made of UHMWPE. These materials have been successfully used as implantable materials for the past several decades. The biocompatibility and wear properties have been established by many years of usage in medical devices.
Mechanical testing of this device demonstrated more than adequate strength for this ACL reconstruction indication. In summary, the device is made of biocompatible materials and is able to withstand loads greater than those expected in an intact ACL.
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)
Mechanical testing of this device demonstrated more than adequate strength for this ACL reconstruction indication.
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
Sponsor:
SUMMARY OF SAFETY AND EFFECTIVENESS
| Biomet, Inc. | |
|---|---|
| Airport Industrial Park | |
| Warsaw, Indiana 46580 |
Bone Mulch Screw Device:
Classification Name: Screw, Fixation, Bone
Intended Use: The Bone Mulch Screw System is indicated for use in anterior cruciate ligament (ACL) reconstruction using semigracilis/semitendinosus or fascia lata (hamstring tendons) graft. It is intended for use in fixing the graft within the femoral graft tunnel.
Device Description: The Bone Mulch Screw System consists of three different Bone Mulch Screws made of Titanium alloy, available in different lengths as well as cannulated and non-cannulated configurations, a titanium screw plug and an UHMWPE plug. The blunt nose of the screw transverses the femoral tunnel allowing for femoral fixation of the ACL graft. With the graft wrapped over the blunt nose of the screw, the larger portion of the cannulated screw is packed with bone graft material. The bone graft material is pushed into the tunnel by a graft insertion rod and secured in place with either the titanium screw plug or the UHMWPE plug. The non-cannulated screw is used in the same manner but does not require the addition of bone graft to fill the screw.
The Bone Mulch Screw and titanium screw plug is made of titanium alloy Ti-6Al-4V per ASTM F136 and the poly plug is made of UHMWPE. These materials have been successfully used as implantable materials for the past several decades. The biocompatibility and wear properties have been established by many years of usage in medical devices.
Mechanical testing of this device demonstrated more than adequate strength for this ACL reconstruction indication. In summary, the device is made of biocompatible materials and is able to withstand loads greater than those expected in an intact ACL.
Possible Adverse Effects:
-
- Inadequate healing which may lead to breakage of the implant.
-
- Fracture of the implant due to excessive activity.
-
- Loosening and/or migration of the implant.
-
- Metal sensitivity, or allergic reaction to a foreign body.
-
- Pain, discomfort or abnormal sensations due to the presence of the device.
-
- Nerve damage due to surgical trauma.
-
- Necrosis of bone or bone resorption.
-
- Necrosis of tissue or inadequate healing.
Substantial Equivalence: In function and overall design the Prosthesis is equivalent to
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread, with three human profiles superimposed on the eagle's body. The image is black and white.
MAY 1 4 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Fred McClure Requlatory Specialist Biomet, Inc. Airport Industrial Park P.O. Box 587 46581-0587 Warsaw, Indiana
K991298 Re: Bone Mulch Screw System Trade Name: Requlatory Class: II Product Code: HWC April 13, 1999 Dated: Received: April 15, 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 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 controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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 Requlations, 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 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 requlation 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 requlations.
2
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 your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (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 (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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Page 1_of _1
K991298 510 (k) Number (if known) : _
Bone Mulch Screw System Device Name:
The Bone Mulch Screw System is indicated for use in anterior cruciate ligament Indications For Use: (ACL) reconstruction using semigracilis/semitendinosus or fascia lata (hamstring tendons) graft. It is intended for use in fixing the graft within the femoral graft tunnel.
Prescription Use
(Per 21 CFR 801.109)
picasso
(Division Division of Ganaral Ro 510(k) Numb
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