A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
Irreducible 3- and 4-part fractures of the proximal humerus
Ununited humeral head fractures
Avascular necrosis of the humeral head
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)

Hemi-shoulder arthroplasty is also indicated for:

Deformity and/or limited motion

The GLOBAL UNITE Reverse Fracture Epiphyseal Component, in conjunction with components from the existing DELTA XTEND™ Reverse Shoulder System and GLOBAL UNITE Platform Shoulder System, is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. It is intended for cemented reverse shoulder arthroplasty in treatment of the following:

Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
Irreducible 3- and 4-part fractures of the proximal humerus
Ununited humeral head fractures

The GLOBAL UNITE Reverse Fracture Epiphyseal Component is only intended for use in the treatment of proximal humeral fractures. Bone preparation instrumentation has not been validated to accommodate its use in a non-fracture press-fit application.

GLOBAL UNITE Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint must be anatomically and structurally suited to receive the reverse implant(s), and a functional deltoid muscle is necessary to use the device.

When used in a total shoulder arthroplasty, the GLOBAL UNITE Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.

When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. GLOBAL UNITE humeral implants are for cemented use. The DELTA XTEND epiphyseal components are HA-coated and are intended for uncemented use.

Device Description

The subject device expands the GLOBAL UNITE Platform Shoulder System (K101996, K133834) to include new porous-coated reverse fracture epiphyseal bodies made from titanium alloy that mate with existing GLOBAL UNITE (K101996) or DELTA XTEND (K071379) stems. In fracture cases with a grossly rotator cuff deficient glenohumeral joint with severe arthropathy where a surgeon deems reverse shoulder arthroplasty appropriate, the surgeon can use a GLOBAL UNITE (K101996) or DELTA XTEND (K071379) stem with the GLOBAL UNITE reverse fracture epiphysis and the DELTA XTEND metaglene and glenosphere (K062250).

AI/ML Overview

The provided text is a 510(k) Summary for the GLOBAL UNITE Platform Shoulder System. It details non-clinical tests performed to demonstrate substantial equivalence to predicate devices, but explicitly states that no clinical testing was conducted. Therefore, it is not possible to describe acceptance criteria and a study proving a device meets them in the traditional sense of clinical performance or diagnostic accuracy.

However, I can extract the information related to the non-clinical acceptance criteria and the studies that demonstrate compliance with those engineering and material performance requirements.

Here's the information based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Since this is a non-clinical submission, the "acceptance criteria" are implied by the nature of the tests (e.g., passing a fatigue test, demonstrating biocompatibility according to standards). The "reported device performance" is summarized as the device meeting these requirements to demonstrate substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
- Fracture stem with fracture epiphysis (high torque) - Fatigue Resistance	Met requirements (demonstrated substantial equivalence)
- Fracture stem with fracture epiphysis (low torque) - Fatigue Resistance	Met requirements (demonstrated substantial equivalence)
Fretting Corrosion Potential	Comparable to existing product
Epiphysis Comparison	Met requirements (demonstrated substantial equivalence)
135° Neck Shaft Angle Verification	Verified compatibility
128° and 142° Neck Shaft Angle Verification	Verified compatibility
Range of Motion Analysis	Met requirements (demonstrated substantial equivalence)
Rationale for 155 Degree Neck-Shaft Angle	Provided rationale
Biocompatibility:
Biocompatibility Standards	Met requirements (demonstrated substantial equivalence)
Design/Manufacturing:
Mating Parts Analysis	Performed (demonstrated substantial equivalence)
Effect of Screw Retention Insert on Humeral Cup Seating	Evaluated (demonstrated substantial equivalence)
Print Review of Product Marking	Reviewed for compliance
Print Review of Suture Features	Reviewed for compliance
Review of Label Content	Reviewed for compliance
Print Review of Porocoat	Reviewed for compliance
Sterilization:
Bacterial Endotoxin Testing (ANSI AAMI ST-72:2011)	Met the requirement

2. Sample size used for the test set and the data provenance:

Sample size: Not specified in the provided text. For non-clinical tests like fatigue or biocompatibility, samples would typically refer to the number of physical devices or components tested. The exact number is not detailed here.
Data provenance: The tests were performed on the GLOBAL UNITE Shoulder System by DePuy Orthopaedics. Given the context of a 510(k) submission to the FDA in the US, the testing would typically be conducted under recognized standards, likely in a controlled laboratory environment. The origin of the data is from these internal and external laboratory tests, not from patient data from a specific country. The study explicitly states "No clinical testing was conducted." The tests are non-clinical in nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not applicable. For non-clinical (e.g., mechanical, materials, biocompatibility) testing, "ground truth" is established by adherence to recognized engineering standards and measurement techniques, not by expert consensus on clinical findings.
Qualifications of experts: Not applicable in the context of clinical ground truth establishment. The scientists and engineers performing and interpreting these technical tests would be qualified in their respective fields (e.g., mechanical engineering, materials science, toxicology).

4. Adjudication method for the test set:

Adjudication method: Not applicable. This concept (e.g., 2+1, 3+1) is relevant for clinical studies where multiple human readers assess data and discrepancies need to be resolved. For non-clinical engineering and material tests, compliance is determined by meeting predetermined specifications and standards.

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:

MRMC study: No. This is not applicable as the device is a shoulder implant and the submission is for non-clinical testing to demonstrate substantial equivalence, not for an AI/CADe system.

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

Standalone study: No. This is not applicable as the device is a shoulder implant, not a software algorithm.

7. The type of ground truth used:

Type of ground truth: Not applicable in the clinical or diagnostic sense for this submission. For these non-clinical tests, the "ground truth" is established by:
- Engineering specifications and standards: e.g., ASTM standards for mechanical testing, ISO standards for biocompatibility.
- Reference materials: For comparative tests like fretting corrosion.
- Pre-defined pass/fail criteria: Based on these standards and specifications.

8. The sample size for the training set:

Sample size for training set: Not applicable. The device is a physical medical implant, not an AI or machine learning algorithm that requires a training set.

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

Ground truth for training set: Not applicable (see point 8).

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 11, 2018

DePuy Ireland UC % Kellie Myers Regulatory Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Dr. Warsaw, Indiana 46582

Re: K170748

Trade/Device Name: GLOBAL UNITE Platform Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, HSD Dated: January 3, 2018 Received: January 4, 2018

Dear Kellie Myers:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -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

510(k) Number (if known) K170748

Device Name

GLOBAL UNITE Platform Shoulder System

Indications for Use (Describe)

The GLOBAL UNITE Platform Shoulder System is intended for cemented total or hemi-shoulder arthroplasty in treatment of the following:

· A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or
rheumatoid arthritis
· Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
· Irreducible 3- and 4-part fractures of the proximal humerus
· Ununited humeral head fractures
· Avascular necrosis of the humeral head

· Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)

Hemi-shoulder arthroplasty is also indicated for:

· Deformity and/or limited motion
The GLOBAL UNITE Reverse Fracture Epiphyseal Component, in conjunction with components from the existing DELTA XTEND™ Reverse Shoulder System and GLOBAL UNITE Platform Shoulder System, is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. It is intended for cemented reverse shoulder arthroplasty in treatment of the following:

· Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory

· Irreducible 3- and 4-part fractures of the proximal humerus
· Ununited humeral head fractures

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only. GLOBAL UNITE humeral implants are for cemented use. The DELTA XTEND epiphyseal components are HA-coated and are intended for uncemented use.

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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510(K) SUMMARY

(As required by 21 CFR 807.92 and 21 CFR 807.93)

Submitter Information
Name	DePuy Orthopaedics
Address	700 Orthopedic DriveWarsaw, IN 46582
Phone number	574-372-7276
Fax number	574- 371-4987
Establishment RegistrationNumber	1818910
Name of contact person	Kellie Myers
Date prepared	11 January 2018
Name of device
Trade or proprietary name	GLOBAL UNITE Platform Shoulder System
Common or usual name	Total, Hemi-, and Reverse Shoulder Arthoplasty Prosthesis
Classification name	Shoulder joint metal/polymer semi-constrained cemented prosthesis;Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	21 CFR 888.3660; 21 CFR 888.3690
Product Code(s)	PHX; KWS; HSD
Legally marketed device(s) towhich equivalence is claimed	Zimmer Trabecular Metal® Reverse Shoulder System, K052906;Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and10mm, K060704DePuy GLOBAL UNITE Shoulder System, K101996DePuy GLOBAL UNITE Shoulder System, K133834
Reason for 510(k) submission	This 510(k) submission is to add the GLOBAL UNITE Reverse FractureEpiphysis to the currently cleared GLOBAL UNITE Platform ShoulderSystem, as well as to expand the currently cleared Indications for Use for theentire GLOBAL UNITE Platform Shoulder System.
Device description	The subject device expands the GLOBAL UNITE Platform Shoulder System(K101996, K133834) to include new porous-coated reverse fractureepiphyseal bodies made from titanium alloy that mate with existing GLOBALUNITE (K101996) or DELTA XTEND (K071379) stems. In fracture caseswith a grossly rotator cuff deficient glenohumeral joint with severe arthropathywhere a surgeon deems reverse shoulder arthroplasty appropriate, the surgeoncan use a GLOBAL UNITE (K101996) or DELTA XTEND (K071379) stem
	with the GLOBAL UNITE reverse fracture epiphysis and the DELTA XTEND
	metaglene and glenosphere (K062250).
Intended use of the device	Cemented or uncemented Total, Hemi-, or Reverse Shoulder Arthroplasty
Indications for use	The GLOBAL UNITE Platform Shoulder System is intended for cementedor uncemented total or hemi-shoulder arthroplasty in treatment of the following:A severely painful and/or disabled joint resulting fromosteoarthritis, traumatic arthritis or rheumatoid arthritis Fracture of the proximal humerus where the articular surface isseverely comminuted, separated from its blood supply or where thesurgeon's experience indicates that alternative methods of treatmentare unsatisfactory Irreducible 3- and 4-part fractures of the proximal humerus Ununited humeral head fractures Avascular necrosis of the humeral head Other difficult clinical problems where shoulder arthrodesis orresection arthroplasty are not acceptable (e.g. revision of a failedprimary component)
	Hemi-shoulder arthroplasty is also indicated for:Deformity and/or limited motion
	The GLOBAL UNITE Reverse Fracture Epiphyseal Component, inconjunction with components from the existing DELTA XTEND™ ReverseShoulder System and GLOBAL UNITE Platform Shoulder System, isindicated for use in a grossly rotator cuff deficient glenohumeral joint withsevere arthropathy or a previously failed joint replacement with a grossrotator cuff deficiency. The patient's joint must be anatomically andstructurally suited to receive the selected implant(s), and a functional deltoidmuscle is necessary to use the device. It is intended for cemented oruncemented reverse shoulder arthroplasty in treatment of the following:Fracture of the proximal humerus where the articular surface isseverely comminuted, separated from its blood supply or where thesurgeon's experience indicates that alternative methods of treatmentare unsatisfactory Irreducible 3- and 4-part fractures of the proximal humerus Ununited humeral head fractures
	The GLOBAL UNITE Reverse Fracture Epiphyseal Component is onlyintended for use in the treatment of proximal humeral fractures. Bone

preparation instrumentation has not been validated to accommodate its use in
a non-fracture press-fit application.
GLOBAL UNITE Humeral Stems, in conjunction with existing DELTAXTEND Epiphyseal Components, are indicated for use in reverse shoulderarthroplasty in treatment of a grossly deficient rotator cuff joint with severearthropathy or a previously failed joint replacement with a grossly deficientrotator cuff joint. The patient's joint must be anatomically and structurallysuited to receive the reverse implant(s), and a functional deltoid muscle isnecessary to use the device.
When used in a total shoulder arthroplasty, the GLOBAL UNITE Implantsare to be used with DePuy glenoid components. The glenoid components arefor cemented use only. GLOBAL UNITE Humeral Implants are forcemented or uncemented use.
When used in a reverse shoulder arthroplasty, the GLOBAL UNITE andDELTA XTEND Humeral Implants are to be used with the HA-coatedDELTA XTEND Metaglene Devices. The metaglene implants are intendedfor uncemented use only with additional screw fixation. The HA-coatedDELTA XTEND Humeral Implants are intended for uncemented use only.GLOBAL UNITE humeral implants are for cemented or uncementeduse. The DELTA XTEND epiphyseal components are HA-coated and areintended for uncemented use.

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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

The subject GLOBAL UNITE Platform Shoulder System is similar to the predicate Zimmer Trabecular Metal Reverse Shoulder System (K052906, K060704) and the predicate DePuy GLOBAL UNITE Shoulder System (K101996, 133834) in intended use, design, material, and fixation. The subject and predicate systems are intended for total, hemi-, or reverse shoulder arthroplasty; have modular anatomic/reverse convertibility; are made of titanium alloy; are intended for cemented or uncemented use; and include similar tissue reattachment options such as suture holes and suture collars. Differences include the type of modularity and fixation-the subject device and the predicate GLOBAL UNITE Shoulder System (K101996, 133834) are a modular stemepiphysis design, while the predicate Zimmer Trabecular Metal Reverse Shoulder (K052906, K060704) is a monobloc stem with a dual taper adapter for the anatomic configuration. The subject device and the predicate GLOBAL UNITE Shoulder System (K101996, 133834) also use Porocoat® titanium porous coating for biological fixation, while the predicate Zimmer Trabecular Metal Reverse Shoulder (K052906, K060704) uses porous tantalum.

PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The following tests were performed (per FDA's Guidance for Industry and FDA Staff – Class II Special Controls Guidance: Shoulder Joint Metal Nonconstrained or Semi-Constrained Porous-Coated

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Uncemented Prosthesis) on the GLOBAL UNITE Shoulder System to demonstrate substantial equivalence of safety and efficacy with the predicate device:

Fatigue Test for fracture stem with fracture epiphysis (at higher assembly torque) .
Fatigue Test for fracture stem with fracture epiphysis (at lower assembly torque)
Fretting Corrosion Potential - Comparison to Existing Product
Epiphysis Comparison
135° Neck Shaft Angle Verification
. 128° and 142° Neck Shaft Angle Verification
Range of Motion Analysis ●
. Rationale for 155 Degree Neck-Shaft Angle
Biocompatibility Study
. Mating Parts Analysis
Effect of Screw Retention Insert of the Implant Packaging on Humeral Cup Seating
Print Review of Product Marking
Print Review of Suture Features
. Review of Label Content
Print Review of Porocoat
. The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011.

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

No clinical testing was conducted to demonstrate substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The subject DePuy Synthes GLOBAL UNITE Shoulder System is substantially equivalent to the predicates Zimmer Trabecular Metal Reverse Shoulder System (K052906) and Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm (K060704).

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.”