(29 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical applications of suture anchors, with no mention of AI or ML.
Yes
The device is described as "suture or tissue fixation" which implies it is used to repair or support damaged biological structures. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as an implantable anchor used for suture or tissue fixation during surgical repair, not for diagnosing medical conditions.
No
The device description clearly states the device is comprised of physical components (titanium or PLA/ βTCP anchors) and is provided preloaded on a driver with suture. This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details physical anchors made of titanium or PLA/βTCP, preloaded with suture. This is a physical implant used in surgery.
- 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, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The Arthrex MicroSuture Anchors are intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate 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, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
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)
HWC, MAI, MBI
Device Description
The Arthrex MicroSuture Anchors consist of four anchors which are line extensions to existing anchors. The new anchors are comprised of titanium or PLA/ βTCP and are provided preloaded on a driver with suture. The anchors range from 2.2-2.7mm in diameter and 4-7mm in length.
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, 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)
The mechanical testing demonstrates that the pull-out strength of the proposed devices meets or exceeds the pull-out strength of the predicate devices.
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
§ 888.3040 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
SEP - 2 2011
Arthrex SPECIAL 510(K): Arthrex MicroSuture Anchors
2 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | August 2, 2011 |
|---|---|
| Manufacturer/Distributor | |
| /Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Manager, Regulatory Affairs | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1720 | |
| Fax: 239/598.5508 | |
| Email: courtney.smith@arthrex.com | |
| Trade Name | MicroSuture Anchors |
| Common Name | Screw, Fixation, Bone |
| Product Code - | |
| Classification Name | HWC – Screw, fixation, bone |
| MAI – Fastener, fixation, biodegradable, soft tissue | |
| MBI – Fastener, fixation, nondegradable, soft tissue | |
| 21 CFR 888.3030: Single/multiple component metallic bone | |
| fixation appliances and accessories. | |
| 21 CFR 888.3040: Smooth or threaded metallic bone fixation | |
| fastener | |
| Predicate Devices | K061863: Arthrex Corkscrew Suture Anchor |
| K063479: Arthrex Mini PushLock | |
| K091844: Arthrex Micro BioComposite Suture Tak | |
| Device Description and | |
| Intended Use | The Arthrex MicroSuture Anchors consist of four anchors |
| which are line extensions to existing anchors. The new anchors | |
| are comprised of titanium or PLA/ βTCP and are provided | |
| preloaded on a driver with suture. The anchors range from 2.2- | |
| 2.7mm in diameter and 4-7mm in length. |
The Arthrex MicroSuture Anchors are intended to be used for
suture or tissue fixation in the foot/ankle, knee, hand/wrist,
elbow, and shoulder. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial
Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion
Repair, Biceps Tenodesis, Acromio-Clavicular
Separation Repair, Deltoid Repair, Capsular Shift or
Capsulolabral 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,
Carpal Ligament Reconstruction and Carpometacarpal
joint arthroplasty (basal thumb joint arthroplasty) |
| 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 |
| Substantial Equivalence
Summary | The Arthrex MicroSuture Anchors are substantially equivalent
to the Arthrex Corkscrew, Arthrex Mini PushLock and Micro
BioComposite Suture Tak predicates, in which the basic
features, and intended uses are the same. Any differences
between the MicroSuture Anchors and the predicates are
considered minor and do not raise questions concerning safety
and effectiveness. |
| | The mechanical testing demonstrates that the pull-out strength of
the proposed devices meets or exceeds the pull-out strength of
the predicate devices. Based on the indication for use,
technological characteristics, and the comparison to the predicate
device, Arthrex, Inc. has determined that the Arthrex
MicroSuture Anchors are substantially equivalent to currently |
1/2
K川2237
1
Arthrex SPECIAL 510(k): Arthrex MicroSuture Anchors
17 - 14
KII2237
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Inc. % Ms. Courtney Smith 1370 Creekside Blvd. Naples. Florida 34108-1945
SEP - 2 2011
Re: K112237
Trade/Device Name: Arthrex MicroSuture Anchors-Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI, MBI Dated: August 2, 2011 Received: August 4, 2011
Dear Ms. Smith:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
3
Page 2 – Ms. Courtney Smith
device-related adverse events) (21 CFR 803): 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. 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/ReportalProblem/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erine D. Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form 1
Indications for Use
510(k) Number:
Device Name:
Arthrex MicroSuture Anchors
Indications For Use:
Indications for Use:
The Arthrex MicroSuture Anchors 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:
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps
Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,
Capsular Shift or Capsulolabral Reconstruction |
| Hand/Wrist: | Scapholunate 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, Carpal
Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal
thumb joint arthroplasty) |
| 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 |
Prescription Use X _ AND/OR Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
Band Tenodesis
(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
for M. Melleveron
(Division Sigh Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112237