(89 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and bio-resorbable materials of a surgical implant, with no mention of AI or ML.
Yes
The device is a medical implant used to repair meniscal tears, which fits the definition of a therapeutic device.
No
The document describes a device "indicated for the repair of vertical longitudinal full thickness tears" and mentions "mechanical testing found the device to be substantially equivalent in pullout strength." This language clearly indicates a therapeutic or repair device, not one used for diagnosis.
No
The device description clearly states it incorporates physical components (toggle anchors, suture loops) made of a bio-resorbable copolymer, indicating it is a hardware device, not software-only.
Based on the provided information, the Arthrotek® Meniscal Hybrid Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the device is a surgical implant used for the repair of meniscal tears. It is a physical device implanted into the body to treat a condition, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting biomarkers or analytes.
- Providing diagnostic information.
- Using reagents or assays.
Therefore, the Arthrotek® Meniscal Hybrid Device is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrotek® Meniscal Hybrid Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
Product codes (comma separated list FDA assigned to the subject device)
JDR, MAI
Device Description
The Arthrotek® Meniscal Hybrid Device incorporates two toggle anchors attached by two suture loops, one suture loop containing a sliding knot. The toggle anchors are approximately 7mm long and have beveled tips on each end. Incorporated into the body of the toggle anchor is an eyelet for the suture to pass through. They are constructed of Lactosorby, a bio-resorbable copolyment of PLLA/PGA
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
meniscus
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)
Non-Clinical Testing: Mechanical testing found the Arthrotek® Meniscal Hybrid Device to be substantially equivalent in pullout strength, to the predicate Meniscal Repair Device (K982095).
Clinical Testing: Clinical testing was not required for these components to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 888.3030 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.
0
K041988 pg 192
OCT 2 0 2004
510(k) Summary
| Applicant/Sponsor: | Arthrotek. Inc.
(A wholly owned subsidiary of Biomet, Inc.)
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Baker
Biomet Manufacturing Corp.
P.O. Box 587
Warsaw, Indiana 46581-0587
Phone: (574) 267-6639 |
| Proprietary Name: | Arthrotek® Meniscal Hybrid Device |
| Common Name: | Meniscal Repair Device |
| Classification Name: | Fastener, Fixation, Biodegradable, Soft Tissue 21 CFR §888.3045 |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
- K982095 Lactosorb® Meniscal Repair Device Biomet Inc., Warsaw, IN *
- K965228 Surgical Dynamics Meniscal Staple U.S. Surgical, Norwalk, CT *
Device Description:
The Arthrotek® Meniscal Hybrid Device incorporates two toggle anchors attached by two suture loops, one suture loop containing a sliding knot. The toggle anchors are approximately 7mm long and have beveled tips on each end. Incorporated into the body of the toggle anchor is an eyelet for the suture to pass through. They are constructed of Lactosorby, a bio-resorbable copolyment of PLLA/PGA
Intended Use:
The Arthrotek® Meniscal Hybrid Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
1
Summary of Technologies:
Summal your receintered. Lactosorb® PLLA/PGA copolymer as the predicate Meniscal Repair Device (K982095).
Non-Clinical Testing:
Mechanical testing found the Arthrotek® Meniscal Hybrid Device to be substantially equivalent in pullout strength, to the predicate Meniscal Repair Device (K982095).
Clinical Testing:
Clinical testing was not required for these components to support substantial equivalence.
All trademarks are property of Biomet, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2004
Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581
Re: K041988
Trade/Device Name: Arthrotek® Meniscal Hybrid Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, MAI Dated: July 22, 2004 Received: July 23, 2004
Dear Mr. Baker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became innd the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease in the enactment date of the Medical Device Amendments, or to conimered pror to may 20, 2011 accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic (110) that be device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general controll profiter practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elabilitional controls. Existing major regulations affecting your device can may or babyer to been to begulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease be actived that i Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Gary Baker
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I ms letter will anow you to begin maneting your and equivalence of your device to a legally prematket notification. The PDA mining of basification 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 Patt 801), please if you desire specific advice for your do the research and the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Misorallumg Oy Telefono to premainsmonsibilities under the Act may be obtained from the Other general information on your responsible and Consumer 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,
Mark A. Millburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
INDICATIONS FOR USE
510(k) Number (if known): K041958
Device Name: Arthrotek® Meniscal Hybrid Device
Indications For Use:
The Arthrotek® Meniscal Hybrid Device is indicated for the repair of vertical longitudinal full The Arthrotek® Meniscal Hybrid Device is the red-white zones. These devices are not to
thickness tears (i.e. bucket-handle) in the red-red-white somes. These devices are not unckliess toars (no. I tears in the avascular zone of the meniscus.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ 1/0 (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K041988 |