The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Device Description

The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. This device configuration increases the lever arm of the deltoid muscle bundle to provide stability and the ability to raise the arm. This is especially useful in cases where a patient has a non-functioning rotator cuff which severely limits traditional joint replacement options.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Comprehensive® Reverse Shoulder - E1® Polyethylene Claims". It details the device's indications for use, regulatory classification, and claims related to its E1® Antioxidant Infused Technology.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Claim	Reported Device Performance and Test Details
Claim 1: E1® Antioxidant Infused Technology prevents oxidative degradation of polyethylene.	Test: Environmental Stress Cracking Testing. Cyclically loaded GUR1020 and GUR1050 E1® test specimens in an air atmosphere at 80°C for 5 weeks. Testing per Nabar, Sean, et al. Transactions of the 54th Annual Meeting of the ORS, Poster No. 1684. Performance: E1® specimens showed no evidence of environmental stress cracking. Infrared spectroscopy showed no detectable oxidation in loaded or unloaded samples (oxidation indices <0.1).
Claim 2: E1® Antioxidant Infused Technology protects polyethylene from oxidation and cracking during environmental stress crack testing. (Comparative)	Test: Comparative Environmental Stress Cracking Testing. Cyclically loaded test specimens in an air atmosphere at 80°C for 5 weeks per Nabar, Sean, et al. - GUR1050 E1® against: GUR1050 gamma sterilized (25-40kGy in argon) polyethylene AND sequentially crosslinked and annealed polyethylene (GUR 1050 barstock, 33kGy gamma irradiated in air, annealed at 130°C in air, repeated for total 99kGy, then machined). - GUR1020 E1® against: GUR1050 direct compression molded polyethylene gamma sterilized (25-40kGy) in argon. Performance: E1® material was the only material tested that showed no evidence of environmental stress cracking or fracture and no detectable oxidation (indices <0.1). Both gamma sterilized and sequentially crosslinked and annealed polyethylene showed evidence of increased oxidation and cracking or fracture.
Claim 3: E1® Antioxidant Infused Technology maintains the mechanical strength of conventional UHMWPE under small punch testing. (Comparative)	Test: Small Punch Testing per ASTM F2183. - E1® GUR1050 material compared to GUR1050 gamma sterilized in argon isostatic compression molded (ICM) UHMWPE. - E1® GUR1020 material compared to GUR1050 gamma sterilized (25-40kGy) in argon direct compression molded (DCM) UHMWPE. Performance: - E1® GUR1050 ultimate load: 105 ± 5.5N. GUR1050 ICM control ultimate load: 75.4 ± 5.3N. (p<0.001) - E1® GUR1050 ultimate load: 97.2 ± 6.4N. DCM control ultimate load: 86.6 ± 7.5N. (p<0.001) E1® materials had statistically significantly greater ultimate loads than the respective controls.
Claim 4: E1® Antioxidant Infused Technology maintains mechanical strength after accelerated aging.	Test: Accelerated aging per ASTM F2003 (70°C and 5 atm of oxygen for 14 days). Followed by small punch testing per ASTM F2183 (for ultimate load) and tensile testing per ASTM D638 (for ultimate tensile strength and yield strength). Performance: No significant decrease (P>0.05) in ultimate load, ultimate tensile strength, or yield strength after accelerated aging for either E1® GUR1050 or E1® GUR1020 material. - E1® GUR1020: Ultimate load (before/after aging) 97.2±6.4N / 100.0±5.0N. Ultimate tensile strength 45.8±1.6 MPa / 46.1±2.9 MPa. Yield strength 22.6±0.2 MPa / 22.8±0.3 MPa. - E1® GUR1050: Ultimate load (before/after aging) 105.0±5.5N / 115.0±3.2N. Ultimate tensile strength 43±3 MPa / 43±2 MPa. Yield strength 24.2±0.2 MPa / 24.4±0.2 MPa.

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

The document describes material testing, not patient-level data. The "test sets" refer to the numbers of material specimens or samples used in the mechanical and chemical tests.

Sample Size: Not explicitly stated as a single number. For Claim 3, ultimate loads are given with standard deviations (e.g., 105±5.5N), implying multiple samples were tested for each group, but the exact number of replicates is not provided. Similarly for Claim 4, multiple samples are implied. For Claims 1 and 2, it refers to "specimens" without numerical counts.
Data Provenance: Not applicable in the context of patient data. The tests are bench tests conducted on materials. The "provenance" refers to the specific materials (GUR1020 and GUR1050 UHMWPE) and their processing methods (isostatically compression molded, crosslinked, gamma irradiation, vitamin E infusion, etc.). It's a laboratory-based study.
Retrospective/Prospective: Not applicable. These are in-vitro, bench-top material tests.

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

Not applicable. This document details material properties and performance through standardized mechanical and chemical testing, not expert interpretation of clinical data. The "ground truth" is established by the results of these physical tests, which are objective measurements.

4. Adjudication Method for the Test Set

Not applicable. This refers to consensus-building among experts for ambiguous cases in clinical studies. For material performance tests, observations (like presence/absence of cracks, oxidation indices, ultimate load measurements) are objective and do not require expert adjudication to establish truth.

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 material science study to evaluate the properties of polyethylene used in a shoulder prosthesis, not an AI-based diagnostic or assistive device. There are no human readers or AI involved in interpreting the results.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a material science study, not an algorithm or AI performance evaluation.

7. The Type of Ground Truth Used

The ground truth is established by objective measurements and observations from validated laboratory tests on material samples. Examples include:

Absence of environmental stress cracking (visual inspection/microscopy).
Oxidation indices from infrared spectroscopy (quantitative chemical analysis).
Ultimate load measurements from small punch testing (quantitative mechanical test).
Ultimate tensile strength and yield strength from tensile testing (quantitative mechanical test).

These are direct physical and chemical properties of the material, measured using established scientific methods, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in these material performance studies. The tests are conducted on representative samples of the manufactured material to evaluate its inherent properties.

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

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 2, 2016

Biomet Manufacturing Corporation Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46580

Re: K121183

Trade/Device Name: Comprehensive® Reverse Shoulder - E1® Polyethylene Claims Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, PAO, KWS Dated: April 13, 2012 Received: May 8, 2012

Dear Ms. Beres:

This letter corrects our substantially equivalent letter of July 26, 2012.

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. 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 801); medical device reporting (reporting of medical

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Page 2 - Ms. Patricia Sandborn Beres

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use ·

KIZII! 510(k) Number (if known):

Device Name: Comprehensive® Reverse Shoulder - E1® Polyethylene Claims

Indications For Use:

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Asif

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121183

Page 1 of 1

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JUL 26 2012

Image /page/3/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The logo is a stylized version of the word "BIOMET" with the letters connected and enclosed in a rectangular border. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The number K121183 is written in the upper right corner.

510(k) SUMMARY

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

SUBMITTER INFORMATION
Name	Biomet Manufacturing Corp.
Address	56 East Bell DriveWarsaw, IN 46582
Phone number	(574) 267-6639
Fax number	(574) 371-1027
Establishment	1825034
Registration Number
Name of contact person	Patricia Sandborn BeresSenior Regulatory SpecialistBiomet Manufacturing Corp.
Date prepared	June 14, 2012
NAME OF DEVICE
Trade or proprietaryname	Comprehensive® Reverse Shoulder - E1® Polyethylene Claims
Common or usual name	Shoulder Prosthesis
Classification name	Shoulder joint, metal/polymer, semi-constrained, cementedprosthesis
Classification panel	Orthopedics
Regulation	21 CFR 888.3660
Product Code(s)	KWS, PAO
Legally marketeddevice(s) to whichequivalence is claimed	Comprehensive® Reverse Shoulder System - K080642Comp. Reverse Shoulder - E1® Humeral Bearings - K113121
Reason for 510(k)submission	Claims language .
Device description	The Comprehensive® Reverse Shoulder is intended for totalshoulder replacement in a reverse shoulder configuration. Unliketraditional total shoulder replacement, a reverse shoulder employs aball for articulation on the glenoid side of the joint and apolyethylene bearing surface on the humeral side of the joint. Thisdevice configuration increases the lever arm of the deltoid musclebundle to provide stability and the ability to raise the arm. This isespecially useful in cases where a patient has a non-functioningrotator cuff which severely limits traditional joint replacementoptions.
Intended use of thedevice	Shoulder Replacement
Indications for use	The Comprehensive® Reverse Shoulder is indicated for use inpatients whose shoulder joint has a grossly deficient rotator cuffwith severe arthropathy and/or previously failed shoulder jointreplacement with a grossly deficient rotator cuff. The patient mustbe anatomically and structurally suited to receive the implantsand a functional deltoid muscle is necessary.The Comprehensive® Reverse Shoulder is indicated for primary,fracture, or revision total shoulder replacement for the relief ofpain and significant disability due to gross rotator cuff deficiency.Glenoid components with Hydroxyapatite (HA) coating applied overthe porous coating are indicated only for uncemented biologicalfixation applications. The Glenoid Baseplate components areintended for cementless application with the addition of screwfixation.Interlok® finish humeral stems are intended for cemented use andthe MacroBond® coated humeral stems are intended for press-fit orcemented applications. Humeral components with porous coatedsurface coating are indicated for either cemented or uncementedbiological fixation applications.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE HUMERAL BEARINGCOMPARED TO THE PREDICATE
The devices contained in this 510(k) are identical in material, dimensions, and attachment methodsto the devices contained in the predicate Comprehensive® Reverse Shoulder System 510(k)submissions, K080642 and K113121
PERFORMANCE DATA
Summary Of Non-Clinical Tests Conducted For Determination Of Substantial Equivalence
Environmental Stress Cracking Testing
Small punch Testing
Tensile Testing per ASTM F648
Summary of Clinical Tests Conducted for Determination of Substantial Equivalenceand/or of Clinical Information
No clinical data submitted
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
No clinical data was necessary for a determination of substantial equivalence.
The results of testing indicated the material performed within the intended use, did not raise any new.safety and efficacy issues and were found to be substantially equivalent to the predicate devices.

Matiing Address:
P.O. Box 5B7
Warbaw, IN 4E551-0587 Tod Fred: 800.346.9500 0:00:00:574.207.6639
Max Fax: 574.267.8137
www.biomst.com Shipping Addross: 53 East Bell Drivo Via:saw, IN 46582

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K121183

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K12-1183

CLAIMS FOR E1® ANTIOXIDANT INFUSED TECHNOLOGY*

Claim 1:

E1® Antioxidant Infused Technology prevents oxidative degradation of polyethylene. Environmental stress crack testing was conducted by cyclically loading GUR1020 and GUR1050 E1® test specimens in an air atmosphere maintained at 80℃ for 5 weeks. Testing was completed per the literature (Nabar, Sean, et al. Transactions of the 54th Annual Meeting of the ORS, Poster No. 1684). E1® specimens showed no evidence of environmental stress cracking and infrared spectroscopy showed no detectable oxidation in the loaded or unloaded samples (oxidation indices <0.1). E1® samples were machined from either GUR1020 or GUR1050 isostatically compression molded UHMWPE crosslinked with 100 kGy gamma irradiation under argon, doped with atocopherol, and subsequently gamma sterilized (25-40 kGy) in Argon. Bench testing is not necessarily indicative of clinical performance.

Claim 2:

E1® Antioxidant Infused Technology protects polyethylene from oxidation and cracking during environmental stress crack testing. Environmental stress crack testing was conducted by cyclically loading test specimens in an air atmosphere maintained at 80°C for 5 weeks per the literature (Nabar, Sean, et al. Transactions of the 540 Annual Meeting of the ORS, Poster No. 1684). GUR1050 E1® specimens ran head to head with GUR1050 gamma sterilized (25-40kGy in argon) polyethylene and sequentially crosslinked and annealed polyethylene (GUR 1050 barstock, 33kGy gamma irradiated in air, annealed at 130C in air and repeated for a total dose of 99kGy and machined into final part geometry). GUR1020 E1® specimens ran head to head with GUR1050 direct compression molded polyethylene that was gamma sterilized (25-40kGy) in argon. The E1® material was the only material tested that showed no evidence of environmental stress cracking or fracture and no detectable oxidation indices <0.1) in the loaded and unloaded samples using infrared spectroscopy. Both gamma sterilized and sequentially crosslinked and annealed polyethylene showed evidence of increased oxidation and cracking or fracture during environmental stress crack testing. E1® samples were machined from either GUR1020 or GUR1050 isostatically compression molded UHMWPE, crosslinked with 100 kGy gamma irradiation under argon, infused with vitamin E, and subsequently gamma sterilized (25-40 kGy) in Argon. Bench testing is not necessarily indicative of clinical performance.

Claim 3: '

E1® Antioxidant Infused Technology maintains the mechanical strength of conventional UHMWPE under small punch testing. Small punch testing per ASTM F2183 was conducted for the E1® GUR1050 material and the E1® GUR1020 material. The E1® GUR1050 material was compared to GUR1050 gamma sterilized in argon isostatic compression molded (ICM) UHMWPE and the E1® GUR1020 material was compared to GUR1050 gamma sterilized (25-40kGy) in argon direct compression molded (DCM) UHMWPE. The ultimate load for the E1® GUR1050 material and the GUR1050 ICM

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K.1211.83

material are 105±5.5N and 75.4±5.3N respectively. The ultimate load for the E1® GUR1050 material and the DCM control material are 97.2±6.4N and 86.6±7.5N respectively. The E1® materials had ultimate loads greater than that of the ICM and DCM control. These differences were statistically significant (p<0.001 for all comparisons). E1® samples were machined from either GUR1020 or GUR1050 ICM UHMWPE, crosslinked with 100 kGy gamma irradiation under argon, infused with vitamin E, and subsequently gamma sterilized (25-40 kGy) in Argon. Bench testing is not necessarily indicative of clinical performance.

Claim 4 :

E1® Antioxidant Infused Technology maintains mechanical strength after accelerated aging. There was no significant decrease (P>0.05) in ultimate load , ultimate tensile strength, or yield strength after accelerated aging for either the E1® GUR1050 or the E1® GUR1020 material. Ultimate load was measured by small punch testing per ASTM F2183; ultimate tensile strength and yield strength were measured by tensile testing per ASTM D638; Accelerated aging was performed per ASTM F2003 (70°C and 5 atm of oxygen for 14 days). The ultimate load for the E1® GUR1020 material before and after accelerated aging was 97.2±6.4N and 100.0±5.0N respectively. The ultimate tensile strength for the E1® GUR1020 material before and after accelerated aging was 45.8±1.6 and 46.1±2.9 MPa respectively. The yield strength for the E1® GUR1020 material before and after accelerated aging was 22.6±0.2 and 22.8±0.3 MPa respectively. The ultimate load for the E1® GUR1050 material before and after accelerated aging was 105.0±5.5N and 115.0±3.2N respectively. The ultimate tensile strength for the E1® GUR1050 material before and after accelerated aging was 43±3 and 43±2 MPa respectively. The vield strength for the E1® GUR1050 material before and after accelerated aging was 24.2±0.2 and 24.4±0.2 MPa respectively. E1® samples were machined from either GUR1020 or GUR1050 isostatically compression molded UHMWPE, crosslinked with 100 kGy gamma irradiation under argon, infused with vitamin E, and subsequently gamma sterilized (25-40 kGy) in Argon. Bench testing is not necessarily indicative of clinical performance.

Note: E10 Antioxidant Infused Technology may be used interchangeably with any of the following: E19 Antioxidant Infused Bearings, E10 Antioxidant Infused Material, E10 material, E1® technology, E1® bearings, E1® liners, E1® acetabular liners, E1° Humeral Bearings and E1®

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.”