(90 days)
Not Found
No
The provided text describes a mechanical surgical tack and its intended use for shoulder repair. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is described as facilitating soft tissue reattachment and providing secure tissue stabilization throughout the healing period for shoulder injuries, which falls under therapeutic use.
No
The device is described as a surgical tack for fixation of soft tissue to bone, used in the repair of shoulder injuries. Its intended use is to maintain proximity between soft tissue and bone, not to diagnose a condition.
No
The device description clearly describes a physical, cannulated tack with a round head and scaled edges, indicating it is a hardware implant, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Bionx Bankart Tack Function: The description clearly states the Bionx Bankart Tack is a device used for internal fixation of soft tissue to bone during surgery to repair shoulder injuries. It is implanted inside the body to physically hold tissues together.
The intended use, device description, and surgical application all point to this being a surgical implant, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Bionx Bankart Tack is an absorbable device which is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Bionx Bankart Tack will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions). When used in conjunction with appropriate postoperative immobilization, the Bionx Bankart Tack provides secure tissue stabilization throughout the healing period.
Product codes
MAI, HWC
Device Description
The Bionx Bankart Tack is a cannulated tack with a round head and four circumferential rows of scaled edges along the distal end to securely fix the tack in the bone.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Shoulder
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
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Summary of Performance Studies
Performance testing and clinical studies have demonstrated that the insertion technique for the Bionx Bankart Tack provides adequate fixation for this intended use.
The biocompatibility and strength of the PLLA and polyglyconate materials were demonstrated in clinical studies and performance testing.
Performance testing and clinical studies confirmed that the minor differences in the technical characteristics of the devices do not raise new questions of safety or effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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JAN - 6 1998
510(K) SUMMARY FOR THE BIONX IMPLANTS, INC.
BIOABSORBABLE BANKART TACK
Submitter's Name, Address, Telephone Number, And Contact Person
Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Bluebell, PA 19422
| Contact: | David W. Anderson
President and CEO |
|------------|----------------------------------------|
| Phone: | (215) 643-5000 |
| Facsimile: | (215) 653-0984 |
Date Prepared
October 7, 1997
Name of the Device
Bioabsorbable Bankart Tack
Common or Usual Name
Bionx Bankart Tack
Classification Name
Biodegradable Soft Tissue Fixation Fastener
Predicate Device
Acufex Microsurgical Inc. Suretac® Polyglyconate Absorbable Fixator (K911837)
DePuy, Inc. DuPont Phantom Suture Anchor (K964521)
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Intended Use
The Bionx Bankart Tack is an absorbable device which is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Bionx Bankart Tack will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions). When used in conjunction with appropriate postoperative immobilization, the Bionx Bankart Tack provides secure tissue stabilization throughout the healing period.
Principles of Operation
The Bionx Bankart Tack may be used in either open or arthroscopic surgical procedures. To use the Bionx Bankart Tack, the surgeon must first examine the shoulder joint to identify the site of the labral detachment, note any stretching within the capsule and ligaments, and ascertain the degree and direction of the instability. After the damaged soft tissue is properly aligned for reattachment to the bone, the Bionx Bankart Tack is then inserted through the labrum into a predrilled hole over a guide wire. The guide wire is removed, and the position of the tack is examined anteriorly to ensure that the soft tissue is securely fixed to the bone. Substantially the same approach is followed to insert the Acufex Suretac, and similar techniques are used to insert the DuPont Phantom.
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Technical Characteristics
The Bionx Bankart Tack, the Acufex Suretac, and the DuPont Phantom are intended for use in the fixation of soft tissue to bone in the repair of shoulder injuries. The Bankart Tack is a cannulated tack with a round head and four circumferential rows of scaled edges along the distal end to securely fix the tack in the bone. Like the Bionx Bankart Tack, the Acufex Suretac is a cannulated tack with a round head; however, the Suretac utilizes three raised rings along the circumference of the tack located in the middle of the shaft to fix the tack in the bone, as opposed to the scaled edges utilized by the Bankart Tack. The DuPont Phantom is secured in the bone by threading.
The Bionx Bankart Tack has substantially the same design configuration as the predicates with the exception of having scaled edges as opposed to raised rings or threading to secure the tack in the bone, and slightly different dimensions. These minor differences in design configuration do not raise any new issues of safety and effectiveness because all of the devices are secured in the bone by the same mechanism. Moreover, the question of whether the method of securing the device in the bone is sufficiently strong for this intended use is common to all of the devices.
To ensure proper alignment and fixation, the devices are each supplied with several customized insertion tools. The accompanying tools for both the Bankart Tack and the Suretac are substantially the same, and both sets of tools are
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manufactured from stainless steel and plastic. The minor differences in the insertion tools of the Bionx Bankart Tack and the Acufex Suretac do not raise any new issues of safety and effectiveness because the principles of operation and method of insertion of the two devices is the same. Additionally, performance testing and clinical studies have demonstrated that the insertion technique for the Bionx Bankart Tack provides adequate fixation for this intended use.
All of the devices are manufactured from absorbable polymers which degrade over time and are absorbed by the body. The Bionx Bankart Tack and the DuPont Phantom are made of poly-L-lactide (PLLA) polymer, while the Acufex Suretac is made of polyglyconate, which is a copolymer of polyglycolic acid and trimethylene carbonate. Both the PLLA and polyglyconate materials are biocompatible and possess sufficient strength for this intended use, as demonstrated in clinical studies and performance testing. Additionally, Bionx has previously received clearance from FDA to market other implanted pins and rods made from the same PLLA polymer used in the Bionx Bankart Tack.
Summary Basis for the Finding of Substantial Equivalence
Like the previously cleared Acufex Suretac and DuPont Phantom, the Bionx Bankart Tack is intended for use to reattach soft tissue to bone in the repair of shoulder injuries. All of the devices are specifically indicated for use in the repair of Bankart lesions. Furthermore, all of the devices have very similar principles of operation and technical characteristics. The minor differences in the technical characteristics of the devices do not raise new questions of safety or effectiveness, as
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confirmed by performance testing and clinical studies. Thus, the devices are substantially equivalent.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing health, human services, and well-being. 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
JAN - 6 1000
Mr. Jonathan S. Kahan · Partner Hogan & Hartson, L.L.P. Representing Bionx Implants, Inc. 555 Thirteenth Street, N.W. Columbia Square
Washington, DC 20004-1109
Re: K973849 Trade Name: Bioabsorbable Bankart Tack Regulatory Class: II Product Codes: MAI and HWC Dated: October 8, 1997 Received: October 8, 1997
Dear Mr. Kahan:
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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 requlations 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 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.
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510(k) Number (if known):_K973849
Device Name: Bionx Bankart Tack Indications For Use:
The Bionx Bankart Tack is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Bionx Bankart Tack will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
coel a
neral Restorative Devir
Prision of General Restorative Device (10-ugic noisivid)
Prescription Use (Per 21 CFR 801.109)
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OR
Over-The-Counter Use
(Optional Format 1-2-96)