The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The AEQUALIS FLEX REVIVE Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The AEQUALIS FLEX REVIVE Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

Rheumatoid arthritis with pain
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Revision of other devices if sufficient bone stock remains

IN REVERSE:

The AEQUALIS FLEX REVIVE Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle 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
· Massive and non-repairable rotator cuff tear
· Revision of the devices if sufficient bone stock remains

The reversed tray and polyethylene insert are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle.

Notes:

All components are single use.
· The coated humeral stem is intended for cemented or cementless use.
· The all-poly glenoid components are intended for cemented use only
· The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
Titanium humeral heads are intents with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

Device Description

AEQUALIS FLEX REVIVE Shoulder System (AFR) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation. AFR includes a proximal body (metaphysis), spacer(s), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Ascend Flex Humeral Head and Ascend Flex reversed trays and poly inserts.

The AFR Shoulder System is implanted by a surgeon and is designed to allow the surgeon to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Ascend Flex humeral heads or Ascend Flex reversed trays and inserts. In addition, the AFR Shoulder System can be transformed from anatomic to reverse shoulder prosthesis without the removal of the humeral implant assembly during revision surgery.

The humeral length is measured to determine the overall humeral implant construct length. The length is assembled from 120 mm (using the short proximal body and stem) to 180 mm (using the standard proximal body, spacers, and stem) in 10mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity.

The proximal body, stem, and spacers are made from Ti6Al4V per ASTM F-136. The proximal body and stem have a Titanium plasma coating. The assembly screw and locking cap are made from of CoCr per ISO 5832-121. They are single use and packaged sterile, using gamma radiation at a minimum dose of 25 KGy to an SAL of 1x10-6.

AI/ML Overview

The provided text describes the AEQUALIS FLEX REVIVE Shoulder System, a medical device, and summarizes the non-clinical performance testing conducted to support its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Performed	Acceptance Criteria	Reported Device Performance and Conclusion
Fatigue Testing	The humeral stems were tested to 10 million cycles (5 million in each configuration) without failure, fracture, or dislocation when inspected after each tested configuration at a magnification of 50X.	Met acceptance criteria. Tested without failure, fracture, or dislocation.
Range of Motion	The Aequalis Flex Revive Shoulder System met the range of motion requirements in ASTM F1378-12.	Met acceptance criteria.
Taper Tensile	Taper resultant force were not significantly lower than those of the Ascend Flex taper connections when analyzed with a 2-sample T-test.	Met acceptance criteria. Taper resultant force was not significantly lower than predicate.
Tensile Static Torque	The disassociation torque of the male taper from the female taper was not statistically lower than 1.72Nm, or two times the anticipated frictional torque between glenoid sphere and the reversed insert.	Met acceptance criteria. Disassociation torque was not statistically lower than specified value.
Press Fit Preparation	The AFR Shoulder System achieved a press-fit for the proximal body and distal stem allowing the implant to attain proper seating and acceptable fixation.	Met acceptance criteria. Achieved proper seating and acceptable fixation.
Cemented Preparation	The AFR Humeral Stem cement mantle thickness met or exceeded the Ascend Flex cement mantle thickness.	Met acceptance criteria. Cement mantle thickness met or exceeded predicate.
Biocompatibility	Biocompatibility requirements per ISO 10993-1 were met.	Met acceptance criteria.
Endotoxin	Endotoxin results per ST72 demonstrated <20EU/device.	Met acceptance criteria.
Packaging	Distribution testing met requirements per ASTM D4169-16.	Met acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

The document summarizes non-clinical performance testing which typically involves bench testing of mechanical properties and material characteristics, not clinical studies with patient data. Therefore, the concepts of "test set sample size" and "data provenance (e.g., country of origin, retrospective/prospective)" as they relate to clinical data are not applicable here. The tests are performed on manufactured device components.

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

Not applicable. Ground truth for mechanical and material tests is established by engineering specifications, recognized standards (ASTM, ISO), and analytical methods, not by expert consensus from clinical professionals for individual test cases.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for reconciling discrepancies in expert opinions on patient data. For non-clinical performance testing, compliance with predetermined acceptance criteria against recognized standards is the primary method of evaluation.

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 submission for a shoulder implant system, not an AI-powered diagnostic or assistive device for human readers.

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

Not applicable. This is a physical medical device (shoulder implant), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical performance testing and acceptance criteria is based on:

Recognized Industry Standards: ASTM (e.g., F1378-12, D4169-16), ISO (e.g., 10993-1, 5832-121).
Internal Engineering Specifications: Derived from device design, intended use, and comparison to predicate devices (e.g., specific torque values, cement mantle thickness targets).
Comparative Analysis to Predicate Devices: Demonstrating that the new device's performance is not significantly inferior to that of a legally marketed predicate device.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense. The "training" for the device's design and manufacturing would involve engineering principles, materials science, and previous product development experience.

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

Not applicable. See point 8.

Summary

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September 20, 2018

Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. 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 letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Tornier, Inc. Laurie Lewandowski Regulatory Associate, Consultant 10801 Nesbitt Ave South Bloomington, Minnesota 55437

Re: K181420

Trade/Device Name: Aequalis Flex Revive Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS, PHX, HSD Dated: August 30, 2018 Received: August 31, 2018

Dear Laurie Lewandowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination. product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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/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,

Vesa	Digitally signed by Vesa Vuniqi -S
Vuniqi -S	Date: 2018.09.20
	16:24:14 -04'00'

Mark N. Melkerson For: 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)

K181420

Device Name Aequalis Flex Revive Shoulder System

Indications for Use (Describe) IN ANATOMIC:

Rheumatoid arthritis with pain
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Revision of other devices if sufficient bone stock remains

IN REVERSE:

The AEQUALIS FLEX REVIVE Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle 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
· Massive and non-repairable rotator cuff tear
· Revision of the devices if sufficient bone stock remains

Notes:

All components are single use.
· The coated humeral stem is intended for cemented or cementless use.
· The all-poly glenoid components are intended for cemented use only
· The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.

· Titanium humeral heads are intents with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

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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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Image /page/4/Picture/0 description: The image shows the word "TORNIER" in a blue serif font, followed by a blue hexagon containing a stylized letter "T" inside. The letter "T" in the hexagon is also in a blue serif font and has a smaller hexagon inside of it. The logo is simple and clean, with a focus on the company name and a unique symbol.

Date Prepared: May 30, 2018

Administrative Information

Name:	Tornier, Inc.
Address:	10801 Nesbitt Avenue SouthBloomington, MN 55437United States of America
Contact Person:	Laurie Lewandowski
Title:	Regulatory Associate, Contract
Phone:	612-770-4038
Fax:	952-426-7601

Device Information

Name of Device: AEQUALIS FLEX REVIVE Shoulder System Common Name (s): Classification Name: Prosthesis, Shoulder, Semi-Constrained, Metal/ Polymer Cemented Regulatory Class: II Regulation Number: 888.3660, 888.3690 Product Code: KWS, PHX, HSD

Predicate Device Information

Predicate Device:	Aequalis Ascend Flex Shoulder System
510K number:	K140082
Reference Device:	Aequalis Adjustable Reversed Shoulder System
510K Number:	K141029

Device Description

Tornier AEQUALIS FLEX REVIVE Shoulder System

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Image /page/5/Picture/0 description: The image shows the word "TORNIER" in large, blue, serif font. To the right of the word is a blue hexagon with a stylized letter "T" inside. The letter "T" is also blue and has a smaller hexagon inside of it.

The AFR Shoulder System is comprised of the component in Table 5.1.

Catalog #	Description	Diameter (mm)	Effective Length (mm)	Angle (°)
Proximal Body
ARS741701	Proximal Body	Ø9	40	132.5
ARS741702	Proximal Body	Ø11	40	132.5
ARS741703	Proximal Body	Ø13	40	132.5
ARS741704	Proximal Body	Ø15	40	132.5
ARS741705	Proximal Body	Ø17	40	132.5
ARS741706	Proximal Body	Ø19	40	132.5
ARS741707	Short Proximal Body	Ø9	30	132.5
ARS741708	Short Proximal Body	Ø11	30	132.5
ARS741709	Short Proximal Body	Ø13	30	132.5
ARS741710	Short Proximal Body	Ø15	30	132.5
ARS741711	Short Proximal Body	Ø17	30	132.5
ARS741712	Short Proximal Body	Ø19	30	132.5
Spacers
Catalog #	Description	Size (diam. and length mm)
ARS342001	Spacer	Ø9 x 20
ARS342002	Spacer	Ø11 x 20
ARS342003	Spacer	Ø13 x 20
ARS342004	Spacer	Ø15 x 20
ARS342005	Spacer	Ø17 x 20
ARS342006	Spacer	Ø19 x 20
ARS342007	Spacer	Ø9 x 30
ARS342008	Spacer	Ø11 x 30
ARS342009	Spacer	Ø13 x 30
ARS342010	Spacer	Ø15 x 30
ARS342011	Spacer	Ø17 x 30
ARS342012	Spacer	Ø19 x 30

Table 5. 1 AFR Shoulder System Components

Tornier AEQUALIS FLEX REVIVE Shoulder System

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Image /page/6/Picture/0 description: The image shows the word "TORNIER" in a large, sans-serif font, colored in blue. To the right of the word is a logo consisting of a hexagon shape, also in blue. Inside the hexagon is a stylized letter "T", with a smaller hexagon shape inside the "T".

Distal Stem
Catalog #	Description	Diameter (mm)	Length (mm)
ARS741801	Distal Stem	Ø9	90
ARS741802	Distal Stem	Ø11	90
ARS741803	Distal Stem	Ø13	90
ARS741804	Distal Stem	Ø15	90
ARS741805	Distal Stem	Ø17	90
ARS741806	Distal Stem	Ø19	90
Assembly Screw
Catalog #	Description	Effective Length (mm)
ARS655101	Assembly Screw	0
ARS655102	Assembly Screw	20
ARS655103	Assembly Screw	30
ARS655104	Assembly Screw	40
ARS655105	Assembly Screw	50
ARS655118	Assembly Screw, Short	0
ARS655119	Assembly Screw, Short	20
Locking Cap
Catalog #	Description
ARS655200	Locking Cap

Intended Use

The AEQUALIS FLEX REVIVE Shoulder System is intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.

Indications for Use

IN ANATOMIC:

Rheumatoid arthritis with pain
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity

Tornier AEQUALIS FLEX REVIVE Shoulder System

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Image /page/7/Picture/0 description: The image shows the word "TORNIER" in a large, sans-serif font, colored in blue. To the right of the word is a logo consisting of a hexagon with a stylized letter "T" inside. The logo is also colored in blue and has a modern, geometric design.

Fractures of the humeral head
Traumatic arthritis
· Revision of other devices if sufficient bone stock remains

IN REVERSE:

The AEQUALIS FLEX REVIVE Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle 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 .
Massive and non repairable rotator cuff tear .
. Revision of the devices if sufficient bone stock remains

The reversed tray and polyethylene insert are indicated for use in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle.

Notes:

· All components are single use.
· The coated humeral stem is intended for cemented or cementless use.
· The all-poly glenoid components are intended for cemented use only
· The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium allovs are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

Comparison of Technological Characteristics with the Predicate Device

Table 5.2 compares the technological characteristics of the AFR shoulder System to the predicate. Aequalis Ascend Flex and the reference device. Aequalis Adiustable Reversed as applicable.

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		Table 5. 2 Comparison of Technological Characteristics
--	--	--------------------------------------------------------	--

	Aequalis Flex ReviveShoulder System (AFR)	Predicate Ascend Flex (K140082)Reference Device Adjustable Reversed(K141029)
Design Principal	Modular design to allow thesurgeon to select thecomponents to size the shouldersystem for the patient;convertible from anatomic toreversed without removing theimplant assembly	Ascend Flex – multiple sizes for surgeonselection; convertible from anatomic toreversed without removing the implantassembly.Adjustable Reverse - modular design toallow surgeon to select the componentsto size the shoulder system for thepatient.
Overall lengths	Adjustable total lengths from120mm to 180mm (10mmincrements)	Ascend Flex -66mm to 98mm (standard coated)88mm to 130mm (long coated)66mm to 94mm (standard non-coated)88mm to 125mm (long non-coated)Adjustable Reverse - adjustable length,using spacers, up to 210mm
Stem and SpacerDiameters(diaphysis)	9, 11, 13, 15, 17, 19 mm	Ascend Flex-Standard Stems: 9 – 20mmLong Stems: 9 – 20mmAdjustable Reverse - 9, 11, 13, 15, 17mm
Spacer length	20, 30 mm	Ascend Flex - N/AAdjustable Reversed - 15, 20, 25, 50, and100mm
Materials	Proximal body, spacers, distalstems: Titanium alloy(Ti6Al4V) and commerciallypure Ti (coating)Assembly Screw and LockingCap: CoCr	Titanium alloy (Ti6Al4V) andcommercially pure Ti (coating)
Sterility AssuranceLevel (SAL)	1x10-6	Identical
SterilizationMethod	Gamma	Identical

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Image /page/9/Picture/0 description: The image shows the word "TORNIER" in a large, sans-serif font, colored in blue. To the right of the word is a blue hexagon containing a stylized letter "T" inside. The letter "T" is also blue and has a unique design, with a smaller hexagon shape incorporated into its structure.

Non-clinical Performance Testing

Table 5.3 is a summary of the testing performed on the AEQUALIS FLEX REVIVE Shoulder System.

Table 5. 3 Summary of the Testing Performed on the AFR Shoulder System

Test Performed	Acceptance Criteria
Fatigue Testing	The humeral stems were tested to 10 million cycles (5 millionin each configuration) without failure, fracture, or dislocationwhen inspected after each tested configuration at amagnification of 50X.
Range of Motion	The Aequalis Flex Revive Shoulder System met the range ofmotion requirements in ASTM F1378-12.
Taper Tensile	Taper resultant force were not significantly lower than those ofthe Ascend Flex taper connections when analyzed with a 2-sample T-test.
Tensile Static Torque	The disassociation torque of the male taper from the femaletaper was not statistically lower than 1.72Nm, or two times theanticipated frictional torque between glenoid sphere and thereversed insert.
Press Fit Preparation	The AFR Shoulder System achieved a press-fit for the proximalbody and distal stem allowing the implant to attain properseating and acceptable fixation.
Cemented Preparation	The AFR Humeral Stem cement mantle thickness met orexceeded the Ascend Flex cement mantle thickness.
Biocompatibility	Biocompatibility requirements per ISO 10993-1 were met
Endotoxin	Endotoxin results per ST72 demonstrated <20EU/device
Packaging	Distribution testing met requirements per ASTM D4169-16

Conclusions

The AEQUALIS FLEX REVIVE Shoulder System has similar intended use and indications for use as the predicate, Ascend Flex Shoulder System (K140082). The reference device supports the use of the spacers to allow the surgeon to select the implant construct length for the patient. Testing demonstrated the AFR met the test requirements and compares favorably to the predicate. The AFR Shoulder System is substantially equivalent to the Ascend Flex Shoulder System.

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.”