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K Number
K241944
Device Name
AGILON® XO Shoulder Replacement System
Manufacturer
implantcast, GmbH
Date Cleared
2025-03-10

(251 days)

Product Code
KWT,HSD,PHX
Regulation Number
888.3650
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:

  • · Non- inflammatory deqenerative joint disease including osteoarthritis and avascular necrosis,
  • · Post-traumatic osteoarthritis.
  • · Fractures,
  • · Rheumatoid arthritis.

The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:

  • · Multi-fragmental comminuted fractures of the humeral head,
  • · 3- and 4-Fragment-fractures of the proximal humerus,
  • · Head-splitting fractures,
  • · Dislocated head-splitting fractures,
  • · Humeral head depression with more than 40% of joint surface depressed,
  • · Interlocking chronic dislocation with deep HILL-SACHS lesion,
  • · Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening),
  • · Posttraumatic humeral head necrosis,
  • · Omarthrosis.

AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.

The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:

  • · Rotator cuff tear arthropathy,
  • · Chronic trauma shoulder,
  • · Decentering of the humeral head after implantation of a humeral head prosthesis.

Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.

In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows:

  • · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
  • · From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
  • · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
  • · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure
  • · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
  • From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
  • · From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
    The device is intended for adults.

The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation.

The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The qlenoid cementless is intended for cementless use with the addition of screws for fixation.

Device Description

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with options depending upon the size and anatomical needs of each patient. The subject submission is for new cancellous screws for use in a total reverse shoulder replacement with the previously cleared K231657 components:

  • Humeral Head Components ●
  • Glenoid and Glenosphere Components ●
  • Humeral Stems and Stem Extension Pieces
  • Metaphyseal Components ●
  • Fixation and Cancellous Screws ●

The subject line extension components are intended for use with previously cleared AGILON XO Shoulder System instruments. There are no changes to packaging, sterility, shelf life, or materials subject to this submission.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AGILON® XO Shoulder Replacement System, focusing on new cancellous screws. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt regarding AI/algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through engineering analysis and limited performance testing of the new cancellous screws. Therefore, I cannot provide all the requested information.

Here's what I can extract and infer from the provided text, along with what is explicitly not available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (for cancellous screws)Reported Device Performance (type of testing)
Sufficient performance for intended use (specific numeric criteria not provided)- Torsional Properties (ASTM F543)- Driving Torque (ASTM F543)- Axial Pull-out Strength (ASTM F543)
Predetermined acceptance criteria met (specific numeric criteria not provided)Testing demonstrated sufficient performance and met predetermined acceptance criteria.
Biocompatibility (per ISO 10993-1)Evaluation completed per ISO 10993-1.
Cleaning, sterilization, packaging, shelf-life, and endotoxin standards metLeveraged from the predicate AGILON® XO Shoulder Replacement System (K231657).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • Sample Size: Not specified for the cancellous screw testing (Torsional Properties, Driving Torque, Axial Pull-out Strength).
  • Data Provenance: Not specified. The manufacturer is implantcast, GmbH, located in Buxtehude, Germany, but the location where testing was performed is not mentioned. The study is part of a 510(k) submission, generally involving laboratory testing rather than clinical data provenance in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a mechanical shoulder replacement system, and the testing described is mechanical performance (e.g., strength, torque) and biocompatibility, not an AI or diagnostic device that requires expert ground truth for interpretation of medical images or conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is a mechanical shoulder replacement system, not a diagnostic or AI device that requires adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (shoulder replacement system), not an AI-assisted diagnostic tool. No AI component or human reader study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (shoulder replacement system), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical testing of the cancellous screws, the "ground truth" is established by adherence to recognized ASTM standards (ASTM F543) and engineering principles. For biocompatibility, the ground truth is adherence to ISO 10993-1. This is not related to clinical outcomes or expert consensus on pathologies for AI model training.

8. The sample size for the training set

Not applicable. This device is a mechanical shoulder replacement system, not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is a mechanical shoulder replacement system, not an AI/machine learning device.

Summary of what is present:

The document describes the submission of a medical device (AGILON® XO Shoulder Replacement System) for regulatory clearance. The specific focus of this submission (K241944) is the addition of new cancellous screws to an existing system. The performance testing for these screws involved:

  • Engineering analysis.
  • Characterization per ASTM F543 for torsional properties, driving torque, and axial pull-out strength.
  • Biocompatibility evaluation per ISO 10993-1.
  • Leveraging existing data for cleaning, sterilization, packaging, shelf-life, and endotoxin from the predicate device (K231657).

The conclusion is that the testing demonstrated "sufficient performance for the intended use" and "met the predetermined acceptance criteria." However, the specific quantitative values for these criteria and the test results are not detailed in the provided text.

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March 10, 2025

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

implantcast, GmbH % Sarah Pleaugh Director of Regulatory Affairs MCRA, LLC 803 7th Street NW. Floor 3 Washington, District of Columbia 20001

Re: K241944

Trade/Device Name: AGILON® XO Shoulder Replacement System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT, HSD, PHX Dated: February 11, 2025 Received: February 11, 2025

Dear Juliane Hoppner:

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/cdrb/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.

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"

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(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 (QS) 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 OS 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 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.

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 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).

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Sincerely,

Farzana Sharmin -S

Digitally signed by Farzana Sharmin -S Date: 2025.03.10 15:46:21 -04'00'

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

Submission Number (if known)

K241944

Device Name

AGILON® XO Shoulder Replacement System

Indications for Use (Describe)

The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:

  • · Non- inflammatory deqenerative joint disease including osteoarthritis and avascular necrosis,
  • · Post-traumatic osteoarthritis.
  • · Fractures,
  • · Rheumatoid arthritis.

The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:

  • · Multi-fragmental comminuted fractures of the humeral head,
  • · 3- and 4-Fragment-fractures of the proximal humerus,
  • · Head-splitting fractures,
  • · Dislocated head-splitting fractures,
  • · Humeral head depression with more than 40% of joint surface depressed,
  • · Interlocking chronic dislocation with deep HILL-SACHS lesion,
  • · Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening),
  • · Posttraumatic humeral head necrosis,

· Omarthrosis.

AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.

The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:

  • · Rotator cuff tear arthropathy,
  • · Chronic trauma shoulder,

· Decentering of the humeral head after implantation of a humeral head prosthesis.

Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.

In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows:

  • · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
  • · From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
  • · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty

· From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure

· From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure

  • From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
  • · From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty The device is intended for adults.

The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless

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

fixation.

The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The qlenoid cementless is intended for cementless use with the addition of screws for fixation.

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)

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510(k) Summary

Device Trade Name:AGILON® XO Shoulder Replacement System
Manufacturer:implantcast. GmbHLüneburger Schanze 2621614 Buxtehude, Germany
Contact:Juliane Höppner, Director of Regulatory & Clinical & Biological Affairsimplantcast. GmbHOffice: 49-4161-744-135
Prepared by:MCRA, LLC803 7th Street, NW, 3rd FloorWashington, DC 20001Office: 202.552.5800
Date Prepared:July 2, 2024
Classifications:21 CFR 888.3650, Shoulder joint metal/polymer non-constrained cementedprosthesis21 CFR 888.3660, Shoulder joint metal/polymer semi-constrainedcemented prosthesis21CFR 888.3690, Shoulder joint humeral (hemi-shoulder) metallicuncemented prosthesis
Common Name:Shoulder Prosthesis
Class:II
Product Codes:KWT, HSD, PHX
Primary Predicate:AGILON® XO Shoulder Replacement System (K231657)
Additional Predicate:AGILON® XO Shoulder Replacement System (K222482)AGILON® XO Shoulder Replacement System (K191433)

Indications For Use:

The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:

  • · Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
  • Post-traumatic osteoarthritis, .
  • Fractures, .

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

  • . Rheumatoid arthritis.
    The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:

  • Multi-fragmental comminuted fractures of the humeral head, .

  • 3- and 4-Fragment-fractures of the proximal humerus, ●

  • Head-splitting fractures, ●

  • Dislocated head-splitting fractures, ●

  • Humeral head depression with more than 40% of joint surface depressed, ●

  • Interlocking chronic dislocation with deep HILL-SACHS lesion, ●

  • Fracture instability following internal fixation attempt in 3-fragment and 4-fragment fractures (secondary dislocation, material loosening),

  • Posttraumatic humeral head necrosis, ●

  • . Omarthrosis.

AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.

The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:

  • Rotator cuff tear arthropathy, ●
  • Chronic trauma shoulder,
  • Decentering of the humeral head after implantation of a humeral head prosthesis. ●

Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.

In case of revision surgery the available bone stock has to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows:

  • From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty .
  • From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty ●
  • From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty ●
  • From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as ● salvage procedure
  • From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
  • From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder ● Arthroplasty
  • . From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty

The device is intended for adults.

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

The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation.

The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The glenoid cementless is intended for cementless use with the addition of screws for fixation.

Device Description:

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with options depending upon the size and anatomical needs of each patient. The subject submission is for new cancellous screws for use in a total reverse shoulder replacement with the previously cleared K231657 components:

  • Humeral Head Components ●
  • Glenoid and Glenosphere Components ●
  • Humeral Stems and Stem Extension Pieces
  • Metaphyseal Components ●
  • Fixation and Cancellous Screws ●

The subject line extension components are intended for use with previously cleared AGILON XO Shoulder System instruments. There are no changes to packaging, sterility, shelf life, or materials subject to this submission.

Predicate Device:

implantcast submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, AGILON® XO Shoulder Replacement System is substantially equivalent in indications, design principles, and performance to the predicate AGILON® XO Shoulder Replacement System (K231657).

Performance Testing Summary:

Engineering analysis and a review of the previously completed testing of the predicate AGILON XO Shoulder Replacement System demonstrated no new worst-case was created for the system of devices requiring new construct testing. The new cancellous screws were fully characterized per ASTM F543 testing:

  • Torsional Properties ●
  • Driving Torque ●
  • Axial Pull-out Strength ●

The testing demonstrated sufficient performance for the intended use, met the predetermined acceptance criteria, and supports substantial equivalence.

The biocompatibility evaluation was completed per ISO 10993-1.

The cleaning, sterilization, packaging, shelf-life, and endotoxin testing were leveraged from the predicate AGILON® XO Shoulder Replacement System (K231657).

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Substantial Equivalence Conclusion:

The data included in this submission demonstrate substantial equivalence to the predicate device. AGILON® XO Shoulder Replacement System is as safe, as effective, and performs as well as, or better, than the predicate device.

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”