(48 days)
The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System.
The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
- avascular necrosis of femoral condyle
- post traumatic loss of joint configuration
- primary implantation failure.
The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System. The Medacta Bone Screws have a thread diameter of 6.5 mm. The Medacta Bone Screws come in six lengths from 20 mm to 45 mm in increments of 5 mm. The Medacta Bone Screws are made of titanium alloy (Ti6-Al4-V) according to ISO5832-3:1996, Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4-vanadium alloy.
The provided K091069 510(k) summary describes a traditional 510(k) submission for the Medacta Bone Screws. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through material, design, and performance testing against recognized standards, rather than a clinical study evaluating diagnostic performance using AI.
Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Guideline) | Reported Device Performance |
|---|---|
| ASTM F543-07 Standard Specification and Test Methods for Metallic Bone Screws | The bone screws were tested and found to be in conformance with ASTM F543-07. |
| ISO 5832-3:1996, Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4-vanadium alloy | The Medacta Bone Screws are made of titanium alloy (Ti6-Al4-V) according to this standard. |
| FDA Guidance Documents | Performance testing was conducted in accordance with FDA guidance documents. (Specific documents not listed, but conformance is stated). |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "Performance testing," which was conducted in accordance with ASTM F543-07 and FDA guidance documents. This testing demonstrated conformance to these standards.
Information on AI-Related Aspects (Not Applicable to this 510(k)):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This was not an AI-based diagnostic device. The "test set" would refer to the physical bone screws tested per ASTM F543-07, not a dataset.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. There was no "ground truth" in the clinical sense for this type of device submission. Performance was based on mechanical testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for bone screws is their mechanical properties meeting established engineering standards.
- The sample size for the training set: Not applicable. This was not an AI device, so there was no training set.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of a stylized black triangle on the left, followed by the word "Medacta" in black sans-serif font. Below the word is a horizontal line, and below that is the word "International" in a smaller font, followed by a plus sign.
JUN - 1 2009
Traditional 510(k) Summary
Manufacturer:
MEDACTA International SA Strada Regina CH6874 Castel San Pietro Switzerland Phone (+41) 91 696 60 60 FAX (+41) 91 696 60 66
Contact Person:
Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: (858) 705-0350 Fax: (858) 764-9739 email: NKennel@njkconsulting.com
May 27, 2009 Date Prepared:
DEVICE INFORMATION
| Trade/Proprietary Name: | Medacta Bone Screws |
|---|---|
| Common Name: | Bone Screws |
| Classification Name: | Screw, Fixation, Bone21 CFR 888.3560Class IIDevice Product Code: JWH |
| Predicate Devices: | K011719 Plus Cancellous Bone ScrewsK081023 Evolis Total Knee System |
Product Description:
The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System. The Medacta Bone Screws have a thread diameter of 6.5 mm. The Medacta Bone Screws come in six lengths from 20 mm to 45 mm in increments of 5 mm.
Page 1 of 2
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The Medacta Bone Screws are made of titanium alloy (Ti6-Al4-V) according to ISO5832-3:1996, Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4-vanadium alloy.
Indications for Use:
The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System.
The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic . arthritis, rheumatoid arthritis or polyarthritis
- avascular necrosis of femoral condyle .
- post traumatic loss of joint configuration ●
- primary implantation failure. �
Performance Testing
No performance standards applicable to this device have been adopted under Section 514 of the Food, Druq and Cosmetic Act. Performance testing of the Medacta Bone Screws was conducted in accordance with international standards and FDA guidance documents. The bone screws were tested and found to be in conformance with ASTM F543-07 Standard Specification and Test Methods for Metallic Bone Screws.
Comparison with Predicate Device
The Medacta Bone Screws have the same indications for use and contraindications as the Evolis predicate device system with which they are intended to work. The Medacta Bone Screws are made of the same type of material as the Plus predicate device. They come in the same thread diameter as the Plus predicate and come in lengths within the range of the predicate device screw lengths.
Conclusion:
The data and information provided in this submission support the conclusion that the Medacta Bone Screws are substantially equivalent to its predicate devices. Plus Cancellous Bone Screws with respect to technological characteristics. The Medacta Bone Screws have the same indications for use as the Evolis Total Knee System with which they are intended to work. Actual device performance as tested conforms to applicable standards and FDA guidance.
. Page 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDACTA International SA % Ms. Natalie J. Kennel Consultant 13721 Via Tres Vista San Diego, California 92129
JUN - 1 2009
Re: K091069
Trade/Device Name: Medacta Bone Screws Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Regulatory Class: II Product Code: JWH, HWC Dated: May 29, 2009 Received: June 28, 2009
Dear Ms. Kennel:
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 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-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.
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Page 2- Ms. Natalie J. Kennel
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Oarbaro Buchet
Mark N. Melkerso Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K091069
Indications for Use Statement
510(k) Number (if known): K091069
Device Name: Medacta Bone Screws
Indications for Use:
The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System.
The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic . arthritis, rheumatoid arthritis or polyarthritis
- avascular necrosis of femoral condyle .
- post traumatic loss of joint confiquration .
- primary implantation failure.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Brimm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K091069
§ 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.