(356 days)
No
The device description and performance studies focus on the mechanical properties and sterilization of a physical implant (suture anchors) and associated instruments. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "TopLock Anchor System" and its intended use is to "secure soft tissue to bone" for various repairs and reconstructions across multiple anatomical sites (shoulder, elbow, hand/wrist, knee, ankle/foot). This function directly contributes to treating or providing therapy for injuries or conditions.
No
The device, the TopLock Anchor System, is described as barbed suture anchors intended to secure soft tissue to bone for various repairs and reconstructions across multiple joints. Its description and intended use clearly indicate it is a surgical implant used for treatment/repair, not for diagnosing conditions.
No
The device description explicitly states it consists of "barbed suture anchors, manufactured from medical grade Polyetheretherketone or PEEK" and "specialized instruments are made primarily of surgical grade stainless steel". This indicates a physical hardware device, not software only.
No, 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, tissue) to provide information about a person's health.
- Device Description: The TopLock Anchor System is a collection of barbed suture anchors made from PEEK, intended to secure soft tissue to bone during surgical procedures. It is an implantable device used directly within the body.
- Intended Use: The intended use clearly describes surgical procedures performed on various joints of the body. This is a therapeutic and structural function, not a diagnostic one based on analyzing samples.
The information provided describes a surgical implant and its intended use in orthopedic procedures, which falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TopLock Anchor System is intended to secure soft tissue to bone of:
The Shoulder:
Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation, Rotator Cuff Repair, Capsule Repair, Biceps Tenodesis. Deltoid Repair
The Elbow:
Ulnar or Radial Collateral Ligament Reconstruction, Bicep Tendon Reconstruction, Tennis Elbow Repair
The Hand and Wrist:
Scapholunate Ligament Reconstruction, Ulnar / Radial Collateral Ligament Reconstruction, Extensor Tendon Repair, Flexor Tendon Repair
The Knee:
Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Tendon Repair
The Ankle and Foot:
Lateral Ligament Stabilization Repair, Medial Ligament Stabilization Repair.
Achilles Tendon Repair / Reconstruction, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Mid and Rear Foot Reconstruction
Product codes
MBI
Device Description
The TopLock Anchor System consists of a collection of barbed suture anchors, manufactured from medical grade Polyetheretherketone or PEEK (ASTM F2026). The anchors are offered from diameters of 3.5mm to 5.0mm with each size offering two eyelet size options to accommodate suture and suture tape. The size range and configurations are offered for surgical treatment of ligament, tendon and soft tissue pathologies of the shoulder and other joints. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Hand and Wrist, Knee, Ankle and Foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Mechanical Testing was performed to show design equivalence including insertion testing, axial pull-out testing, cyclic fatigue testing, and post fatigue pullout testing. Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay. The testing demonstrated that the subject device meets the recommended maximum endotoxin levels of 20 (EU)/Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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November 25, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Fusion Orthopedics, LLC Kolby Black 4135 S. Power Rd., Suite 110 Mesa, Arizona 85212
Re: K193377/S001
Trade/Device Name: TopLock Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: October 28, 2020 Received: October 30, 2020
Dear Mr. Black:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laura C. Rose. Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193377
Device Name TopLock Anchor System
Indications for Use (Describe)
The TopLock Anchor System is intended to secure soft tissue to bone of:
The Shoulder:
Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation, Rotator Cuff Repair, Capsule Repair, Biceps Tenodesis. Deltoid Repair
The Elbow:
Ulnar or Radial Collateral Ligament Reconstruction, Bicep Tendon Reconstruction, Tennis Elbow Repair The Hand and Wrist:
Scapholunate Ligament Reconstruction, Ulnar / Radial Collateral Ligament Reconstruction, Extensor Tendon Repair, Flexor Tendon Repair
The Knee:
Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Tendon Repair
The Ankle and Foot:
Lateral Ligament Stabilization Repair, Medial Ligament Stabilization Repair.
Achilles Tendon Repair / Reconstruction, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Mid and Rear Foot Reconstruction
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| Date Prepared | November 24, 2020 |
|---|---|
| Submitted By | Fusion Orthopedics, LLC |
| 4135 S. Power Rd., Suite 110 | |
| Mesa, AZ 85212 | |
| 800-403-6876 | |
| Primary Contact | Kolby Black |
| 4135 S. Power Rd., Suite 110 | |
| Mesa, AZ 85212 | |
| 800-403-6876 Tele | |
| e-mail: FDA@fusionorthopedics.com | |
| Trade Name | TopLock Anchor System |
| Submission | |
| Number | K193377 |
| Classification | |
| Name | Fastener, Fixation, Non-degradable, Soft Tissue |
| Class | II |
| Product Code | MBI |
| CFR Section | 21 CFR Section 888.3040 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Core Essence reNOVO Suture Anchors (K071520) |
| Secondary | |
| Predicate Device | Arthrex PEEK Mini PushLock Anchors (K101679) |
| Reference | |
| Devices | Core Essence Orthopaedics, Inc., TAC-tite™ PEEK (K111716) |
| Parcus Medical Twist & Triple Twist PEEK Screw-In Suture Anchors (K120942) | |
| Parcus Medical PEEK CF Push-In Anchors (K102162) | |
| Device | |
| Description | The TopLock Anchor System consists of a collection of barbed suture anchors, |
| manufactured from medical grade Polyetheretherketone or PEEK (ASTM F2026). The | |
| anchors are offered from diameters of 3.5mm to 5.0mm with each size offering two eyelet | |
| size options to accommodate suture and suture tape. The size range and configurations are | |
| offered for surgical treatment of ligament, tendon and soft tissue pathologies of the shoulder | |
| and other joints. The specialized instruments are made primarily of surgical grade stainless | |
| steel (ASTM F899). | |
| Indications for | |
| Use | The TopLock Anchor System is intended to secure soft tissue to bone of: |
| The Shoulder: | |
| Bankart Repair | |
| SLAP Lesion Repair | |
| Acromio-Clavicular Separation | |
| Capsule Repair | |
| Biceps Tenodesis | |
| Deltoid Repair | |
| The Elbow: | |
| Ulnar or Radial Collateral Ligament Reconstruction | |
| Bicep Tendon Reconstruction | |
| Tennis Elbow Repair | |
| The Hand and Wrist: | |
| Scapholunate Ligament Reconstruction | |
| Ulnar / Radial Collateral Ligament Reconstruction | |
| Extensor Tendon Repair | |
| Flexor Tendon Repair | |
| The Knee: | |
| Medial Collateral Ligament Repair | |
| Lateral Collateral Ligament Repair | |
| Posterior Oblique Ligament Repair | |
| Extra Capsular Reconstruction | |
| Iliotibial Band Tenodesis | |
| Patellar Tendon Repair | |
| The Ankle and Foot: | |
| Lateral Ligament Stabilization Repair | |
| Medial Ligament Stabilization Repair | |
| Achilles Tendon Repair / Reconstruction | |
| Metatarsal Ligament Repair | |
| Hallux Valgus Reconstruction | |
| Mid and Rear Foot Reconstruction | |
| Materials | Polyetheretherketone (PEEK) (ASTM F2026) |
| Ultra High Molecular Weight Polyethylene Suture (UHMWPE) (ASTM F2848) | |
| Stainless Steel (ASTM F899) | |
| Aluminum (ASTM B209) | |
| Nylon | |
| Substantial | |
| Equivalence | |
| Claimed to | |
| Predicate Devices | The TopLock Anchor System is substantially equivalent to the predicate devices in terms of |
| design, materials used, mechanical safety and performances. | |
| Non-clinical Test | |
| Summary | Validations were performed on the cleaning, packaging and sterilization of the implants and |
| associated surgical instruments. Mechanical Testing was performed to show design | |
| equivalence including insertion testing, axial pull-out testing, cyclic fatigue testing, and post | |
| fatigue pullout testing. Pyrogenicity was evaluated using the Limulus amebocyte lysate | |
| (LAL) assay. The testing demonstrated that the subject device meets the recommended | |
| maximum endotoxin levels of 20 (EU)/Device. | |
| Clinical Test | |
| Summary | No clinical studies were performed. |
| Conclusions: | |
| Non clinical and | Fusion Orthopedics LLC considers the TopLock Anchor System to be equivalent to the |
| predicate devices listed above. This conclusion is based upon the devices' similarities in |
4