(81 days)
No
The summary describes a mechanical suture anchor and associated tape, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for the reattachment of soft tissue to bone for various indications, such as rotator cuff repair and ligament repair, which are therapeutic interventions.
No
The LigaMetrics Suture Anchors are described as implants "designed to secure soft tissue to bone" for reattachment in various anatomical sites. Their function is to provide fixation, not to diagnose a condition.
No
The device description clearly states it is a physical implant (suture anchors) and includes performance testing for physical properties like insertion and pullout strength.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for the reattachment of soft tissue to bone. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (suture anchor) designed to be placed within the body.
- 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) to provide information for diagnosis, monitoring, or screening.
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 LigaMetrics Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.
Scapholunate ligament reconstruction, Hand/Wrist: Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
Hip: Distal row abductor tendon repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The LigaMetrics Suture Anchors are offered in Threaded and Push-In versions and are designed to secure soft tissue to bone. The implant is marketed with previously cleared ultra-high molecular weight polyethylene (UHMWPE) 2.0mm OrthoTape® (K150438) which is provided sterile packaged from Teleflex, Inc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Hand/Wrist, Elbow, 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)
Nonclinical Testing:
All necessary testing has been performed for the worst-case LigaMetrics Suture Anchors to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of finished devices. The performance of the LigaMetrics Suture Anchors was characterized through the following tests:
- Insertion Testing ●
- Pullout Strength Testing
- Static Interconnection Strength Testing ●
- Fatigue Testing
Clinical data were not needed to support the safety and effectiveness of the subject device.
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.
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2017
Mortise Medical LLC Mr. Robert Hov Director of Research 124 South 600 West. Suite 100 Logan, Utah 84321
Re: K171964
Trade/Device Name: LigaMetrics Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 29, 2017 Received: June 30, 2017
Dear Mr. Hoy:
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 device
1
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 contact the Division of Industry and Consumer Education (DICE) 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 (DICE) 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171964
Device Name LigaMetrics Suture Anchors
Indications for Use (Describe)
The LigaMetrics Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
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 collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
Hip: Distal row abductor tendon 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) |
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510(k) Summary
| Device Trade Name: | LigaMetrics Suture Anchors |
|---|---|
| Manufacturer: | Mortise Medical LLC |
| 124 South 600 West, Suite 100 | |
| Logan, UT 84321 | |
| Contact: | Mr. Robert Hoy |
| Director of Research | |
| Phone: (614) 448-6358 | |
| Fax: (435) 213-4878 | |
| bob@surgicalfrontiers.com | |
| Date Prepared: | June 29, 2017 |
| Common Name: | Smooth or threaded metallic bone fixation fastener |
| Classification: | 21 CFR 888.3040 |
| Class: | II |
| Product Code: | MBI |
Indications for Use:
The LigaMetrics Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.
Scapholunate ligament reconstruction, Hand/Wrist: Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
Hip: Distal row abductor tendon repair.
4
Device Description:
The LigaMetrics Suture Anchors are offered in Threaded and Push-In versions and are designed to secure soft tissue to bone. The implant is marketed with previously cleared ultra-high molecular weight polyethylene (UHMWPE) 2.0mm OrthoTape® (K150438) which is provided sterile packaged from Teleflex, Inc.
Predicate Devices:
The Smith & Nephew, Inc. Footprint Ultra PK Suture Anchor (K093897, K113274, K123579) serves as the primary predicate, and the MTP Solutions LLC Titanium Suture Anchor (K133229) serves as a reference predicate device.
Technological Characteristics Comparison:
The LigaMetrics Suture Anchors and the predicates are similar in design, function, material, size and performance. Each subject and predicate device is designed to reattach soft tissue to bone. Further, the subject devices and Footprint Ultra PK Suture Anchor predicate device are designed to allow for anchor placement and independent suture tensioning and locking. The LigaMetrics Suture Anchor subject device implants and the Titanium Suture Anchor predicate device implants are manufactured from Ti-6Al-4V ELI (ASTM F136), a material with well-established biocompatibility and a long history of use in many previously cleared permanent implants. In addition, the subject and both predicate devices are for use with UHMWPE suture material.
Side-by-side mechanical performance testing demonstrates that the design differences between the LigaMetrics Suture Anchor subject devices and the Footprint Ultra PK Suture Anchor predicate device introduce no new issues of safety or effectiveness.
Nonclinical Testing:
All necessary testing has been performed for the worst-case LigaMetrics Suture Anchors to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of finished devices. The performance of the LigaMetrics Suture Anchors was characterized through the following tests:
- Insertion Testing ●
- Pullout Strength Testing
- Static Interconnection Strength Testing ●
- Fatigue Testing
Clinical data were not needed to support the safety and effectiveness of the subject device.
Substantial Equivalence:
The Mortise Medical LLC LigaMetrics Suture Anchors are substantially equivalent to Smith & Nephew, Inc. Footprint Ultra PK Suture Anchor (K093897, K113274, K123579) and the MTP Solutions LLC Titanium Suture Anchor (K133229) with respect to their indications for use, design, material, size, performance and function.