(83 days)
Not Found
No
The summary describes a mechanical device for surgical repair and fixation, with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is intended for the repair of meniscal tears and the fixation of small bone fragments, which are therapeutic interventions aimed at restoring damaged tissue or structures.
No
This device is intended for the repair of meniscal tears and fixation of small bone fragments, which are therapeutic interventions, not diagnostic ones.
No
The device description explicitly states "The Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, and Arthrex Chondral Dart are identical to the predicate devices," and the intended use describes physical repair and fixation of tissues and bone fragments, indicating a physical medical device, not software.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that the Arthrex Meniscal Dart System and Chondral Dart are used for the repair of meniscal tears and the fixation of bone fragments. These are surgical procedures performed directly on the patient's body, not tests performed on samples outside the body.
The device is a surgical implant/device used for musculoskeletal repair.
N/A
Intended Use / Indications for Use
The Arthrex Meniscal Dart System is intended for the repair of Meniscal tears that would otherwise be considered for standard repair using suture.
The Chondral Dart is intended for the use in fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), osteochondral fragments (talus vault, femoral chondyle) and cancellous fragments (talus).
Product codes (comma separated list FDA assigned to the subject device)
HTY, MAI
Device Description
The Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, and Arthrex Chondral Dart are identical to the predicate devices. The Arthrex Meniscal Dart and Arthrex Meniscal Dartstick are intended to be use for the repair of meniscal tears. The Arthrex Chondral Dart is intended to be used for the fixation of small bone fragments. See the Indications for Use statements for specific indications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Meniscus, radial head, patellar rim, navicular, metacarpal/metatarsal, talus vault, femoral condyle, talus
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)
Not Found
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
DEC 3 0 2008
Arthrex SPECIAL 510(k): Extended Shelf Life for Meniscal and Chondral Dats
4 510(k) Summary of Safety and Effectiveness
| Manufacturer/Sponsor | Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact | Nancy Hoft
Regulatory Affairs Associate
Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA
Telephone: 239/643.5553, ext. 1113
Fax: 239/598.5508
Email: nancy.hoft@arthrex.com |
| Trade Name | Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral
Dart |
| Common Name | Pin, Dart |
| Product Code -
Classification Name | HTY-Pin, fixation, smooth MAI-Fastener, Fixation, Biodegradable, Soft Tissue |
| Predicate Devices | K983577, Arthrex Meniscal Dart System
K991971, Arthrex Chrondral Dart |
| Device Description
and Intended Use | The Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, and Arthrex
Chondral Dart are identical to the predicate devices. The Arthrex
Meniscal Dart and Arthrex Meniscal Dartstick are intended to be use
for the repair of meniscal tears. The Arthrex Chondral Dart is
intended to be used for the fixation of small bone fragments. See the
Indications for Use statements for specific indications. |
| Substantial
Equivalence
Summary | The Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, and Arthrex
Chondral Dart are identical to the predicates Arthrex Meniscal Dart
System and Arthrex Chondral Dart in which the basic features and
intended uses are the same. Any differences between the Arthrex
Meniscal Dart, Arthrex Meniscal Dartstick, and Arthrex Chondral Dart
in comparison to the cleared devices in K983577 and K991971 are
considered minor and do not raise questions concerning safety and
effectiveness. Based on the information submitted, Arthrex, Inc. has
determined that the Arthrex Meniscal Dart, Arthrex Meniscal
Dartstick, and Arthrex Chondral Dart are substantially equivalent to
the currently marketed predicate devices. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2008
Arthrex, Inc. % Ms. Nancy Hoft Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K082999 Trade/Device Names: Arthrex Menical Dart System Arthrex Chondral Dart Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI, IITY Dated: October 6, 2008 Received: October 8, 2008
Dear Ms. Hoft:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 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 that FDA has made a determination 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
2
Page 2 - Ms. Nancy Hoft
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 100-100.
This letter will allow you to begin marketing your device as described in your Section 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 this, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH)'s) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Arthrex
AND THE THE SECTION CONSULTER COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION C
Arthree SPECIAL 510(k): Extended Shelf Life for Meniscal and Chondral Darts
Indications for Use Form
Indications for Use
510(k) Number:
Device Name:
Arthrex Menical Dart System
The Arthrex Meniscal Dart System is intended for the repair of Meniscal tears that would otherwise be considered for standard repair using suture.
Prescription Use _ X _ AND/OR Over-The-Counter Use _ er 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 1
Page 7 of 133
4
Arthrex SPECIAL 510(k): Extended Shelf Life for Meniscal and Chondral DartsIndications for Use
| 510(k) Number: | K082999 |
|---|---|
| Device Name: | Arthrex Chondral Dart |
The Chondral Dart is intended for the use in fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), osteochondral fragments (talus vault, femoral chondyle) and cancellous fragments (talus).
Prescription Use __ X_ AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| PAGE 1 of 1 |
(Division Signature)
Division of General, Restorative
and Neurology Devices
| 510(k) Number | K062999 |
|---|---|
| Page 8 of 133 |