The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Blueprint® is a medical device for surgeons.

Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery. Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format. Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. Blueprint® allows surgeons to design patient specific components (patient-specific instruments and Shoulder iD™ Primary Reversed Glenoid*) based on the pre-surgical plan.

Blueprint® leads to the generation of a planning report.

Blueprint® is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.

Note: Measures and patient specific guide design are provided depending on the case profiles. *Only if patient-specific instruments or Shoulder iD™ Primary Reversed Glenoid are available in your geography.

The Shoulder iD™ Primary Reversed Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

· Rheumatoid arthritis

· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Revision of glenohumeral joint if sufficient native glenoid bone remains

All components are single use.

The Shoulder iD™ Primary Reversed Glenoid implant is anchored to the bone with screws and is for non-cemented fixation.

Note: A CT Scan is used to create the Shoulder iD™ Primary Reversed Glenoid implant

Device Description

BLUEPRINT™ Patient Specific Instrumentation
Blueprint Patient Specific Instrumentation is composed of two components: Blueprint Glenoid Guides (hardware) and Blueprint Planning Software (software)

Blueprint™ Glenoid Guides
The Blueprint Glenoid Guides are patients specially designed to facilitate the implantation of Wright-Tornier glenoid prostheses.

The Blueprint Glenoid Guides are designed and manufactured based on a pre-operated only by the software Blueprint Planning Software.

Blueprint™ Planning Software
Blueprint Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer and is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed).

It is intended to help to plan an operation by allowing surgeons to:

· Plan for shoulder arthroplasty cases
· Position and select glenoid and humeral implants,
· Simulate the prosthetic range of motion,
· Interact with implants and different computed measurements
· Generate information required to design a patient-specific glenoid component when appropriate.

Shoulder iD™ Primary Reversed Glenoid
The Shoulder iD Primary Reversed Glenoid implant (Shoulder iD) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis.

The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis.

AI/ML Overview

This FDA 510(k) clearance letter and its accompanying summary focus on demonstrating substantial equivalence to predicate devices for two components: "Blueprint Patient-Specific Instrumentation" (software and hardware) and "Shoulder iD Primary Reversed Glenoid" (implant). The document primarily addresses the comparison of indications for use and technological characteristics, and broadly mentions performance testing.

Crucially, the provided text does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria in the format requested. The document mentions "performance testing" and "verification and validation evaluations" but does not elaborate on the specific metrics, results, or methodologies used.

Therefore, I cannot populate the table or answer most of the questions directly. However, I can extract what is implied or stated generally:

Implicit information from the FDA 510(k) context:

Acceptance Criteria (Implied): For a 510(k) clearance, the primary acceptance criterion is substantial equivalence to existing legally marketed devices. This means demonstrating that the new device is as safe and effective as the predicate, and does not raise new questions of safety or effectiveness. For the software, this typically involves demonstrating accuracy, reliability, and functionality consistent with its intended use (pre-surgical planning). For the hardware (guides) and the implant, this involves demonstrating appropriate mechanical properties, fit, and biocompatibility.
Study Type (Implied): Given it's a 510(k) without clinical studies, the studies would primarily be non-clinical performance testing (e.g., mechanical testing, dimensional accuracy, software verification and validation).

Here's what can be extracted and what is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied/General)	Reported Device Performance (Summary from text)
Functional equivalence to predicate software (pre-surgical planning)	"Verification and validation evaluations" confirm operating principle is the same as predicate. Differences in design specifications 'do not raise new questions of safety and effectiveness as demonstrated in validation testing.'
Dimensional and functional equivalence for hardware (glenoid guides)	"Dimensional and cadaveric tests performed on the predicate device hardware... are still applicable on the subject hardware device as the changes... do not impact functional dimensions nor material."
Mechanical performance/stability of the implant (Shoulder iD Primary Reversed Glenoid)	"Non-clinical Reverse Glenoid Loosening testing was confirmed substantial equivalence to the predicate device in manual bone preparation conditions."
Overall safety and effectiveness	Device does not raise "any different questions of safety and effectiveness over the predicate device."

Missing specific details:

Quantitative acceptance thresholds (e.g., accuracy +/- X mm, specific mechanical test results).
Detailed breakdown of results for each criterion.

2. Sample Size and Data Provenance:

Test Set Sample Size: Not specified. The document mentions "cadaveric test" for the guides and "Non-clinical Reverse Glenoid Loosening testing" for the implant, but no sample sizes are given for these tests. For software verification and validation, typically a set of test cases is used, but the size or nature of these cases is not described.
Data Provenance: The company (Stryker Corporation (Tornier, S.A.S.)) is based in France. The letter does not specify the country of origin of the test data. The studies are non-clinical (e.g., benchtop, cadaveric, software testing), not clinical trials on patients, therefore the retrospective/prospective distinction for patient data does not directly apply in the usual sense.

3. Number of Experts and Qualifications for Ground Truth:

Not specified. Given that no clinical studies were performed, and the emphasis is on substantial equivalence through non-clinical testing and software V&V, the "ground truth" would likely be established through engineering specifications, validated simulation models, or anatomical measurements rather than expert clinical consensus on patient data.
If expert review was involved in the software V&V or cadaveric studies (e.g., assessing anatomical landmark identification), their number and qualifications are not mentioned.

4. Adjudication Method for the Test Set:

Not applicable / Not specified. Without details on how ground truth was established by experts on a test set (e.g., image annotations), an adjudication method cannot be inferred.

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

No, not specified. The document explicitly states: "No clinical studies were performed." MRMC studies typically involve human readers interpreting medical images, usually in a clinical context, which wasn't part of this submission for demonstrating substantial equivalence. The device is a planning software and instrumentation, not primarily one for diagnostic interpretation by human readers.

6. Standalone (Algorithm-Only) Performance:

Implicitly yes, for software verification and validation. The document states that "Technological differences between the subject and predicate software are supported with verification and validation evaluations." This suggests testing of the software's algorithms and functionalities independently. However, specific standalone performance metrics (e.g., accuracy of measurements, success rate of planning) are not detailed. The software is described as a "pre-surgical planner" that allows surgeons to "visualize, measure, reconstruct, and annotate anatomic data" and "design patient-specific components." The V&V would assess these capabilities.

7. Type of Ground Truth Used:

For the hardware (guides): Likely dimensional measurements (engineering specifications) and anatomical landmarks/fit in cadaveric models.
For the software: Likely engineering specifications, validated computational models, known anatomical dimensions from source CT data, and consistency checks against surgeon input/expectations during planning scenarios.
For the implant: Mechanical testing standards and measurements (e.g., loosening, fatigue strength) compared against predicate performance.

8. Sample Size for the Training Set:

Not specified. The document describes a "Blueprint Planning Software" but does not explicitly state it's an AI/machine learning model that requires a "training set" in the sense of supervised learning. It's described as software that allows surgeons to perform planning functions, implying it might be a rule-based system or an advanced visualization and measurement tool, rather than a learning algorithm. If there is an AI component, the training set size is not provided.

9. How the Ground Truth for the Training Set was Established:

Not specified and not directly applicable unless the "Blueprint Planning Software" incorporates machine learning and has a distinct "training set." If it does, and assuming the software assists in identifying anatomical landmarks or making measurements, the ground truth for training data would typically be established by expert radiologists or orthopedic surgeons annotating CT scans.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters FDA in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 10, 2024

Stryker Corporation (Tornier, S.A.S.) Aymen Azaiez Principal Regulatory Affairs Specialist 161 rue Lavoisier Montbonnot-Saint-Martin, 38330 France

Re: K241491

Trade/Device Name: Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, QHE Dated: September 6, 2024 Received: September 6, 2024

Dear Aymen Azaiez:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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 Date: 2024.10.10 Sharmin -S 12:23:24 -04'00'

Farzana Sharmin, PhD 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

Submission Number (if known)

K241491

Device Name

Blueprint Patient-Specific Instrumentation: Shoulder iD Primary Reversed Glenoid

ndications for Use (Describe)

BLUEPRINT™ Patient Specific Instrumentation IFU:

Hardware

Software

Blueprint® is a medical device for surgeons.

Blueprint® leads to the generation of a planning report.

Blueprint® is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.

Shoulder iD™ Primary Reversed Glenoid IFU:

· Rheumatoid arthritis

· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Revision of glenohumeral joint if sufficient native glenoid bone remains

All components are single use.

The Shoulder iD™ Primary Reversed Glenoid implant is anchored to the bone with screws and is for non-cemented fixation.

Note: A CT Scan is used to create the Shoulder iD™ Primary Reversed Glenoid implant

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.

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510(k) #: K241491	510(k) Summary		Prepared on: 2024-09-09
Contact Details			21 CFR 807.92(a)(1)
Applicant Name		Stryker Corporation (Tornier, S.A.S.)
Applicant Address		161 rue Lavoisier Montbonnot-Saint-Martin 38330 France
Applicant Contact Telephone		+33648381036
Applicant Contact		Mr. Aymen Azaiez
Applicant Contact Email		aymen.azaiez@stryker.com
Correspondent Name		Stryker Corporation (Tornier S.A.S.)
Correspondent Address		161 rue Lavoisier Montbonnot-Saint-Martin 38330 France
Correspondent Contact Telephone		+33648381036
Correspondent Contact		Mr. Aymen Azaiez
Correspondent Contact Email		aymen.azaiez@stryker.com
Device Name			21 CFR 807.92(a)(2)
Device Trade Name		Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid
Common Name		Shoulder Prosthesis, Reverse Configuration
Classification Name		Shoulder joint metal/polymer semi-constrained cemented prosthesis
Regulation Number		888.3660
Product Code(s)		PHX, KWS, QHE
Legally Marketed Predicate Devices			21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)		Product Code
K232265	BLUEPRINT™ Pati et Specific Instrumentation		PHX
K211359	BLUEPRINT™ Patient Specific Instrumentation + Tornier Perform		PHX
K222987 (Reference)	Akunah REFLECT		LLZ
Device Description Summary			21 CFR 807.92(a)(4)
BLUEPRINT™ Patient Specific InstrumentationBlueprint Patient Specific Instrumentation is composed of two components: Blueprint Glenoid Guides (hardware) and Blueprint Planning Software (software)

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Blueprint™ Glenoid Guides

The Blueprint Glenoid Guides are patients specially designed to facilitate the implantation of Wright-Tornier glenoid prostheses.

The Blueprint Glenoid Guides are designed and manufactured based on a pre-operated only by the software Blueprint Planning Software.

Blueprint™ Planning Software

Blueprint Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer and is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed).

It is intended to help to plan an operation by allowing surgeons to:

· Plan for shoulder arthroplasty cases
· Position and select glenoid and humeral implants,
· Simulate the prosthetic range of motion,
· Interact with implants and different computed measurements
· Generate information required to design a patient-specific glenoid component when appropriate.

Shoulder iD™ Primary Reversed Glenoid

The Shoulder iD Primary Reversed Glenoid implant (Shoulder iD) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis.

The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

BLUEPRINT™ Patient Specific Instrumentation IFU:

Hardware

Software

Blueprint® is a medical device for surgeons.

Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery.

Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format.

Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data.

Blueprint® allows surgeons to design patient-specific instruments and Shoulder iD™ Primary Reversed Glenoid*) based on the pre-surgical plan.

Blueprint® leads to the generation of a planning report.

Blueprint® is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.

Note: Measures and patient specific guide design are provided depending on the case profiles.

*Only if patient-specific instruments or Shoulder iD™ Primary Reversed Glenoid are available in your geography.

Shoulder iD™ Primary Reversed Glenoid IFU:

The Shoulder iD™ Primary Reversed Glenoid in indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

· Rheumatoid arthritis

· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Revision of glenohumeral joint if sufficient native glenoid bone remains

All components are single use.

The Shoulder iD™ Primary Reversed Glenoid implant is anchored to the bone with screws and is for non-cemented fixation. Note: A CT Scan is used to create the Shoulder iD™ Primary Reversed Glenoid implant

Indications for Use Comparison

21 CFR 807.92(a)(5)

For BLUEPRINT Patient Specific Instrumentations for use of the subject device are identical to the predicate device. For Shoulder iD Primary Reversed Glenoid, the indications for use of the subject device (Shoulder iD Primary Reversed Glenoid) and of the predicate device (Tornier Perform Patient-Matched Primary Reversed Glenoid) are identical except for the name of the device.

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Technological Comparison

21 CFR 807.92(a)(6)

BLUEPRINT Patient Specific Instrumentation

The subject and predicate hardware devices have identical technological features.

Technological differences between the subject and predicate software devices do not raise any different questions of safety and effectiveness and they are addressed though performance testing.

Shoulder iD Primary Reversed Glenoid.

The Shoulder iD Primary Reversed Glenoid and the predicate Tornier Perform Patient-Matched Primary Reversed Glenoid have the same technological features. The only differences between the subject and the brand name and the updated Operative Technique for the subject device. The difference in the operative technique does not raise any different questions of safety and effectiveness and is addressed though performance testing.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

BLUEPRINT™ Patient Specific Instrumentation:

Technological differences between the subject and predicate hardware devices are supported by the dimensional the predicate device hardware which remain applicable to the subject hardware device, as the subject device do not impact functional dimensions or material, and cadaveric test performed on the subject device.

Technological differences between the subject and predicate software are supported with verification and validation evaluations. The operating principle of the subject device is the same as that of the predicate device.

The differences in design specifications do not raise new questions of safety and effectiveness over the predicate device as demonstrated in validation testing.

Shoulder iD Primary Reversed Glenoid

Non-clinical Reverse Glenoid Loosening testing was confirm substantial equivalence to the predicate device in manual bone preparation conditions.

No clinical studies were performed.

BLUEPRINT™ Patient Specific Instrumentation:

The subject device hardware BLUEPRINT™ Patient Specific Instrumentation does not raise any different questions of safety and effectiveness over the predicate device. Technological differences between the subject and predicate are upported by the dimensional and cadaveric tests performed on the predicate device hardware which are still applicable on the subject hardware device as the changes to the subject device do not impact functional dimensions nor material.

Shoulder iD Primary Reversed Glenoid

The Shoulder iD Primary Reversed Glenoid does not raise different questions of safety or effectiveness. There are in technological characteristics between the predicate and subject devices. The results of the Shoulder iD Primary Reversed Glenoid support substantial equivalence to the predicate Tornier Patient-Matched Primary Reversed Glenoid (K211359, cleared November 12, 2021).

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.”