(43 days)
Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
Various style titanium alloy and stainless steel screws and washers. Screw diameters range from 3.5mm to 6.5mm and 10mm to 60mm in length. Washers have posts or spikes to engage the bone.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter for the "WasherLoc™ Screw System" and related soft tissue fixation screws. It discusses the regulatory classification, intended use, and general controls provisions of the Medical Device Amendments, but it does not detail any specific performance acceptance criteria or the results of a study designed to demonstrate them.
{0}------------------------------------------------
JUL 17 1998
Image /page/0/Picture/1 description: The image shows the logo for Biomet Inc. The logo is in black and white and features the company name in a stylized font. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller font.
SUMMARY OF SAFETY AND EFFECTIVENESS
Arthrotek Sponsor: Airport Industrial Park Warsaw, Indiana 46580
WasherLoc™ Screw System Proprietary Names: Ligament Screw System No-Profile™ Bi-Cortical Screw System Channel Ligament Clamp Heckman™ Screw System
Common or Usual Name: Soft tissue fixation screws
Classification Name: Single/multiple component metallic bone fixation appliances and accessories (21 C.F.R. §888.3030)
Device Classification: Class II
Device Product Code: 87MBI - Fastener, nondegradable, soft tissue
Intended Use: Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
Device Description: Various style titanium alloy and stainless steel screws and washers. Screw diameters range from 3.5mm to 6.5mm and 10mm to 60mm in length. Washers have posts or spikes to engage the bone.
| Substantially Equivelent Devices: | |
|---|---|
| Cancellous Fixation Screw & Washer (Concept, Inc.) | K871037 |
| (now marketed by Linvatec) | |
| MLI Soft Tissue Screw & Washer (Medicine Lodge, Inc.) | K962194 |
| (now marketed by Innovasive) | |
| SMo Bone Screws (OEC) | Preamendment |
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
1
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
1
()FFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the top half and "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the bottom half. In the center of the seal is a stylized image of an eagle.
JUL 1 7 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
·Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
Re : K981967 Trade Name: WasherLoc™, Ligament Washer, Lo-Profile™, Heckman™, and Channel Ligament Screw Systems Regulatory Class: II Product Codes: MBI and HWC Dated: June 2, 1998 Received: June 4,1998
Dear Ms. Beres:
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, 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 marketing. Accordingly :
- The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and
{2}------------------------------------------------
Paqe 2 - Ms. Patricia Sandborn Beres
- You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the If this cervical, thoracic or lumbar vertebral column. device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, This device is not approved for screw "WARNING: 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 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. 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 requlation (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 In addition, FDA may publish further announcements action. 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 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 .
{3}------------------------------------------------
Page 3 - Ms. Patricia Sandborn Beres
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 compriation 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 the regulation entification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information of Joursion of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at at fes corrires namber (65)/ 355fda.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 Radioloqical Health
Enclosure
{4}------------------------------------------------
510 (k) Number (if known): (~. ~ ) ~ = = =
Device Name: Soft Tissue Fixation Screws
Indications For Use:
Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
District Mining Off
(Division ign-Off Division o General Restora 510(k) Number
OR
Prescription Use
(Per 21 CFR 801.109) X
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 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.