(60 days)
No
The description focuses on the material and mechanical properties of a physical screw system for soft tissue reattachment, with no mention of AI or ML capabilities.
Yes
The device is intended for the fixation of ligament and tendon graft tissue and tendon transfers in various surgeries, which are therapeutic interventions aimed at restoring function or repairing damaged tissues.
No
The device is a tenodesis screw system intended for reattachment and fixation of soft tissues and tendons. Its description and intended use indicate it is an implant for surgical repair, not for diagnostic purposes.
No
The device description explicitly states the device is a screw manufactured from PEEK, which is a physical hardware component, 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 describes a surgical implant for fixing soft tissue (ligaments and tendons) within the body. This is an in vivo application, meaning it is used within a living organism.
- Device Description: The device is a physical screw made of PEEK, designed for surgical implantation.
- 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 outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The Tenodesis Screw System is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. Specifically:
Shoulder:
- Rotator Cuff Repairs
- Bankart Repair
- 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
- Midfoot Reconstruction
- Metatarsal Ligament Repair
- Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and
- Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction.
Knee:
- Anterior Cruciate Ligament Repair
- Medial Collateral Ligament Repair
- Lateral Collateral Ligament Repair
- Patellar Tendon Repair
- Posterior Oblique Ligament Repair
- Illiotibial Band Tenodesis
Elbow: - Biceps Tendon Reattachment
- Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: - Scapholunate Ligament Reconstruction
- Ulnar Collateral Ligament Reconstruction
- Radial Collateral Ligament Reconstruction
- Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
- Carpal Ligament Reconstructions and repairs
- Ligament Reconstruction and Tendon Interposition.
Product codes
MBI
Device Description
The Tenodesis Screw System is composed of a screw manufactured from polyetheretherketone (PEEK). They are fully threaded, cannulated anchors with a flat head. The screws are provided in multiple lengths and sizes to accommodate variations in patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, elbow, knee, foot/ankle, and hand/wrist
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)
All necessary testing has been performed on representative Tenodesis Screw System components to assure substantial equivalence to its predicate and demonstrate the subject device performs as intended. All testing was performed on finished The device performance was characterized via Static Torsion, Static Insertion and Removal Torque, and Static Axial Pullout Testing per ASTM F543. Clinical data are not needed to support the safety and effectiveness of the subject devices. A Bacterial Endotoxin Test has been conducted on the subject device and it meets the specified 20 EU/Device limit. This is the recommended limit for devices that do not contact the cerebrospinal fluid.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 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.
March 1, 2019
Paragon 28, Inc. Eric Lintula Director of Regulatory Affairs 4B Inverness Court E. Suite 280 Englewood, Colorado 80112
Re: K183690
Trade/Device Name: Tenodesis Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 21, 2018 Received: December 31, 2018
Dear Mr. Lintula:
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/cdrl/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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -S
For 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K183690
Device Name Tenodesis Screw System
Indications for Use (Describe)
The Tenodesis Screw System is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. Specifically: Shoulder:
- · Rotator Cuff Repairs
- · Bankart Repair
- · 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
- Midfoot Reconstruction
- · Metatarsal Ligament Repair
- · Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and
- · Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction.
Knee:
- · Anterior Cruciate Ligament Repair
- · Medial Collateral Ligament Repair
- · Lateral Collateral Ligament Repair
- · Patellar Tendon Repair
- · Posterior Oblique Ligament Repair
- · Illiotibial Band Tenodesis
Elbow:
- · Biceps Tendon Reattachment
- · Ulnar or Radial Collateral Ligament Reconstruction Hand/Wrist:
- Scapholunate Ligament Reconstruction
- Ulnar Collateral Ligament Reconstruction
- · Radial Collateral Ligament Reconstruction
- · Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
- · Carpal Ligament Reconstructions and repairs
- · Ligament Reconstruction and Tendon Interposition.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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."
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510(k) Summary
| Date: | December 21st, 2018 |
|---|---|
| 510(k) Number: | K183690 |
| Sponsor: | Paragon 28, Inc. |
| 4B Inverness Ct. E., STE 280 | |
| Englewood, Colorado 80112 | |
| Phone: (888) 728-1888 | |
| Fax: (888) 728-1220 | |
| Sponsor contact: | Eric Lintula, Director of Regulatory Affairs |
| Trade Name: | Tenodesis Screw System |
| Regulatory Class: | Class II |
| Regulation, | |
| Product Code, | |
| Classification, and | |
| Common Name: | 888.3040, MBI, Fastener, Fixation, Nondegradable, Soft Tissue |
| Device | |
| Descriptions: | The Tenodesis Screw System is composed of a screw |
| manufactured from polyetheretherketone (PEEK). They are fully | |
| threaded, cannulated anchors with a flat head. The screws are | |
| provided in multiple lengths and sizes to accommodate | |
| variations in patient anatomy. | |
| Indications for | |
| Use: | The Tenodesis Screw System is intended for soft tissue |
| reattachment, i.e. fixation of ligament and tendon graft tissue | |
| and tendon transfers in surgeries of the shoulder, elbow, knee, | |
| foot/ankle, and hand/wrist. Specifically: | |
| Shoulder: | |
| Rotator Cuff Repairs Bankart Repair 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 Midfoot Reconstruction Metatarsal Ligament Repair Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction. | |
| • Anterior Cruciate Ligament Repair | |
| • Medial Collateral Ligament Repair | |
| • Lateral Collateral Ligament Repair | |
| • Patellar Tendon Repair | |
| • Posterior Oblique Ligament Repair | |
| • Illiotibial Band Tenodesis | |
| Elbow: | |
| • Biceps Tendon Reattachment | |
| • Ulnar or Radial Collateral Ligament Reconstruction | |
| Hand/Wrist: | |
| • Scapholunate Ligament Reconstruction | |
| • Ulnar Collateral Ligament Reconstruction | |
| • Radial Collateral Ligament Reconstruction | |
| • Carpometacarpal joint arthroplasty (basal thumb joint | |
| arthroplasty) | |
| • Carpal Ligament Reconstructions and repairs | |
| • Ligament Reconstruction and Tendon Interposition. | |
| Materials: | The Tenodesis Screw System implants are made from PEEK per |
| ASTM F2026. The instrumentation is primarily manufactured | |
| from medical grades of stainless steel. | |
| Primary | |
| Predicate: | K051726, Arthrex Tenodesis Screw Family |
| Comparison to | |
| Predicate | |
| Indications: | The subject Tenodesis Screw System and Arthrex Tenodesis |
| Screw Family devices are intended to be used for soft tissue | |
| reattachment. All indications for the subject device are within | |
| the indications of the predicate devices. | |
| Comparison to | |
| Predicate | |
| Technological | |
| Characteristics: | The subject Tenodesis Screw System components possess the |
| same technological characteristics as the respective predicate | |
| devices. These include: | |
| • performance, | |
| • basic design, | |
| • material, manufacturing and | |
| • sizes (dimensions are comparable to those offered by the | |
| predicate systems). | |
| Differences between the Tenodesis Screw System and Arthrex | |
| Tenodesis Screw Family implants were shown not to raise new | |
| questions of safety and effectiveness. Therefore, the | |
| fundamental scientific technology of the subject Tenodesis | |
| Screw System components is similar to previously cleared | |
| devices. | |
| Performance | |
| Data: | All necessary testing has been performed on representative |
| Tenodesis Screw System components to assure substantial | |
| equivalence to its predicate and demonstrate the subject device | |
| performs as intended. All testing was performed on finished | |
| The device performance was characterized via Static Torsion, | |
| Static Insertion and Removal Torque, and Static Axial Pullout | |
| Testing per ASTM F543. Clinical data are not needed to support | |
| the safety and effectiveness of the subject devices. | |
| A Bacterial Endotoxin Test has been conducted on the subject | |
| device and it meets the specified 20 EU/Device limit. This is the | |
| recommended limit for devices that do not contact the | |
| cerebrospinal fluid. | |
| Conclusion: | Performance testing demonstrates the substantial equivalence of |
| the Tenodesis Screw System to the Arthrex Tenodesis Screw | |
| Family. Therefore, the Tenodesis Screw System is substantially | |
| equivalent to the predicate devices with respect to their | |
| indications for use, technical characteristics, and function. |
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