(216 days)
The Tenodesis screws are intended for soft tissue reattachment procedures in foot surgery.
The system is indicated for soft tissue reattachment procedures in foot surgery, such as tendon reconstructions and tendon transfers.
The system can be used in adult patients. Additional information is provided in the corresponding surgical techniques.
The Tenodesis screw system is intended for soft tissue reattachment procedures in foot surgery. The screws are made of titanium alloy Ti-6AI-4V (ASTM F136). They are threaded, fully cannulated anchors.
The implants are offered in various sizes. The implants are provided non-sterile and single-use only.
The Tenodesis instruments are non-sterile and reusable.
Based on the provided text, the device in question is a "Tenodesis screw system." This document is a 510(k) submission, which focuses on demonstrating substantial equivalence to pre-existing predicate devices rather than proving performance against specific acceptance criteria in a traditional clinical study format for a novel device. Therefore, many of the requested categories for a study proving acceptance criteria will not be directly applicable or available in this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, formal "acceptance criteria" for a novel device performance study are not explicitly stated. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through mechanical testing and biocompatibility.
| Acceptance Criteria Category | Reference/Method | Reported Device Performance |
|---|---|---|
| Intended Use | Comparison to predicate devices (G-Force Tenodesis Screw, Arthrex Tenodesis Screw Family, Arthrex Resorbable Interference Screw) | The Tenodesis screw system has the same intended use for soft tissue reattachment procedures in foot surgery (tendon reconstructions and tendon transfers in adult patients). |
| Technological Characteristics | Comparison to predicate devices regarding design, components, materials, and principles of operation. | The system has similar performance characteristics, is manufactured from similar materials (titanium alloy Ti-6AI-4V), and is similar in design to the selected predicate devices. |
| Biocompatibility | ISO 10993-1 | Biocompatibility testing on the plates was conducted and evaluated per ISO 10993-1. All testing passed. |
| Mechanical Properties | Self-tapping performance, driving, torsional properties, and axial pullout strength tests. (Implied comparison to predicate devices, though specific benchmarks are not provided). | Self-tapping performance, driving, torsional properties, and axial pullout strength of the Tenodesis screw system and the predicate devices resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for the mechanical and biocompatibility tests. It states that "Biocompatibility testing on the plates was conducted and evaluated per ISO 10993-1" and "Self-tapping performance, driving, torsional properties and axial pullout strength of the Tenodesis screw system and the predicate devices resulted in similar mechanical properties and performance." The data provenance is from the manufacturer's internal testing as part of the 510(k) submission. No information on country of origin of data or retrospective/prospective status is available for these non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The evaluations (biocompatibility and mechanical properties) rely on established international standards (ISO 10993-1) and direct physical measurements, not expert interpretation of data points that require a "ground truth" established by human experts in the sense of a clinical trial.
4. Adjudication method for the test set
Not applicable, as this is not a human-adjudicated clinical study. The evaluations are based on objective test results against established mechanical and biological performance parameters.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (screw system), not an AI diagnostic or assistance tool. Therefore, an MRMC study and AI improvement metrics are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For biocompatibility, the ground truth is compliance with the requirements of ISO 10993-1. For mechanical properties, the "ground truth" is measured physical properties that are comparable to those of the predicate devices, implying that the established performance of the predicate serves as the benchmark. No clinical "ground truth" (pathology, outcomes data) was used or required for this 510(k) submission.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Normed Medizin-Technik GmbH Mr. Arne Briest RA/QA Manager Ulrichstrasse 7 Tuttlingen, D-78532 Germany
January 26, 2016
Re: K151701
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: HWC, MBI Dated: December 23, 2015 Received: December 28, 2015
Dear Mr. Arne Briest:
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
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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 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 Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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) K151701
Device Name Tenodesis screw system
Indications for Use (Describe)
The Tenodesis screws are intended for soft tissue reattachment procedures in foot surgery.
The system is indicated for soft tissue reattachment procedures in foot surgery, such as tendon reconstructions and tendon transfers.
The system can be used in adult patients. Additional information is provided in the corresponding surgical techniques.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
Page 1 of 1
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Image /page/3/Picture/2 description: The image shows the logo for NORMED, a Zimmer company. The logo is black and white and features the word "NORMED" in a bold, sans-serif font. The "O" in NORMED is replaced by a globe. Below the word "NORMED" is the text "A ZIMMER COMPANY" in a smaller, sans-serif font.
510(k) Summary
1. Submission Sponsor and Correspondent
Normed Medizin-Technik GmbH Ulrichstrasse 7 D-78532 Tuttlingen Germany
| Phone: | + 49 7461 93 43 0 |
|---|---|
| Fax: | + 49 7461 93 43 20 |
| Contact: | Mr. Arne Briest |
| FDA Establishment Registration #: | 9611091 |
2. Date Prepared
January 26, 2016
3. Device Identification
| Trade/Proprietary Name: | Tenodesis screw system |
|---|---|
| Common/Usual Name: | Screw (smooth or threaded metallic bone fixation fastener) |
| Classification Name: | Screw, Fixation, Bone andFastener, Fixation, Non degradable, Soft Tissue |
| Classification Regulation: | 21CFR 888.3040 |
| Product Code: | HWC/MBI |
| Device Class: | Class II |
| Classification Panel: | Orthopedic |
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Image /page/4/Picture/2 description: The image shows the logo for Normed, a Zimmer company. The logo is black and white and features the word "NORMED" in large, bold letters. Above the word "NORMED" is the text "The specialist for small bones". Below the word "NORMED" is the text "A ZIMMER COMPANY".
4. Legally Marketed Predicate Device
K143165 - Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw
K061211 - NCB Cannulated Screw
K083150 - G-Force Tenodesis Screw
K051726 - Arthrex Tenodesis Screw Family
K041274 - Arthrex Resorbable Interference Screw (Rattler Interference Screw)
5. Device Description
The Tenodesis screw system is intended for soft tissue reattachment procedures in foot surgery. The screws are made of titanium alloy Ti-6AI-4V (ASTM F136). They are threaded, fully cannulated anchors.
The implants are offered in various sizes. The implants are provided non-sterile and single-use only.
The Tenodesis instruments are non-sterile and reusable.
6. Indications for Use
The Tenodesis screws are intended for soft tissue reattachment procedures in foot surgery.
The system is indicated for soft tissue reattachment procedures in foot surgery, such as tendon reconstructions and tendon transfers.
The system can be used in adult patients. Additional information is provided in the corresponding surgical techniques.
7. Substantial Equivalence Discussion
The Tenodesis screw system has the same intended use as the G-Force Tenodesis Screw, the Arthrex Tenodesis Screw Family and the Arthrex Resorbable Interference Screw. The Tenodesis screw system has similar performance characteristics, is manufactured from similar materials and is similar in design to the all selected predicate devices.
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Image /page/5/Picture/2 description: The image shows the logo for NORMED, a Zimmer company. The logo is black and white and features the word "NORMED" in large, bold letters. The "O" in NORMED contains a graphic of the earth with lines of longitude and latitude. Below the word "NORMED" is the text "A ZIMMER COMPANY" in a smaller font.
8. Non-Clinical Performance Data
- -Biocompatibility - Biocompatibility testing on the plates was conducted and evaluated per ISO 10993-1. All testing passed.
- -Self-tapping performance, driving, torsional properties and axial pullout strength of the Tenodesis screw system and the predicate devices resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.
9. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device.
10. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device has the same intended use (G-Force Tenodesis Screw, Arthrex Tenodesis Screw Family and the Arthrex Resorbable Interference Screw) and the same technological characteristics (all selected predicates) as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the difference between the Tenodesis screws and the predicate devices do not raise any questions regarding its safety and effectiveness.
Performance testing and compliance with voluntary standards, demonstrate that the Tenodesis screw system is substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use (G-Force Tenodesis Screw, Arthrex Tenodesis Screw Family and the Arthrex Resorbable Interference Screw).
The Tenodesis screw system is determined to be substantially equivalent to the referenced predicate devices.
§ 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.