The VIP Glenoid Targeter is a manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates.
The VIP Glenoid Reamer is intended for use with the VIP Glenoid Targeter in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.
The indications for use of the Arthrex shoulder systems with which the VIP glenoid instrumentation is intended to be used are the same as those described in the labeling for these shoulder systems.
The OrthoVis preoperative plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.
The VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates. The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.
The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.
The VIP Web portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis desktop software by trained Arthrex technicians.
The VIP Web portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis preoperative plan. It is indicated for use with the following glenoid implant lines: Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates.

Device Description

The subject VIP glenoid reamers are made of stainless-steel. The subject device is designed for use with the Univers VaultLock glenoid and Univers Revers MGS baseplates. These glenoid components are within the indications cleared for Arthrex VIP System under K162697 and K193523. The subject VIP glenoid reamers consist of a primary reamer (pilot) and a secondary reamer (glenoid-implant specific: Univers VaultLock [with/without augment] or Univers Revers MGS [with/without augment]). The reaming depth settings for the subject devices is provided with the surgeon approved plan.

AI/ML Overview

The Arthrex Virtual Implant Positioning (VIP) System (K222007) is a medical device designed to facilitate preoperative planning and intraoperative placement of glenoid components in total shoulder replacement. The system comprises the VIP Glenoid Targeter (manual instrument system), VIP Glenoid Reamer, OrthoVis pre-operative plan (software-generated plan), and the VIP Web Portal (software interface for imaging and plan display/editing).

1. Acceptance Criteria and Reported Device Performance:

The provided text details performance data for the VIP Glenoid Reamers and the overall VIP System. Since this is a 510(k) submission, the primary acceptance criteria revolve around substantial equivalence to predicate devices, demonstrating that the subject device performs as intended and does not raise new questions of safety or effectiveness. Specific numerical acceptance criteria were not explicitly stated in the provided summary, but the general criteria and reported performance can be summarized as follows:

Acceptance Criteria (Inferred from 510(k) approach)	Reported Device Performance
Functional Equivalence: Device performs as intended, facilitating accurate preoperative planning and intraoperative placement of glenoid components.	Demonstrated Function: "Design verification (compression testing and side-by-side testing) and cadaver validation were performed." "The verification and validation activities conducted for the subject VIP glenoid reamers demonstrates that it performs as intended for the desired indications."
Depth Control Accuracy (VIP Glenoid Reamers): Maintains appropriate control over reaming depth.	Accuracy Demonstrated: "Side-by-by-side testing with the standard reaming method was conducted to assess the primary reaming depth control accuracy of the VIP Reaming Instrumentation System." (Specific accuracy metrics not provided, but implies satisfactory performance).
Software Functionality and Safety: Software components (OrthoVis Preoperative Plan, VIP Web Portal) are properly verified and validated, and do not introduce new safety or effectiveness concerns.	Software V&V Completed: "Software verification and validation testing of the Arthrex VIP Web Portal software and Arthrex OrthoVis Desktop software were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was considered as a "major" level of concern. Activities included software validation/verification, regression testing, unit testing, code reviews and checks and integration testing."
Overall System Safety and Effectiveness: The entire VIP system, including the new reamers and modifications, is safe and effective for its intended use.	Established Safety and Effectiveness: "Cadaveric validation was performed to validate the related user needs, intended use, safety and effectiveness of the subject VIP glenoid instrumentation." "The overall planning process, materials, sterilization methods, principles of operation, have not changed from the predicates. Any differences with the predicate are considered minor and do not raise questions regarding safety or effectiveness."
Material Biocompatibility/Safety: Materials used are safe for their intended application.	Material Equivalence: "subject VIP glenoid reamers are made of stainless-steel." "The overall planning process, materials, sterilization methods, principles of operation, have not changed from the predicates." (Implies materials are known and safe, similar to predicates).

2. Sample Size for Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated for either the mechanical testing (compression, side-by-side) or the cadaveric validation.
Data Provenance: The cadaveric validation implies human anatomical specimens were used, likely from a cadaver lab setting. The country of origin is not specified but commonly such studies are conducted in the country of device development or major academic centers. The study appears to be prospective in nature, as new tests were conducted for the device.

3. Number of Experts and Qualifications:

For Cadaveric Validation: Not explicitly stated how many experts were involved or their specific qualifications. However, such studies typically involve orthopedic surgeons specializing in shoulder surgery to assess the surgical workflow and outcomes.
For Software Verification & Validation: The summary mentions "trained Arthrex technicians" generating surgical treatment options in the OrthoVis desktop software. These technicians would likely be experts in the use of the software and anatomical planning.

4. Adjudication Method:

The document does not specify an adjudication method for the testing or validation activities.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No mention of an MRMC comparative effectiveness study being performed to assess the effect size of human readers improving with AI vs. without AI assistance. The device is for pre-operative planning and intra-operative guidance, not a diagnostic AI tool for image interpretation by multiple readers.

6. Standalone (Algorithm Only) Performance:

The software components (OrthoVis Preoperative Plan, VIP Web Portal) represent the "algorithm only" parts of the system for planning and displaying information. The summary states that "Software verification and validation testing... were conducted". This implies that the standalone performance of the software was assessed for its intended functions, such as accurate planning and display, as part of the V&V process. However, specific metrics for standalone performance are not provided.

7. Type of Ground Truth Used:

For Mechanical Testing (Compression and Side-by-Side): The ground truth would be precise engineering measurements and pre-defined specifications for depth control and material properties.
For Cadaveric Validation: The ground truth would be the actual anatomical landmarks and the accuracy of implant placement achieved within the cadaveric model, often verified through post-procedure imaging or dissection.
For Software Verification & Validation: The ground truth for software would be the expected output based on validated algorithms and reference data, ensuring internal consistency and correctness of computations and displays.

8. Sample Size for Training Set:

The document does not provide information about a "training set" in the context of machine learning or AI models. This device appears to be rule-based or algorithm-based software for planning, rather than a machine learning model that requires a distinct training set. The "trained Arthrex technicians" mentioned are users of the software, not data for a training set.

9. How Ground Truth for Training Set Was Established:

As the document does not indicate the use of a machine learning training set, this question is not applicable.

Summary

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March 8, 2023

Arthrex Inc. Ivette Galmez Regulatory Affairs Prinicipal Specialist 1370 Creekside Boulevard Naples, Florida 34108

Re: K222007

Trade/Device Name: Arthrex Virtual Implant Positioning (VIP) System 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, LLZ Dated: February 9, 2023 Received: February 10, 2023

Dear Ivette Galmez:

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

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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 (OS) 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,

Farzana
Digitally signed by
Farzana Sharmin -S
Sharmin -S Date: 2023.03.08
12:24:11-05'00'

For Jiping Chen, MD, Ph.D., M.P.H. Division 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)

K222007

Device Name

Arthrex Virtual Implant Positioning (VIP) System - VIP Glenoid Instrumentation

Indications for Use (Describe)

The VIP Glenoid Reamer is intended for use with the VIP Glenoid Targeter in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.

The indications for use of the Arthrex shoulder systems with which the VIP glenoid instrumentation is intended to be used are the same as those described in the labeling for these shoulder systems.

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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Indications for Use

510(k) Number (if known)

K22007

Device Name

Arthrex Virtual Implant Positioning (VIP) System - OrthoVis Preoperative Plan

Indications for Use (Describe)

The OrthoVis preoperative plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.

The VIP Glenoid Targeter is indicated for use with the Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates.

The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.

The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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."

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Indications for Use

510(k) Number (if known)

K22007

Device Name

Arthrex Virtual Implant Positioning (VIP) System - VIP Web Portal

Indications for Use (Describe)

The VIP Web portal is intended for use as a software interface of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis desktop software by trained Arthrex technicians.

The VIP Web portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis preoperative plan. It is indicated for use with the following glenoid implant lines: Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates.

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.

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.

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."

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510(k) Summary

Date Prepared	March 7, 2023
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Ivette GalmezRegulatory Affairs Principal Specialist1-239-643-5553, ext. 71263ivette.galmez@arthrex.com
Name of Device	Arthrex Virtual Implant Positioning (VIP) System
Common Name	Total shoulder replacement system/instruments, Preoperative planning software/plan, PreoperativePlanning Web software
Product Code	QHE, KWS, PHX, LLZ
Classification Name	21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class	II
Primary Predicate	K162697: Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan,SmartBase for Arthrex Glenoid Iris, Arthrex VIP Web Portal
Secondary Predicate	K212560: Signature™ ONE System
Reference Device	K193523: Arthrex VIP Web Portal
Purpose of Submission	This traditional 510(k) premarket notification is submitted to obtain clearance for the VIP glenoidreamers as a line extension to the Arthrex VIP System cleared under K162697. This submission includesmodifications to the VIP glenoid targeter (formerly glenoid IRI) which were previously documented vialetter to file, and VIP software updates.
Device Description	The subject VIP glenoid reamers are made of stainless-steel. The subject device is designed for use withthe Univers VaultLock glenoid and Univers Revers MGS baseplates. These glenoid components arewithin the indications cleared for Arthrex VIP System under K162697 and K193523. The subject VIPglenoid reamers consist of a primary reamer (pilot) and a secondary reamer (glenoid-implant specific:Univers VaultLock [with/without augment] or Univers Revers MGS [with/without augment]). Thereaming depth settings for the subject devices is provided with the surgeon approved plan.
Indications for Use	The VIP Glenoid Targeter is a manual instrument system intended to facilitate preoperative planningand intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid intotal shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoidimplant. The VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex totalshoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component,as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modularglenoid system (MGS) baseplates.The VIP Glenoid Reamer is intended for use with the VIP Glenoid Targeter in total shoulder systemsthat utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The VIP GlenoidReamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™modular glenoid system (MGS) baseplates.The indications for use of the Arthrex shoulder systems with which the VIP glenoid instrumentation isintended to be used are the same as those described in the labeling for these shoulder systems.The OrthoVis preoperative plan is a preoperative plan created via the OrthoVis software that facilitatesaccurate preoperative planning and intraoperative placement of the glenoid component in totalshoulder replacement.The VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total shouldersystems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well asthe Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoidsystem (MGS) baseplates. The VIP Glenoid Reamer is indicated for use with the Univers VaultLock®glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan isintended to be used are the same as those described in the labeling for these shoulder systems.

Indications for Use(continue)	The VIP Web portal is intended for use as a software interface and for the transfer of imaginginformation from a medical scanner such as a CT scanner. It is also intended as software fordisplaying/editing implant placement and surgical treatment options that were generated in theOrthoVis desktop software by trained Arthrex technicians.The VIP Web portal is intended for use with the VIP glenoid instrumentation and with the OrthoVispreoperative plan. It is indicated for use with the following glenoid implant lines: Univers™ II andUnivers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock®glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) andUnivers Revers™ modular glenoid system (MGS) baseplates.
Summary ofTechnologicalCharacteristics	The subject VIP glenoid reamers, except for the secondary reamers for the augmented MGS, arereusable instruments. All VIP glenoid reamers are made of stainless steel. The subject VIP reamers areused in conjunction with the VIP glenoid targeter instrument. The subject VIP reamers are used in placeof the standard glenoid reaming instrumentation. The subject reamers are designed with depth controlfeatures having similar function to the disposable reaming guide instrumentation in Zimmer-BiometSignature One system (K212560). The settings for the reaming depth are reviewed during preoperativeplanning and approved by the surgeon. The reaming depth settings for the subject devices is providedwith the surgeon approved plan.
	The subject VIP glenoid instrumentation has the same fundamental scientific technology (transfer a pre-operative plan to the orthopedic surgical procedure) as the primary predicate (K162697) and secondarypredicate (K212560).
Performance Data	Design verification (compression testing and side-by-side testing) and cadaver validation wereperformed. Compression testing was conducted to assess the function of the depth control features ofthe VIP glenoid reamers. Side-by-side testing with the standard reaming method was conducted toassess the primary reaming depth control accuracy of the VIP Reaming Instrumentation System.
	Cadaveric validation was performed to validate the related user needs, intended use, safety andeffectiveness of the subject VIP glenoid instrumentation.
	Software verification and validation testing of the Arthrex VIP Web Portal software and ArthrexOrthoVis Desktop software were conducted and documentation was provided as recommended byFDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices." The software was considered as a "major" level of concern.Activities included software validation/verification, regression testing, unit testing, code reviews andchecks and integration testing.
Conclusion	The subject devices are substantially equivalent to the predicates in which the basic design features,technological characteristics, principles of operation and intended use and indications are similar or thesame as the predicates. The verification and validation activities conducted for the subject VIP glenoidreamers demonstrates that it performs as intended for the desired indications. The subject VIP glenoidreamers, when used in conjunction with the Arthrex VIP System is substantially equivalent to thepredicate. The addition of the subject VIP glenoid reamer, as well as the modifications to the VIPglenoid targeter and software updates do not raise new questions of safety or effectiveness. Theoverall planning process, materials, sterilization methods, principles of operation, have not changedfrom the predicates. Any differences with the predicate are considered minor and do not raisequestions regarding safety or effectiveness.Based on the intended use and indications, technological characteristics, principle of operation and thesummary of data submitted, Arthrex Inc. has determined that the subject device is substantiallyequivalent to the currently marketed predicate device.

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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.”