(220 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a physical suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates fixation of tissue to bone, which is a structural or supportive function, rather than a direct therapeutic action like healing or diagnosing a disease.
No
The device is a suture anchor intended for fixation of tissue to bone during surgical repairs, not for diagnosing medical conditions.
No
The device description clearly describes a physical implantable medical device made of titanium alloy and PLA, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "fixation of tissue to bone" for various surgical procedures. This is a mechanical function performed in vivo (within the body).
- Device Description: The description details a physical implantable device made of titanium alloy and PLA, designed for surgical insertion.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Parachute Corkscrew Suture Anchor is intended for fixation of tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps 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: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction
Product codes (comma separated list FDA assigned to the subject device)
MBI and GAT
Device Description
The Parachute Corkscrew Suture Anchor is a 2 component product consisting of a titanium alloy anchor with a PLA disc attached by a #4 non-absorbable braided polyester suture. Once the tissue is in the desired position, the Parachute Corkscrew is inserted through the tissue and into bone. The insertion is discontinued when the soft tissue/bone apposition has been achieved. The distance between the disk and anchor ensures that the head of the anchor is not protruding from the surface of the bone.
The anchor is made of Titanium 6AI-4V alloy (ASTM F136-96), the biocompatibility of which has been well documented. In regards to the material for the disc, Poly (L-lactide), it is currently being used in the Arthrex Bio-Interference Screw, which has received clearance for both bone and soft tissue fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Hand/Wrist, Elbow
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)
A substantial equivalence comparison is given in Table A. Although there are slight differences in design and failure strength between the various anchors, the critical value for the FASTak and Bio-Anchor is the tensile strength of the suture. Since the failure strength of the Parachute Corkscrew is greater than the knot tensile strength of size 2 suture (i.e. the maximum recommended size of suture for both the FAStak and the Bio-Anchor), none of the aforementioned differences make it any less safe and effective than the predicate devices. Furthermore, they do not raise any different questions regarding safety and effectiveness from the predicate devices.
Testing performed using a 20 lb. density foam block to simulate poor quality bone.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Failure Strength of Parachute Corkscrew: 40.98 lbs.
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.
Not Found
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
AUG 6 1998
510(k) Summary
12/24/97
| Company: | Arthrex, Inc. |
|---|---|
| Address: | 2885 S. Horseshoe Drive, Naples, FL 34104 |
| Phone: | (941) 643-5553 |
| Fax: | (941) 643-6218 |
| Contact: | Scott M. Durlacher |
| Director of Regulatory Affairs and Quality Assurance (ext. 117) | |
| Trade Name: | Arthrex Parachute Corkscrew Suture Anchor |
| Common Name: | Suture Anchor |
| Classification: | Fastener, Fixation, Nondegradable, Soft Tissue (per 21 CFR 888.3030) |
| Fastener, Fixation, Biodegradable, Soft Tissue |
Description:
The Parachute Corkscrew Suture Anchor is a 2 component product consisting of a titanium alloy anchor with a PLA disc attached by a #4 non-absorbable braided polyester suture. Once the tissue is in the desired position, the Parachute Corkscrew is inserted through the tissue and into bone. The insertion is discontinued when the soft tissue/bone apposition has been achieved. The distance between the disk and anchor ensures that the head of the anchor is not protruding from the surface of the bone.
The anchor is made of Titanium 6AI-4V alloy (ASTM F136-96), the biocompatibility of which has been well documented. In regards to the material for the disc, Poly (L-lactide), it is currently being used in the Arthrex Bio-Interference Screw, which has received clearance for both bone and soft tissue fixation.
Intended Use:
The Parachute Corkscrew Suture Anchor is intended for fixation of tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps 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: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
1
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction
Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device.
A substantial equivalence comparison is given in Table A. Although there are slight differences in design and failure strength between the various anchors, the critical value for the FASTak and Bio-Anchor is the tensile strength of the suture. Since the failure strength of the Parachute Corkscrew is greater than the knot tensile strength of size 2 suture (i.e. the maximum recommended size of suture for both the FAStak and the Bio-Anchor), none of the aforementioned differences make it any less safe and effective than the predicate devices. Furthermore, they do not raise any different questions regarding safety and effectiveness from the predicate devices.
2
Table A: Substantial
| Company | Device | Intended Use | Material |
|---|---|---|---|
| Arthrex | Parachute | ||
| Corkscrew | Soft tissue to | ||
| bone fixation | Anchor: titanium a | ||
| Disc: Poly (L-lactic) acid | |||
| Arthrex | FASTak | Soft tissue to | |
| bone fixation | Titanium Alloy | ||
| Linvatec | Bio-Anchor | Soft tissue to | |
| bone fixation | Poly (L-lactic) acid |
- Testing performed using a 20 lb. density foam block to simulat
** "Suture Anchors Product Information Guide" – Orthopedic Sy
.
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.
“Suture Anchors Product Information Guide” – Orthopedic S
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3
Equivalence Comparison
(
: 上一篇:
| Size(s) | Insertion | Failure Strength | |
|---|---|---|---|
| lloy | |||
| de) | 3.5mm w/8mm PLA disc | ||
| 5.0mm w/8mm PLA disc | Screw in | 40.98 lbs.* | |
| 2.4mm w/#2 suture | Screw in | 55.40 lbs.* | |
| ð | 3.5mm w/#0 to #2 suture | Impact | Diaphyseal: 33 lbs.** |
| Metaphyseal: 49 lbs. | |||
| Cancellous: 29 lbs. |
.
. . .
.
te poor quality bone pecial Edition: Winter/Spring 1997
:
and the same of the same of the seat of the seat
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is an abstract emblem featuring an eagle with its wings spread, with three human profiles incorporated into the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 6 1998
Mr. Scott M. Durlacher · Director of Regulatory Affairs and Quality Assurance Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104
K974847 Re: Arthrex Parachute Corkscrew Suture Anchor Trade Name: Requlatory Class: II Product Codes: MBI and GAT Dated: May 21, 1998 Received: June 2, 1998
Dear Mr. Durlacher:
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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour 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. ਖ 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.
5
Page 2 - Mr. Scott M. Durlacher
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" (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,
S. Curtis McWhirter, Ph.D., M.
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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Image /page/6/Picture/0 description: The image shows the word "Arthrex" in bold, black letters. To the right of the word is a graphic of a surgical instrument, possibly scissors or forceps. The instrument is also in black and appears to be cutting or manipulating something.
Indications for Use
The Parachute Corkscrew Suture Anchor is intended for fixation of tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps 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: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligamant Reconstruction
Prescription Use
(Per 21 CFR 801.109)
signature
Sign-Off) (Division Pieneral Restore 510(k) Number .
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