(68 days)
The Headed Bio-Absorbable Corkscrew is intended for fixation of soft 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
The Headed Bio-Absorbable Corkscrew is manufactured using poly (L, DL-lactide). It is a threaded design with a rounded head which is slotted to accept the associated driver. Prior to driving in the anchor, it is necessary to prepare the bone using a tap.
The provided text describes a 510(k) premarket notification for the Arthrex Headed Bio-Absorbable Corkscrew. This document primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not present in the provided text. The information is organized below based on what is available.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the Arthrex Headed Bio-Absorbable Corkscrew in the traditional sense of pre-defined thresholds for performance. Instead, it relies on a comparison to predicate devices, demonstrating that its performance is comparable to or better than previously cleared devices.
The key performance metric presented is Pull-Out Strength. The comparison to predicate devices serves as the de-facto "acceptance criteria" by demonstrating substantial equivalence.
| Performance Characteristic | Arthrex Headed Bio-Absorbable Corkscrew Reported Performance | Predicate Device (Arthrex FASTak) Reported Performance | Predicate Device (Zimmer Bio-Statak (RSTA)) Reported Performance | Predicate Device (Linvatec Bio-Anchor) Reported Performance |
|---|---|---|---|---|
| Pull-Out Strength | 79.3 lbs.* | 55.40 lbs.* | Diaphyseal: 69 lbs. ** Metaphyseal: 71 lbs. Cancellous: 70 lbs. | Diaphyseal: 33 lbs. ** Metaphyseal: 49 lbs. Cancellous: 29 lbs. |
| Material | Poly (L, DL-lactide) | Titanium Alloy | Poly (L-lactic) acid | Poly (L-lactic) acid |
| Size | 5.0mm | 2.4mm / #2 suture | 5.0mm / #2 suture | 3.5mm / #0 to #2 suture |
| Insertion Method | Screw in | Screw in | Screw in | Impact |
| Intended Use | Soft tissue to bone fixation | Soft tissue to bone fixation | Soft tissue to bone fixation | Soft tissue to bone fixation |
Note: Pull-out testing performed using a 20 lb. density foam block to simulate poor quality bone.
*Note: Data from "Suture Anchors Product Information Guide" – Orthopedic Special Edition: Winter/Spring 1997.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The pull-out strength value of 79.3 lbs likely represents an average or a specific measurement from a set of tests, but the number of samples tested is not provided in this summary.
- Data Provenance: The pull-out testing for the Arthrex Headed Bio-Absorbable Corkscrew was performed in a controlled laboratory setting (simulated poor quality bone using a 20 lb. density foam block). This would be considered an in-vitro (or benchtop) study, rather than retrospective or prospective patient data. The country of origin for this specific test is not mentioned, but the company is based in Naples, Florida, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes mechanical testing of a medical device (pull-out strength), not a diagnostic device involving expert interpretation or "ground truth" in the clinical sense.
4. Adjudication method for the test set
Not applicable. This concerns mechanical testing; there is no adjudication process in the context of expert review.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a mechanical fixation device, not a diagnostic imaging device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a mechanical fixation device.
7. The type of ground truth used
For the pull-out strength, the "ground truth" is typically the direct measurement from the mechanical testing equipment (e.g., a universal testing machine). This is objective, quantitative data.
8. The sample size for the training set
Not applicable. This is a mechanical device; there is no "training set" in the context of machine learning or algorithms. The design and material choices are based on engineering principles and prior art, as well as testing of the chosen material (poly(L,DL-lactide)) by Synthes and an independent evaluation by Claes et al.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of this device. The selection of materials and design features would be based on established engineering principles, material science, and previous regulatory clearances for similar materials (e.g., Poly (L,DL-lactide) in the Synthes Polypin). The "ground truth" for material properties would come from in-vitro and in-vivo testing, as mentioned for the Synthes material and the study by Claes et al.
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APR 1 4 1999
510(k) Summary
02/01/99
| Company: | Arthrex, Inc. |
|---|---|
| Address: | 2885 S. Horseshoe Drive, Naples, FL 34104- |
| Phone: | (941) 643-5553 |
| Fax: | (941) 643-6218 |
| Contact: | Vernon C. BrownManager Regulatory Affairs (ext. 117) |
| Trade Name: | Arthrex Headed Bio-Absorbable Corkscrew |
|---|---|
| Common Name: | Bio-Absorbable Corkscrew Fastener |
| Classification: | Fastener, Fixation, Biodegradable, Soft Tissue |
Description:
The Headed Bio-Absorbable Corkscrew is manufactured using poly (L, DL-lactide). It is a threaded design with a rounded head which is slotted to accept the associated driver. Prior to driving in the anchor, it is necessary to prepare the bone using a tap.
Intended Use:
The Headed Bio-Absorbable Corkscrew is intended for fixation of soft 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 Ligamant Reconstruction
Substantial Equivalence:
Substantial equivalence is substantiated when 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
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(121)
from the predicate device.
A substantial equivalence comparison is given in Table A.
In regards to the material. Poly (L.DL-Lactide), it is currently used in the Synthes Polypin which recently received FDA marketing clearance. This material has undergone extensive in-vitro and in-vivo testing by Synthes.
In addition to the testing performed by Synthes, an independent evaluation of the material was conducted by Claes et. al. ("New bioresorbable pin for the reduction of small bony fragments: design, mechanical properties and in vitro degradation" - Biomaterials, 1996, Vol. 17 No. 16).
None of the aforementioned differences make the Arthrex Headed Bio-Absorbable Corkscrew 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.
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| Company | Device | Intended Use | Material | Size(s) | Insertion | Pull-Out |
|---|---|---|---|---|---|---|
| Arthrex | Headed Bio-AbsorbableCorkscrew | Soft tissue to bonefixation | Poly (L, DL-lactide) | 5.0mm | Screw in | 79.3 lbs.* |
| Arthrex | FASTak | Soft tissue to bonefixation | Titanium Alloy | 2.4mm#2 suture | Screw in | 55.40 lbs.*As reported: K971723 |
| Zimmer | Bio-Statak(RSTA) | Soft tissue to bonefixation | Poly (L-lactic) acid | 5.0mm#2 suture | Screw in | Diaphyseal: 69 lbs. **Metaphyseal: 71 lbs.Cancellous: 70 lbs. |
| Linvatec | Bio-Anchor | Soft tissue to bonefixation | Poly (L-lactic) acid | 3.5mm#0 to #2 suture | Impact | Diaphyseal: 33 lbs. **Metaphyseal: 49 lbs.Cancellous: 29 lbs. |
| Ethicon | Mitek 3.5mmPanalok WedgeAbsorbableSuture Anchor | Soft tissue to bonefixation. | Poly (L(-)-lactide)polymer | 3.5mm | In tunnelfixation | Unknown |
Table A: Substantial Equivalence Comparison
- Pull-out testing performed using a 20 lb. density foam block to simulate poor quality bone
ર્દ્ર
** "Suture Anchors Product Information Guide" – Orthopedic Special Edition: Winter/Spring 1997
990361
38f3
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 14 1999
Mr. Vernon C. Brown Requlatory Affairs Manager Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re: K990361 Headed Bio-Absorbable Corkscrew Trade Name: Regulatory Class: II Product Codes: MAI and HWC Dated: February 3, 1999 February 5, 1999 Received:
Dear Mr. Brown:
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 aqainst 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 Regulation (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 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.
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Page 2 - Mr. Vernon C. Brown
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,
Calia M. Whitten, 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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Indications for Use
: :
The Headed Bio-Absorbable Corkscrew is intended for fixation of soft 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
(Divisi
Divis 510k; Number
Prescription Use
X
(Per 21 CFR 801.109)
§ 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.