(67 days)
Not Found
No
The summary describes a physical implantable device (suture anchors) made of bio-composite material. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is described as "suture or tissue fixation," which points to a surgical or orthopedic device, not one for therapy.
No
The device description and intended use indicate that the Arthrex Bio-Composite SutureTak Anchors family is for suture or tissue fixation, which is a therapeutic function, not a diagnostic one. It does not mention any diagnostic capabilities like analyzing or interpreting data to determine a medical condition.
No
The device description clearly states it is a family of "SutureTak Anchors" made with "Bio-Composite material," indicating a physical implantable device, 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 the device is for "suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder." This describes a surgical implant used in vivo (within the body) for mechanical support and repair.
- Device Description: The description talks about "smaller SutureTak models made with Bio-Composite material (PLLA or PLDLA combined with TCP)." This further reinforces that it's a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing blood, urine, tissue samples, etc.
Therefore, the Arthrex Bio-Composite SutureTak Anchors family falls under the category of a surgical implant or medical device used for fixation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex Bio-Composite SutureTak Anchors family is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Specific indications are listed below and are size appropriate per patient needs:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, Digital Tendon Transfers.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot reconstruction.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device Description
The Arthrex Bio-Composite SutureTak Anchors family is similar to the predicate devices in overall design. The difference lies in the introduction of smaller SutureTak models made with Bio-Composite material (PLLA or PLDLA combined with TCP).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, knee, hand, wrist, elbow, and 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
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
K0918YY
AUG 2 8 2009
4 .510(k) Summary of Safety and Effectiveness
| Manufacturer/Sponsor | Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945 |
|---|---|
| 510(k) Contact | Ivette Galmez |
| Regulatory Affairs Associate | |
| Telephone: 239/643.5553, ext. 1263 | |
| Fax: 239/598.5508 | |
| Email: igalmez@arthrex.com | |
| Trade Name | Arthrex Bio-Composite SutureTak Anchors |
| Common Name | Suture Anchor |
| Product Code - | |
| Classification Name | MAI - Fastener, Fixation, Biodegradable, Soft Tissue |
| HWC - Screw, Fixation, Bone | |
| Predicate Device(s) | Arthrex Bio-Composite Suture Anchors: K071177 |
| Device Description | |
| and Intended Use | The Arthrex Bio-Composite SutureTak Anchors family |
| is similar to the predicate devices in overall design. The | |
| difference lies in the introduction of smaller SutureTak models | |
| made with Bio-Composite material (PLLA or PLDLA combined | |
| with TCP). |
The Arthrex Bio-Composite SutureTak Anchors family is intended
to be used for suture or tissue fixation in the foot, ankle, knee, hand,
wrist, elbow, and shoulder. Please see indications for use form for
specific indications. |
| Substantial
Equivalence Summary | The Arthrex Bio-Composite SutureTak Anchors family is
substantially equivalent to the Arthrex Bio-Composite Suture Anchors
predicate, in which the basic features and intended uses are the
same. Any differences between the Bio-Composite SutureTak
Anchors and the predicate K071177 are considered minor and do not
raise questions concerning safety and effectiveness. Based on the
information submitted, Arthrex, Inc. has determined that the new Bio-
Composite SutureTak Anchors family is substantially equivalent to
currently marketed predicate devices. |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
g
ా
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 8 2009
Arthrex, Inc. c/o Ms. Ivette Galmez Regulatory Affairs Associate 1370 Creekside Blvd. Naples, Florida 34108-1945
Re: K091844
Trade/Device Name: Arthrex Bio-Composite SutureTak Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Smooth or threaded metallic bone fastener Regulatory Class: Class II Product Code: MAI, HWC Dated: July 29, 2009 Received: July 30, 2009
Dear Ms. Galmez:
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. Ivette Galmez
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Barbara Buchner
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number: Device Name:
691844
Device Name:
Arthrex Bio-Composite Tak
The Arthrex Bio-Composite Tak is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder: Specific indications are listed below and are size appropriate per patient needs:
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. |
|---|---|
| Shoulder: | Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, Digital Tendon Transfers. |
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot reconstruction. |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. |
Prescription Use X AND/OR Over-The-Counter Use J
(21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)
(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
Souetu for mcm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091844