(122 days)
The Medacta Total Hip Prosthesis System is intended for cementless use in total or partial hip arthroplasty and in primary or revision surgery.
Hip replacement is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia
- Avascular necrosis of the femoral head
- Acute traumatic fracture of the femoral head or neck
- Failure of previous hip surgery, joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
The components of the Medacta Total Hip Prosthesis System are intended for single, cementless use, only, and are described below:
a) Quadra® S Femoral Stem: The Quadra® S Femoral Stem is intended for cementless use, and is available in four versions, standard or lateral stem, both in regular or short neck version. The Quadra® S Femoral Stem is intended, as a component of the Mcdacta Total Hip Prosthesis System, for use in total or partial hip arthroplasty and in primary or revision surgery. The Quadra® S Femoral Stem is manufactured from a titanium alloy, according to ISO 5832-11, 1994, Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6aluminium 7-niobium alloy. The stem is sandblasted and the neck has a mirror-polished finish. The Quadra® S Femoral Stem may be used with the Tri-Plus™ Cup System and CoCrMo Femoral Ball Heads.
b) Cobalt Chromium Molybdenum (CoCrMo) Femoral Ball Head: The CoCrMo femoral ball head is intended for mechanical fixation to a mating hip stem such as the Quadra® S Femoral Stem and for use in total or partial hip arthroplasty to provide increased patient mobility and reduced pain by replacing the damaged hip joint, in primary or revision surgery. The CoCrMo femoral ball heads are manufactured from Cobalt Chromium Molybdenum, according to ISO 5832-12, 2007, Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy. The CoCrMo femoral balls heads range in diamcter from 28 mm to 32 mm and may be used with the Quadra® S Femoral Stem and Tri-Plus™ Cup System.
c) Tri-plus™ Cup System: The Tri-plus™ Acetabular shell is a true hemispherical design featuring plasma spray coating which allows the substrate to retain its fatigue strength characteristics. The shell and liner utilize a secure locking mechanism designed to decrease the potential for polyethylenc wear debris. The liner is manufactured from direct-compression molded polyethylene and incorporates anti-rotation features. The locking mechanism allows for secure fixation between the shell and liner. Superior surface tabs designed into liner provides anti-rotation stability and proper liner indexing. The shell is a true hemisphere design available in No-hole, Cluster hole, and Multi-hole options. The liners are available in Neutral and Hooded (10°) options. The Tri-plus™ liners are manufactured from DCM polyethylene. The Tri-plus™ Cup System may be used with the Quadra® S Femoral Stem and CoCrMo femoral ball heads.
This document describes the Medacta Total Hip Prosthesis System, a medical device. The information provided focuses on its substantial equivalence to predicate devices and adherence to relevant standards rather than a study demonstrating its performance against specific acceptance criteria in the way one might expect for a diagnostic or AI-driven device.
Here's an analysis of the provided text in the context of your request for acceptance criteria and a study proving their fulfillment:
The document does not describe a study in the sense of a clinical trial or performance evaluation with specific acceptance criteria and outcome data for the device itself. Instead, it's a 510(k) premarket notification summary, which aims to demonstrate substantial equivalence to already legally marketed predicate devices.
Therefore, for many of your requested points, the answer will be "Not applicable" or "Not provided in this document" as the nature of the submission is different from proving novel performance.
Here's how to break down your request based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: Adherence to FDA recognized standards for mechanical testing for hip prostheses. | Design verification and design validation, including bench testing, was performed according to FDA's Design Control Requirements (21 CFR Part 820.30) and FDA recognized standards for mechanical testing. (Specific quantitative results or individual acceptance criteria are not detailed in this summary.) |
| Material Composition: Conformance to specified ISO standards for titanium alloy and cobalt-chromium-molybdenum alloy. | Quadra® S Femoral Stem: Conforms to ISO 5832-11, 1994. CoCrMo Femoral Ball Head: Conforms to ISO 5832-12, 2007. |
| Sterility: Conformance to specified ISO standards for radiation sterilization. | Conforms to ISO 11137-1:2006 and ISO 11137-2:2006. |
| Substantial Equivalence: Device has similar indications for use and technological characteristics to predicate devices. | The Medacta Total Hip Prosthesis System is substantially equivalent to the predicate devices (K001942, K021178, K063278, K042565) regarding indications for use/intended use and technical characteristics. |
Explanation: The "acceptance criteria" here are primarily the established standards and regulations that a new medical device must meet to be considered safe and effective, or substantially equivalent to existing devices. The "reported device performance" refers to the declaration that these standards and regulations were met through design verification, validation, and material conformity. Specific quantitative performance metrics are not given in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable/Not provided. This document describes bench testing, material conformity, and substantial equivalence, not a clinical study with a "test set" of patients in the typical sense. Bench testing would involve samples of the device components, but the sample size for these tests is not specified.
- Data provenance: Not applicable/Not provided. The "data" primarily refers to internal design control documentation and adherence to international standards.
3. 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. This is not a study requiring expert-established ground truth. The "ground truth" for this type of submission is adherence to recognized standards and established engineering principles for mechanical performance and material compatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving expert adjudication.
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 device is a hip prosthesis, not a diagnostic imaging device or an AI-assisted tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a hip prosthesis, not an algorithm. Bench testing of the physical components can be considered "standalone" performance for the device itself, but not in the context of an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's submission is primarily based on recognized international standards (ISO standards for materials and sterilization) and FDA's Design Control Requirements for demonstrating the safety and effectiveness of a medical implant through mechanical testing and material properties. It also relies on the established safety and effectiveness of the predicate devices to which it claims substantial equivalence.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
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672857 (pg 1/4)
Premarket Notification 510(k) Summary
l ) Submitter Information
-
b) Company Name and Address:
MEDACTA International SA Strada Regina 6874 Castel San Pictro (CH) - CE 0546 Switzerland Phone: + 41 91 696 60 60 Fax: + 41 91 696 60 66 -
c) Contact Name:
Pamela J. Weagraff, Principal Consultant Quintiles Consulting 18 Bridie Lane Norfolk, MA 02056
508-528-1745 Telephone: Facsimile: 978-752-1225 E-mail: pamela.weagraff(@quintiles.com
- d) Date Prepared: February 1, 2008
2) Name of Device
- b) Trade Name: Medacta Total Hip Prosthesis System (Quadra S® Femoral Stem, CoCrMo Femoral Ball Heads and Tri-PlusTM Cup System)
- c) Common Name: Total Hip Prosthesis System
- d) Classification Name and Reference: Part 888.3350 Hip joint metal/polymer semiconstrained cemented prosthesis; Product Code JDI
3) Substantial Equivalence Claimed to Predicate Device
| Total Hip ProsthesisSystem Component | Predicate Device /Manufacturer | K # |
|---|---|---|
| Quadra® S | SL-PLUS® and SLR-PLUS® Stems, Plus Orthopedics AG | K001942 |
| Quadra® S | SL-PLUS® Lateralized Stem, Plus orthopedics AG | K021178 |
| CoCrMo Femoral BallHead | Portland Cobalt Chrome Femoral Head, Portland Orthopaedics, Ltd. | K063278 |
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K072857 (pg 2/4)
| Total Hip ProsthesisSystem Component | Predicate Device /Manufacturer | K # |
|---|---|---|
| Tri-Plus™ Cup System | Not applicable, previously cleared acetabularcups and liners | K042565 |
4) Device Description
The components of the Medacta Total Hip Prosthesis System are intended for single, cementless use, only, and are described below:
a) Quadra® S Femoral Stem
The Quadra® S Femoral Stem is intended for cementless use, and is available in four versions, standard or lateral stem, both in regular or short neck version. The Quadra® S Femoral Stem is intended, as a component of the Mcdacta Total Hip Prosthesis System, for use in total or partial hip arthroplasty and in primary or revision surgery.
The Quadra® S Femoral Stem is manufactured from a titanium alloy, according to ISO 5832-11, 1994, Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6aluminium 7-niobium alloy. The stem is sandblasted and the neck has a mirror-polished finish.
The Quadra® S Femoral Stem may be used with the Tri-Plus™ Cup System and CoCrMo Femoral Ball Heads.
b) Cobalt Chromium Molybdenum (CoCrMo) Femoral Ball Head
The CoCrMo femoral ball head is intended for mechanical fixation to a mating hip stem such as the Quadra® S Femoral Stem and for use in total or partial hip arthroplasty to provide increased patient mobility and reduced pain by replacing the damaged hip joint, in primary or revision surgery.
The CoCrMo femoral ball heads are manufactured from Cobalt Chromium Molybdenum, according to ISO 5832-12, 2007, Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy.
The CoCrMo femoral balls heads range in diamcter from 28 mm to 32 mm and may be used with the Quadra® S Femoral Stem and Tri-Plus™ Cup System.
c) Tri-plus™ Cup System
The Tri-plus™ Acetabular shell is a true hemispherical design featuring plasma spray coating which allows the substrate to retain its fatigue strength characteristics. The shell and liner utilize a secure locking mechanism designed to decrease the potential for polyethylenc wear debris. The liner is manufactured from direct-compression molded polyethylene and incorporates anti-rotation features. The locking mechanism allows for
{2}------------------------------------------------
secure fixation between the shell and liner. Superior surface tabs designed into liner provides anti-rotation stability and proper liner indexing. The shell is a true hemisphere design available in No-hole, Cluster hole, and Multi-hole options. The liners are available in Neutral and Hooded (10°) options. The Tri-plus™ liners are manufactured from DCM polyethylene. The Tri-plus™ Cup System may be used with the Quadra® S Femoral Stem and CoCrMo femoral ball heads.
5) Intended Use / Indications for Use
The Medacta Total Hip Prosthesis System is intended for ccmentless use in total or partial hip arthroplasty and in primary or revision surgery.
Hip replacement is indicated in the following cases:
- 프 Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia
- 트 Avascular necrosis of the femoral head
- Acute traumatic fracture of the femoral head or neck
- 트 Failure of previous hip surgery, joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
6) Predicate Device Comparison of Indications for Use / Intended Use and Technical Characteristics
The comparison of the Medacta Total Hip Prosthesis System was based on a review of relevant Design Control documentation, which are included in the company's 510(k) Premarket Notification, and information concerning the predicate devices that was obtained from the FDA web site and the predicate device manufacturers' web sites. The comparison considered technological characteristics and the indications for use / intended use.
7) Performance Data
Note: No performance standards applicable to this device have been adopted under Section 514 of the Food Drug and Cosmetic Act, with respect to the applicable classifications or product codes.
The materials used to manufacture Medacta Total Hip Prosthesis System components conform to the following FDA recognized standards:
- a) Materials:
Quadra® S Femoral Stem: ISO 5832-11, 1994, Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
CoCrMo Femoral Ball Head: ISO 5832-12, 2007, Implants for surgery -- Metallic
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K072857 (pg 4/4)
materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy
- b) Sterility:
ISO 11137-1:2006, Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2, 2006, Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
- c) Performance Testing:
Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30, and in accordance to FDA recognized standards for mechanical testing.
8) Conclusion:
The information and data provided in this 510(k) Premarket Notification establish that the Medacta Total Hip Prosthesis System is substantially equivalent to the afore-mentioned predicate devices with respect to indications for use/intended use, and technical characteristics.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Re:
FEB 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDACTA International SA % Quintiles Consulting Ms. Pamela J. Weagraff Principle Consultant 18 Birdie Lane Norfolk, MA 02056
K072857 Trade/Device Name: Medacta Total Hip Prosthesis Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer/metal semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI Dated: January 7, 2008 Received: January 8, 2008
Dear Ms. Weagraff:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. Pamela J. Weagraff
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mullison
Mark N. Melkerson i Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K072857 (pg 1/1)
ODE Indications Statement
510(k) Number (if known): Unknown
Device Name: Medacta Total Hip Prosthesis System
Indications for Use:
The Medacta Total Hip Prosthesis System is intended for cementless use in total or partial hip arthroplasty and in primary or revision surgery.
Hip replacement is indicated in the following cases:
- 미 Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia
- l Avascular necrosis of the femoral head
- 트 Acute traumatic fracture of the femoral head or neck
- 트 Failure of previous hip surgery, joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use: __ AND/OR (21 CFR 801 Subpart D)
Over-the-Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Choubara huchum
Division of General, Restorative, and Neurological Devices
510(k) Number K072657
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.