(78 days)
The Arthrex Bio-Post and Washer is intended as an anchor device for suture or to secure soft tissue directly to bone. Specifically; Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
Arthrex, Inc. Bio-Post and Washer is intended for suture fixation or securing soft tissue to bone. The Bio-Post and Washer is composed of poly(I-lactide) acid, PLLA which is biodegradable and biocompatible. It is 35 mm in length and 6.5 mm wide at the head of the Bio-Post. The addition of the washer increases the diameter to 16.5 mm.
The provided text is a 510(k) summary for a medical device called the "Bio-Post and Washer." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with acceptance criteria.
Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, etc.) is not present in the provided document.
The document states that the device is "substantially equivalent" to predicate devices, meaning that "basic features and intended uses are the same. Minor differences... do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device." This implies that the device's performance aligns with that of already approved devices, making specific, quantifiable acceptance criteria and a standalone study proving those criteria less relevant for this type of regulatory submission.
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1 2001 AUG
K 011495
510(k) Summary
510(k) Number: Ann Waterhouse, Regulatory Affairs Specialist Contact Person: Date Prepared: April 5, 2000
Trade/Proprietary Name: Bio-Post and Washer Product Code: MAI Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue
Predicate Devices: Synthes(USA), Synthes Bioresorbable Suture Anchor, Bionx Implants, LTD., Smartwedge ACL, Bionx Implants, LTD>, Smart Screw ACL, Bionx Implants, LTD., Biocuff.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Intended Use:
The Bio-Post and Washer is intended as an anchor device for suture or to secure soft tissue directly to bone.
Description:
Arthrex, Inc. Bio-Post and Washer is intended for suture fixation or securing soft tissue to bone. The Bio-Post and Washer is composed of poly(I-lactide) acid, PLLA which is biodegradable and biocompatible. It is 35 mm in length and 6.5 mm wide at the head of the Bio-Post. The addition of the washer increases the diameter to 16.5 mm.
Substantial Equivalence:
The Arthrex, Inc. Bio-Post and Washer is substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Arthrex Bio-Post and Washer and predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.
000073
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of two.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2001 AUG
Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re: K011495
Trade Name: Arthrex Bio-Post and Washer Regulation Number: 888.3040, 888.3030 Regulatory Class: II Product Code: MAI, HWC, JDR and MNU Dated: April 04, 2001 Received: May 15, 2001
Dear Ms. Waterhouse:
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 legally marketed predicate 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 requirements, 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.
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Page 2 - Ms. Ann Waterhouse
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 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Aomhillllompton
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
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510(k) Number (if known):
Device Name: Arthrex Bio-Post and Washer
Indications for Use:
The Arthrex Bio-Post and Washer is intended as an anchor device for suture or to secure soft tissue directly to bone. Specifically;
Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MMarkle & Holm
(Division Sign-Off) Division of General, Restorative and Neurological Devices
(Option Format 3-10-98)
510(k) Number L011495
000074
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.