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K Number
K231112
Device Name
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
Manufacturer
Materialise NV
Date Cleared
2023-09-12

(146 days)

Product Code
QHE,KWS,PHX
Regulation Number
888.3660
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
K230315,K220452
Predicate For
K233408
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Hardware:
The Materialise Shoulder Guide and Models are intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.
The Materialise Shoulder Guide and Models are single use only.
The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components:

Software:
SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components. SurgiCase Shoulder Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Shoulder Guide and Models.

Device Description

Materialise Shoulder System™ is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid plan to surgery. The device is a system composed of the following:

  • a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient.
  • Materialise Shoulder Guide and Models, which are a patient-specific guide and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific glenoid guide and models will be manufactured if the surgeon requests patientspecific guides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the preoperative planning of the surgeon. The graft model serves as a visual reference for the surgeon in the OR.
AI/ML Overview

This document is a 510(k) premarket notification for the Materialise Shoulder System™, Materialise Shoulder Guide and Models, and SurgiCase Shoulder Planner. It asserts substantial equivalence to a previously cleared predicate device (K220452).

The provided text does not contain detailed acceptance criteria or the specific study that proves the device meets those criteria for the software component (SurgiCase Shoulder Planner) in the context of AI/ML performance metrics.

The document primarily focuses on demonstrating substantial equivalence based on:

  • Intended Use: The device is a patient-specific medical device to assist in shoulder component placement during total anatomic and reverse shoulder replacement surgery. The software component, SurgiCase Shoulder Planner, is a pre-surgical planner for simulation and assistance in positioning shoulder components.
  • Technological Characteristics: The subject device has similar fundamental technologies, device functionality, and software technology (same code base, design, verification, and validation methods) as the predicate device.
  • Performance Data (Non-Clinical):
    • Hardware: States previous testing for biocompatibility, cleaning, debris, dimensional stability, and packaging are applicable and demonstrate substantial equivalence. Mentions testing verified accuracy and performance, and applicability of simulated surgeries and cadaver testing from previous clearances.
    • Software: States that "Software verification and validation were performed, and documentation was provided following the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.' This includes verification against defined requirements, and validation against user needs."

Therefore, it is not possible to extract the requested information regarding AI/ML-specific acceptance criteria and performance study details from this document. The document describes a traditional 510(k) clearance process, not one with specific AI/ML performance metrics as would be expected for an AI-driven diagnostic or prognostic device. The software "assists" in planning and visualization, it does not appear to perform automated diagnostic or prognostic functions for which detailed performance metrics (like sensitivity, specificity, AUC) would typically be required for FDA clearance.

Based on the provided text, I can only provide the following information as much as possible:

1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria: Not explicitly stated in the document in terms of quantitative performance metrics for the software's "assistance" function. The acceptance criteria seem to be related to demonstrating substantial equivalence in intended use, technological characteristics, and non-clinical performance (including verification and validation against defined requirements and user needs for the software).
* Reported Device Performance:
* Hardware: "Testing verified that the accuracy and performance of the system is adequate to perform as intended." No quantitative metrics are provided.
* Software: "Software verification and validation were performed... This includes verification against defined requirements, and validation against user needs." No quantitative metrics are provided. The document highlights that the software technology differences (addition of one implant component, easier visualization of muscle elongation) "do not affect the safety or effectiveness, or that they do not raise any new issues regarding to the safety and effectiveness compared to the predicate device."

2. Sample size used for the test set and the data provenance:
* Sample Size: Not specified for software performance validation.
* Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not specified. The software is a planning tool to which a surgeon provides input and approves. Ground truth in the context of AI/ML models (e.g., for diagnosis) is not applicable here as the software's function is not a diagnostic one based on the description.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable as no such study is described for the software.

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 described. The software's role is described as assisting in planning and visualization, not as an AI providing interpretations that would be compared to human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. The software is explicitly described as a "pre-surgical planner" that "allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data." It's a human-in-the-loop system for planning, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not applicable in the AI/ML diagnostic sense. The "ground truth" for the software's functionality would be its adherence to specified design requirements and user needs, ensuring it accurately represents anatomical structures and allows for proper planning as intended, rather than a clinical ground truth for a diagnostic output.

8. The sample size for the training set:
* Not specified. The document does not describe a machine learning model that would require a distinct training set in the conventional sense. The "training" for such software would typically involve its development and internal testing against requirements.

9. How the ground truth for the training set was established:
* Not applicable, as no external training set with established ground truth (e.g., clinical labels) is mentioned for a machine learning model.

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September 12, 2023

Materialise NV Giulia Girola Regulatory Affairs Specialist Technologielaan 15 Leuven, 3001 Belgium

Re: K231112

Trade/Device Name: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: OHE, KWS, PHX Dated: July 7, 2023 Received: July 7, 2023

Dear Giulia Girola:

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.

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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 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. Thomas Mcnamara -S

Digitally signed by Thomas Mcnamara -S Date: 2023.09.12 15:07:59 -04'00"

For: Farzana Sharmin, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K231112

Device Name Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner

Indications for Use (Describe)

Hardware

The Materialise Shoulder Guide and Models are intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.

The Materialise Shoulder Guide and Models are single use only.

The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder

Software

SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components. SurgiCase Shoulder Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Shoulder Guide and Models.

1 The implant system was originally cleared under K202716 as the Ignite Anatomic Shoulder System and was rebranded by DePuy Synthes as INHANCE™ Anatomic Shoulder System.

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2 DJO company name changed to Enovis. The shoulder products of Enovis were originally cleared under the company name of DJO (Encore Medical).
-----------------------------------------------------------------------------------------------------------------------------------------------

3 The Integra shoulder portfolio was acquired by Smith+Nephew in 2020. The shoulder products of the Titan™ Shoulder System were transferred from Integra to Smith+Nephew.

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)

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510(k) Summary

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92.18

Company nameMaterialise N.V.
Establishment registration number3003998208
Street AddressTechnologielaan 15
CityLeuven
Postal code3001
CountryBelgium
Phone number+32 16 39 66 11
Fax number+32 16 39 66 06
Primary contact personGiulia Girola
Phone number+39 3285339108
Contact titleRegulatory Affairs Specialist
Contact e-mail addressRegulatory. Affairs@materialise.be
Additional contact personJenny Jones
Contact titleGlobal Quality Regulatory Manager
Contact e-mail addressJenny.Jones@materialise.com

Submission date

The date of the Traditional 510(k) submission is April 17, 2023.

Submission Information

Trade NameMaterialise Shoulder System™Materialise Shoulder Guide and ModelsSurgiCase Shoulder Planner
Common NamePatient specific instrumentation for shoulderarthroplasty + 3D planning software
Classification NameProsthesis, Shoulder, Semi-Constrained,Metal/Polymer Cemented
Primary product codeQHE (21 CFR 888.3660)
Additional product codesKWS (21 CFR 888.3660)PHX (21 CFR 888.3660)

Predicate Device

The predicate device to which substantial equivalence is claimed:

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Trade or proprietary or model nameMaterialise Shoulder System™Materialise Shoulder Guide and ModelsSurgiCase Shoulder Planner
510(k) numberK220452
Decision dateAugust 17, 2022
Classification product codeQHE (21 CFR 888.3660)KWS (21 CFR 888.3660)PHX (21 CFR 888.3660)
ManufacturerMaterialise N.V.

Reference Device

Trade or proprietary or model nameMaterialise Shoulder System™Materialise Shoulder Guide and ModelsSurgiCase Shoulder Planner
510(k) numberK230315
Decision dateMarch 6, 2023
Classification product codeQHE (21 CFR 888.3660)KWS (21 CFR 888.3660)PHX (21 CFR 888.3660)
ManufacturerMaterialise N.V.

Device Description

Materialise Shoulder System™ is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid plan to surgery. The device is a system composed of the following:

  • . a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient.
  • Materialise Shoulder Guide and Models, which are a patient-specific guide and models that are ● based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific glenoid guide and models will be manufactured if the surgeon requests patientspecific guides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the preoperative planning of the surgeon. The graft model serves as a visual reference for the surgeon in the OR.

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Indications for Use

Hardware

The Materialise Shoulder Guide are intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.

The Materialise Shoulder Guide and Models are single use only.

The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components:

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  • -ReUnion RSA Reverse Shoulder System (K183039)
  • -Reunion TSA Total Shoulder Arthroplasty System (K183039)

Software

SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components. SurgiCase Shoulder Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a presurgical plan data file which can be used as input data to design the Materialise Shoulder Guide and Models.

1 The implant system was originally cleared under K202716 as the Ignite Anatomic Shoulder System and was rebranded by DePuy Synthes as INHANCE™ Anatomic Shoulder System.

2DJO company name changed to Enovis. The shoulder products of Enovis were originally cleared under the company name of DJO (Encore Medical).

3 The Integra shoulder portfolio was acquired by Smith+Nephew in 2020. The shoulder products of the Titan™ Shoulder System were transferred from Integra to Smith+Nephew.

Functioning of the Device

The Materialise Shoulder System™ generates a pre-surgical plan based on medical imaging the SurgiCase Shoulder Planner. The SurgiCase Shoulder Planner allows a qualified surgeon to visualize, measure, reconstruct, annotate, edit and approve pre-surgical plan data, which leads to the generation of a case planning report. The SurgiCase Shoulder Planner allows for the creation of a glenoid and/or humeral pre-operative plan. If requested by the surgeon, Materialise Shoulder Guide and Models are designed and manufactured based on the approved glenoid pre-surgical plan. Materialise Shoulder Guide and Models are patient specific templates which transfer the pre-operatively determined pin positioning to the patient intraoperatively assisting the surgeon in positioning glenoid components used with total and reverse shoulder arthroplasty procedures. The Materialise Shoulder Guide and Models are available for glenoid components only.

Technological Characteristics

The Materialise Shoulder System™ has an equivalent intended use and the same fundamental scientific technology as the predicate device. The subject device's software is intended for positioning shoulder components, i.e. glenoid components and humeral components (same as the predicate device). The subject device's hardware is intended for positioning shoulder glenoid components only (same as the predicate device).

Software

The subject software device employs similar fundamental technologies as the predicate software device. Technological similarities include:

  • . Device functionality: The planning functionality, visualization options and planning features are the same for the glenoid planning of the subject device as for the predicate device.
  • Software technology: The subject device has the same code base as the predicate device and uses the same methods for design and verification and validation as the predicate device.

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Following technological differences exist between the subject device software and the predicate device software:

  • The main difference between the subject device and previously cleared predicate device K220452 is the addition of the following Enovis' (the previous company name was DJO) component in the software component of the subject device for the surgeon to select during the planning stage:
    • AltiVate™ Anatomic Augmented Glenoid (K213387).
  • Ability to more easily visualize muscle elongation which previously had to be measured ● manually.

The subject software technology differences have been demonstrated that they do not affect the safety or effectiveness, or that they do not raise any new issues regarding to the safety and effectiveness compared to the predicate device.

Hardware

The subject hardware device is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics compared with the predicate device.

The main difference between the subject device hardware and the predicate device is the extension of compatibility of the SurgiCase Shoulder Guides and Models with additional Enovis' (the previous company name was DJO) Implant component:

  • AltiVate™ Anatomic Augmented Glenoid (K213387). -

Performance Data (non-clinical)

Hardware:

Previous testing for biocompatibility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate substantial equivalence with the predicate device. Testing verified that the accuracy and performance of the system is adequate to perform as intended. The stability of the device placement, surgical technique, intended use and functional elements of the subject device are the same as that of the predicate device of Materialise Shoulder System™ K220452 and previously cleared devices K212569, K193560, K172054, K172054, K170893, K153602 and K131559, and therefore previous simulated surgeries using rapid prototyped bone models and previous cadaver testing on previously cleared devices K153602 and K131559 are considered applicable to the subject device.

Software:

Software verification and validation were performed, and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This includes verification against defined requirements, and validation aqainst user needs.

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Conclusion

The non-clinical performance testing indicates that the subject device is as safe and effective as the predicate device. Therefore, it can be concluded that the Materialise Shoulder System™ is substantially equivalent to the predicate device.

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid 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. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”