(161 days)
Not Found
No
The summary describes mechanical suture anchors made of PEEK with preloaded suture. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on mechanical properties like pull-out strength.
No
The device is described as anchors used for suture or tissue fixation in orthopedic procedures, which are surgical tools or implants, not devices used to deliver therapy.
No
Explanation: The device, Arthrex SwiveLock Anchors, is described as intended for suture or tissue fixation in orthopedic procedures (e.g., Rotator Cuff Repair, Bankart Repair, Ligament Reconstruction). Its function is to secure sutures or tissues to bone, which is a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states the anchors are composed of Polyetheretherketone (PEEK) and are preloaded on a driver, indicating a physical hardware component.
Based on the provided text, this 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 these are suture anchors made of PEEK, intended for suture or tissue fixation in various anatomical locations (foot/ankle, knee, hand/wrist, elbow, shoulder, hip). This is a surgical implant used directly in the body for mechanical support.
- Lack of mention of biological samples or testing: The text does not mention any analysis of biological samples or diagnostic testing.
Therefore, the Arthrex MicroSuture Anchors and SwiveLock Anchors are medical devices used for surgical repair, not in vitro diagnostics.
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 for use 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 of Collateral Ligaments, Repair of Flexor and Extensor Tendous 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
The Arthrex SwiveLock Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
Shoulder: Rotator Cuff Repairs, Bankart 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique, Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Arthrex DX SwiveLock SL with Forked Eyelet, 3.5 x 8.5mm and Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm share the same design features, materials, and intended use as the predicates. The anchors are composed of Polyetheretherketone (PEEK) and are preloaded on a driver with nonabsorbable suture. The anchors are provided in a 3.5mm diameter and feature lengths of 8.5 and 13.5mm, respectively.
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, hip
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 submitted mechanical testing data demonstrates that the pull-out strength and torque to failure of the proposed devices meets or exceeds that of the predicate devices for the desired indications.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2015
Arthrex, Incorporated Ms. Laura Medlin Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K150648
Trade/Device Name: Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: March 9, 2015 Received: March 12, 2015
Dear Ms. Medlin:
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 of medical device-related
1
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150648
Device Name
Arthrex DX SwiveLock SL with Forked Eyelet 3.5 x 8.5mm
Indications for Use (Describe)
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 for use 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 of Collateral Ligaments, Repair of Flexor and Extensor Tendous 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150648
Device Name
Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm
Indications for Use (Describe)
The Arthrex SwiveLock Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
Shoulder: Rotator Cuff Repairs, Bankart 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique, Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
2.5 510K SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | August 10, 2015 |
|---|---|
| Manufacturer/ | |
| Distributor/ | |
| Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Laura Medlin |
| Regulatory Affairs | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 72005 | |
| Fax: 239/598.5508 | |
| Email: laura.medlin@arthrex.com | |
| Trade Name | Arthrex DX SwiveLock SL with Forked Eyelet, 3.5 x 8.5mm |
| Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm | |
| Common Name | Suture Anchor |
| Product Code, | |
| Classification Name, CFR | MBI |
| 21 CFR 888.3030: Smooth or threaded metallic bone fixation fastener | |
| Predicate Device | K101823: Arthrex SwiveLock Anchors |
| K112237: Arthrex MicroSuture Anchors | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex DX SwiveLock SL with Forked Eyelet, 3.5 x 8.5mm and Arthrex DX | |
| SwiveLock Suture Anchor, 3.5 x 13.5mm. This bundled submission has been | |
| converted from a Special to Traditional 510(k) premarket notification as Arthrex | |
| has chosen to establish substantial equivalence by means of two predicate devices | |
| previously cleared under the auspices of K101823 and K112237, respectively. | |
| Device Description | The Arthrex DX SwiveLock SL with Forked Eyelet, 3.5 x 8.5mm and Arthrex DX |
| SwiveLock Suture Anchor, 3.5 x 13.5mm share the same design features, | |
| materials, and intended use as the predicates. The anchors are composed of | |
| Polyetheretherketone (PEEK) and are preloaded on a driver with nonabsorbable | |
| suture. The anchors are provided in a 3.5mm diameter and feature lengths of 8.5 | |
| and 13.5mm, respectively. | |
| Intended Use | The Arthrex DX SwiveLock SL with Forked Eyelet, 3.5 x 8.5mm is intended to be |
| used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and | |
| shoulder. Specific indications for use 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-Clabicular Separation Repair, Deltoid Repair, Capsular Shift | |
| or Capsulolabral Reconstruction | |
| Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of | |
| Collateral Ligaments, Repair of Flexor and Extensor Tendous 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 | |
| The Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm is intended for fixation of | |
| suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, | |
| and hip in the following procedures: | |
| Shoulder: Rotator Cuff Repairs, Bankart Repairs, 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, Mid-foot Reconstruction, Metatarsal Ligament | |
| Repair/Tendon Repair, Bunionectomy | |
| 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 or Radial Collateral | |
| Ligament Reconstruction, Radial Collateral Ligament Reconstruction | |
| Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial | |
| Collateral Ligament Reconstruction, Lateral Epicondylitis Repair | |
| Hip: Capsular repair, Acetabular Labral repair | |
| Substantial | |
| Equivalence Summary | The Arthrex DX SwiveLock SL with Forked Eyelet, 3.5 x 8.5mm and Arthrex DX |
| SwiveLock Suture Anchor, 3.5 x 13.5mm are substantially equivalent to the | |
| predicate devices, in which the basic design features and intended uses are the | |
| same. | |
| The predicate Arthrex MicroSuture Anchors (K112237) are composed of titanium | |
| or PLDLA/BTCP and are provided pre-loaded on a driver with suture. The | |
| predicate anchors range from 2.2 – 2.7mm in diameter and 4.0 - 7.0mm in length. | |
| The predicate Arthrex SwiveLock Anchors (K101823) bodies are fully threaded, | |
| fully cannulated and may be vented or non-vented. The SwiveLock Anchor eyelet | |
| may feature an open or closed design. SwiveLock components, anchor bodies and | |
| eyelets are manufactured from various materials and are sold in different | |
| component/material combinations. The predicate devices are provided pre- | |
| mounted on a driver with the anchor body and eyelet physically separated on a | |
| driver shaft. FiberWire® Suture may also be packaged with the sterile Arthrex | |
| SwiveLock Anchors. | |
| Similar to the predicate product offering, the devices subject of this 510(k) | |
| premarket notification are featured in a 3.5mm diameter and lengths of 8.5 and | |
| 13.5mm, respectively. Identical to the predicate anchors, the Arthrex DX | |
| SwiveLock SL with Forked Eyelet, 3.5 x 8.5mm and Arthrex DX SwiveLock Suture | |
| Anchor, 3.5 x 13.5mm are manufactured from Polyethertherketone (PEEK), may | |
| be provided vented or non-vented, and feature and open or closed eyelet design. | |
| The Arthrex DX SwiveLock SL with Forked Eyelet, 3.5 x 8.5mm and Arthrex DX | |
| SwiveLock Suture Anchor, 3.5 x 13.5mm are pre-mounted on a driver with the | |
| anchor body and eyelet physically separated on a driver shaft. The product is | |
| packaged sterile with FiberWire™ Suture. Any differences between the Arthrex | |
| DX SwiveLock SL with Forked Eyelet, 3.5 x 8.5mm and Arthrex DX SwiveLock | |
| Suture Anchor, 3.5 x 13.5mm and the predicates are considered minor and do not | |
| raise questions concerning safety and effectiveness. | |
| The submitted mechanical testing data demonstrates that the pull-out strength | |
| and torque to failure of the proposed devices meets or exceeds that of the | |
| predicate devices for the desired indications. | |
| Based on the indications for use, technological characteristics, and the summary | |
| of data submitted, Arthrex, Inc. has determined that the Arthrex DX SwiveLock SL |
5
6
| with Forked Eyelet, 3.5 x 8.5mm and Arthrex DX SwiveLock Suture Anchor, 3.5 x |
|---|
| 13.5mm are substantially equivalent to currently marketed predicate devices. |