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:

· Depuy Synthes'

o GLOBAL® APG+ Shoulder System (K052472),
o DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077)
o GLOBAL® STEPTECH® APG Shoulder System (K092122).

• DJO's

o Reverse® Shoulder Prosthesis (K051075, K111629, K092873).
o Turon® Shoulder System (K080402)
o AltiVate™ Anatomic Shoulder System (K162024)
· Integra's

o Titan™ Total Shoulder System (K100448, K112438, K142413, K152047)

o Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999)
Lima's
- o SMRTM Shoulder System (K100858),
- o SMRTM Reverse Shoulder System (K110598),
- o SMRTM Modular Glenoid (K113254) (K143256),
- o SMR™ 3-Pegs Glenoid (K130642),
- o SMR™ TT Metal Back Glenoid (K133349),
- o SMRTM 40mm Glenosphere (K142139).

· Stryker's

o ReUnion RSA Reverse Shoulder System (K183039)
o 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 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 patient-specific 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 pre-operative planning of the surgeon. The graft serves as a visual reference for the surgeon in the OR.

The Materialise Shoulder Guide and Models must only be used within the intended use of the compatible components.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in a quantitative research sense. The document is a 510(k) premarket notification summary from the FDA, focusing on demonstrating substantial equivalence to a predicate device rather than presenting formal study results against predefined acceptance metrics.

However, based on the information provided, we can infer some "acceptance criteria" through the lens of substantial equivalence and list reported device performance related to this equivalence.

Here's an attempt to extract and frame the information according to your request, acknowledging the limitations of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria are not stated, we will infer them based on the substantial equivalence argument made by the manufacturer. The reported performance is based on the claim of similarity to the predicate device and the results of verification and validation activities mentioned.

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance (Based on Manufacturer's Claims)
Hardware Performance:
Biocompatibility requirements met.	Previous testing for biocompatibility is applicable and demonstrates substantial equivalence.
Cleaning and debris requirements met.	Previous testing for cleaning and debris is applicable and demonstrates substantial equivalence.
Dimensional stability maintained.	Previous testing for dimensional stability is applicable and demonstrates substantial equivalence.
Packaging integrity maintained.	Previous testing for packaging is applicable and demonstrates substantial equivalence.
Accuracy and performance adequate for intended use (transferring pin positioning for glenoid components).	Testing verified that the accuracy and performance of the system is adequate to perform as intended. Stability of device placement and functional elements are the same as the predicate and previously cleared devices. Previously performed simulated surgeries with rapid prototyped bone models and cadaver testing on cleared devices (K153602, K131559) are considered applicable.
Software Performance (SurgiCase Shoulder Planner):
Functionality (planning, visualization, editing, report generation) as intended.	The planning functionality, visualization options, and planning features are exactly the same as for the glenoid planning of the predicate device. The subject device has the same codebase and uses the same methods for design, verification, and validation as the predicate device. Software verification and validation were performed against defined requirements and user needs, following FDA guidance. The technological differences (humeral planning, range of motion, defect quantification, bone removal) have been demonstrated not to affect safety or effectiveness or raise new issues.
No new issues of safety or effectiveness compared to predicate.	The non-clinical performance testing indicates that the subject device is as safe, as effective, and performs as well as the predicate device. The technological differences in software have been demonstrated not to affect safety or effectiveness or raise new issues of safety or effectiveness compared to the predicate device.
Compliance with regulations and quality systems.	The Materialise Shoulder System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (13485) requirements.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "previous simulated surgeries using rapid prototyped bone models and previous cadaver testing on previously cleared devices K153602 and K131559" which are considered applicable to the current device. However, no specific sample sizes (number of bone models or cadavers) for these tests are provided in this summary.

The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated. It can be inferred that these were laboratory-based tests conducted typically by the manufacturer or a third-party testing facility.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth in the context of the simulated surgeries or cadaver testing. The software validation involved "validation against user needs," implying input from intended users (surgeons), but the details are absent.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for evaluating the performance of the device in the context of the "simulated surgeries" or "cadaver testing."

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided text. The submission focuses on substantial equivalence based on technological similarity and prior testing, not on human reader performance improvement with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The software component, "SurgiCase Shoulder Planner," is a planning tool that assists a surgeon. It "allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data." This implies a continuous "human-in-the-loop" interaction for final plan approval. While software verification and validation were performed, the reported performance is within the context of assisting a surgeon, not as a standalone diagnostic or treatment decision-making algorithm. Therefore, a purely standalone (algorithm only without human-in-the-loop performance) study is not explicitly described or claimed. The software verification and validation would involve assessing the algorithm's output accuracy against its intended function (e.g., measurements, reconstructions), but this is not directly presented as "standalone performance" in the clinical decision-making sense.

7. The Type of Ground Truth Used

For the hardware (guidance system), the ground truth for "accuracy and performance" would likely be established through:

Measurement against physical standards: For dimensional accuracy.
Intraoperative positioning verification: During simulated surgeries or cadaver tests, assessing how well the guide facilitates the intended pin placement relative to anatomical landmarks. This would be a technical ground truth based on the precision of the physical guides.

For the software (SurgiCase Shoulder Planner), the ground truth for "validation against user needs" would likely involve:

Expert Consensus/Clinical Expertise: Surgeons reviewing the generated plans, measurements, and reconstructions against their professional judgment and potentially 3D models or other imaging data to deem them clinically acceptable and accurate. This would involve expert consensus on the correctness of the planning outputs.

8. The Sample Size for the Training Set

The document describes premarket notification for a medical device cleared via substantial equivalence, not an AI/ML algorithm that undergoes explicit "training." While the software component has a "code base," it is described as using "exactly the same methods for design and verification and validation as the predicate device" rather than being a deep learning model trained on a dataset. Therefore, the concept of a "training set" in the context of machine learning does not apply as described in this document.

9. How the Ground Truth for the Training Set Was Established

As the concept of a "training set" for a machine learning model is not applicable here, the question of how its ground truth was established is not relevant to this document. The software's "ground truth" (i.e., correctness of its functions and outputs) is established through traditional software verification and validation against defined requirements and user needs, as mentioned in point 7.

Summary

{0}------------------------------------------------

March 20, 2020

Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Materialise NV Veerle Vanderheyden Regulatory Affairs Officer Technologielaan 15 3001 Leuven Belgium

Re: K193560

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: QHE, KWS, PHX Dated: December 20, 2019 Received: December 23, 2019

Dear Veerle Vanderheyden:

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.

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

{1}------------------------------------------------

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 mediation-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,

Michael C. Owens Acting 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K193560

Device Name Materialise Shoulder System

Indications for Use (Describe)

Hardware:

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:

· Depuy Synthes'

o GLOBAL® APG+ Shoulder System (K052472),
o DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077)
o GLOBAL® STEPTECH® APG Shoulder System (K092122).

• DJO's

o Reverse® Shoulder Prosthesis (K051075, K111629, K092873).
o Turon® Shoulder System (K080402)
o AltiVate™ Anatomic Shoulder System (K162024)
· Integra's

o Titan™ Total Shoulder System (K100448, K112438, K142413, K152047)

o Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999)
Lima's
- o SMRTM Shoulder System (K100858),
- o SMRTM Reverse Shoulder System (K110598),
- o SMRTM Modular Glenoid (K113254) (K143256),
- o SMR™ 3-Pegs Glenoid (K130642),
- o SMR™ TT Metal Back Glenoid (K133349),
- o SMRTM 40mm Glenosphere (K142139).

· Stryker's

o ReUnion RSA Reverse Shoulder System (K183039)
o Reunion TSA Total Shoulder Arthroplasty System (K183039).

Software:

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.

{3}------------------------------------------------

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."

{4}------------------------------------------------

Materialise Shoulder System 510(k) Premarket Notification

510(k) Summary

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92

Company name	Materialise N.V.
Establishment registration number	3003998208
Street Address	Technologielaan 15
City	Leuven
Postal code	3001
Country	Belgium
Phone number	+32 16 74 45 71
Fax number	+32 16 39 66 06
Principal Contact person	Veerle Vanderheyden
Contact title	Regulatory Affairs Officer
Contact e-mail address	Regulatory.Affairs@materialise.be
Additional contact person	Sanne Willekens
Contact title	Technical product manager
Contact e-mail address	Sanne.willekens@materialise.be

Submission date

The date of the Traditional 510(k) submission is December 20, 2019.

Submission information

Trade Name	Materialise Shoulder SystemMaterialise Shoulder Guide and ModelsSurgiCase Shoulder Planner
Common Name	Patient specific instrumentation for shoulder arthroplasty + 3Dplanning software
Classification Name	Shoulder joint metal/polymer semi-constrained cementedprosthesis
Primary product code	QHE (21 CFR 888.3660); Shoulder Arthroplasty ImplantationSystem
Additional product codes	KWS (21 CFR 888.3660); Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented;PHX (21 CFR 888.3660); Shoulder Prosthesis, ReverseConfiguration

{5}------------------------------------------------

Predicate Device

The predicate device to which substantial equivalence is claimed:

Trade or proprietary or model name	Materialise Glenoid Positioning SystemMaterialise Glenoid Positioning System Guide andModelsSurgiCase Shoulder Planner
510(k) number	K190286
Decision date	July 8, 2019
Classification product code	KWS (21 CFR 888.3660)
Manufacturer	Materialise N.V.

Reference Device

Trade or proprietary or model name	BLUEPRINT ™ Patient Specific Instrumentation
510(k) number	K162800
Decision date	February 22, 2017
Classification product code	KWS (21 CFR 888.3660)
Manufacturer	Tornier SAS

{6}------------------------------------------------

Device Description

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 patient-specific 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 pre-operative planning of the surgeon. The graft serves as a visual reference for the surgeon in the OR.

The Materialise Shoulder Guide and Models must only be used within the intended use of the compatible components.

Intended Use

Hardware

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:

. Depuy Synthes'
- GLOBAL® APG+ Shoulder System (K052472), O
- DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077) O
- O GLOBAL® STEPTECH® APG Shoulder System (K092122).
DJO's
- o Reverse® Shoulder Prosthesis (K051075, K111629, K092873),
- O Turon® Shoulder System (K080402)
- O AltiVate™ Anatomic Shoulder System (K162024)
Integra's
- O Titan™ Total Shoulder System (K100448, K112438, K142413, K152047)
- O Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999)
Lima's
- O SMR™ Shoulder System (K100858),
- O SMR™ Reverse Shoulder System (K110598),

{7}------------------------------------------------

510(k) Summary

SMR™ Modular Glenoid (K113254) (K143256), O
SMR™ 3-Pegs Glenoid (K130642), o
SMR™ TT Metal Back Glenoid (K133349), O
o SMR™ 40mm Glenosphere (K142139).
Stryker's
- O ReUnion RSA Reverse Shoulder System (K183039)
- Reunion TSA Total Shoulder Arthroplasty System (K183039). O

Software

Functioning of the Device

The Materialise Shoulder System generates a pre-surgical plan based on medical imaging data using 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 (SCSP) 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 and reference devices. The subject device's software is intended for positioning shoulder components, i.e. glenoid components (same as the predicate device) and humeral components. 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 exactly 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 exactly the same methods for design and verification and validation as the predicate device.

{8}------------------------------------------------

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

. The subject device software includes humeral planning, range of motion assessment, defect quantification and bone removal tool. However, the positioning options and visualization options available for humeral planning are technologically the same as for glenoid planning in the predicate device, only applied to a humeral component instead of a glenoid component. The humeral planning feature, range of motion functionality and bone removal tool are present in the reference device: BLUEPRINT™ Patient Specific Instrumentation (K162800).
The subject software technology differences have been demonstrated to not affect safety or effectiveness or raise new issues of safety or 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 to the predicate device.

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 Materialise Glenoid Positioning System K190286 and previously cleared devices 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 against user needs.

Summary

The non-clinical performance testing indicates that the subject device is as safe, as effective, and performs as well as the predicate device. Therefore it can be concluded that the Materialise Shoulder System is substantial equivalent to the predicate device. The Materialise Shoulder System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (13485) requirements.

Regulation Number and Section

§ 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.”