IN ANATOMIC:
The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral head may be used by themselves, as a hemiarthroplasty. if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Aequalis Fx2 is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Aequalis Fx2 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 proximal humerus
Traumatic arthritis
Revision of other devices if sufficient bone stock remains

IN REVERSE:
The Aequalis Fx2 is indicated for use as a replacement of shoulder joints with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

Rheumatoid arthritis
Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
Correction of functional deformity
Fractures of the proximal humerus
Traumatic arthritis
Revision of the devices if sufficient bone stock remains.

The reversed insert is permitted to be used in the transformation to reverse Aequalis Fx2 without the removal of the humeral stem, and if it is well fixed, during a revision surgery, for patient with a functional deltoid muscle.

Device Description

The Aequalis Fx2 is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.

The Aequalis Fx2 consists of:
in an anatomic configuration, a humeral stem compatible with Flex Shoulder System humeral heads ; Or

in a reversed configuration, a humeral stem and a reversed insert, compatible with Aequalis Reversed/Aequalis Reversed II glenoid implants.
The Aequalis Fx2 is intended for use as:
traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures,
in case of bone defect in the proximal part of the humerus,
a replacement of shoulder joints in primary anatomic or in primary reverse,
a replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. -

The Aequalis Fx2 also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called Aequalis Fx2, a shoulder prosthesis. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo acceptance criteria and proving performance through a clinical study with a test set, ground truth, and expert evaluation as would be common for AI/ML-based devices.

Therefore, the specific information requested in the prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not applicable to this type of regulatory submission for a traditional medical device (implant) like the Aequalis Fx2.

Instead, the document details physical and mechanical testing and a comparison of materials, design, and intended use to existing, cleared devices.

Here's a breakdown of what is provided, and why the requested information isn't present:

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

Not Applicable in the traditional sense. For this device, "acceptance criteria" are related to mechanical and material properties meeting established standards and demonstrating equivalence to predicate devices, not diagnostic performance metrics (like sensitivity, specificity, accuracy).
What is provided: Table 1 on page 6 compares "Main features or system characteristics" of the Aequalis Fx2 to several predicate devices, including materials, standards, stem fixation, stem length, and diameter of reversed insert. This comparison aims to show technological equivalence.
Device Performance: The document states:
- "The results of these tests [pull out, torque, and fatigue testing] demonstrate the equivalence between the Aequalis Fx2 and the predicate devices." (Page 7)
- This implies that the Aequalis Fx2 performed comparably to the predicate devices in these mechanical tests, thus meeting the "acceptance criteria" for demonstrating substantial equivalence on a technical level. Specific numerical performance values are not provided as they would be for a software device.

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

Not Applicable. This device is a physical implant, not an AI/ML diagnostic or therapeutic device that would use a test set of data (e.g., images, patient records). The testing described (pull-out, torque, fatigue) are physical tests on the device itself.
What is provided: The document mentions "pull out, torque testing, and fatigue testing were performed." (Page 7). The sample size for these engineering tests is not specified in this summary.

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

Not Applicable. Ground truth, in the context of diagnostic AI/ML, refers to a definitive correct answer established by experts or other definitive means. This concept does not apply to the mechanical testing of a physical implant.

4. Adjudication method for the test set:

Not Applicable. As no test set of data is used in the AI/ML sense, there is no need for an adjudication method.

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. MRMC studies are used to evaluate the impact of a diagnostic tool (often AI) on human performance (e.g., radiologists reading images). This device is a surgical implant and does not involve human readers interpreting data.

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

Not Applicable. This device is solely a physical implant. There is no algorithm to evaluate in a standalone manner.

7. The type of ground truth used:

Not Applicable. As explained in point 3, the concept of "ground truth" for diagnostic evaluation is not relevant here. The "truth" for this device lies in its physical properties and mechanical performance meeting established engineering standards and showing equivalence to legally marketed devices.

8. The sample size for the training set:

Not Applicable. This device does not involve machine learning; therefore, there is no "training set."

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

Not Applicable. As there is no training set for machine learning, this question is not relevant.

In summary: The provided document is a 510(k) submission for a non-AI medical device (a shoulder prosthesis). It demonstrates "substantial equivalence" to predicate devices through comparisons of design, materials, and mechanical testing results (pull-out, torque, and fatigue). The requested information primarily pertains to the evaluation of AI/ML-based diagnostic devices and is therefore not found within this type of regulatory submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of three human profiles facing to the right.

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

November 18, 2014

TORNIER S.A.S. Maud Andriollo Regulatory Affairs Specialist 161 rue Lavoisier 38330 Montbonnot Saint Martin FRANCE

Re: K141345

Trade/Device Name: Aequalis Fx2 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: October 28, 2014 Received: October 30, 2014

Dear Maud Andriollo:

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

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Page 2 – Maud Andriollo

(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 (OS) 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/Resourcesfor You/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/ResourcesforYou/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K141345

Device Name Aequalis Fx2

Indications for Use (Describe)

IN ANATOMIC:

The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral head may be used by themselves, as a hemiarthroplasty. if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Aequalis Fx2 is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Aequalis Fx2 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 proximal humerus
Traumatic arthritis
Revision of other devices if sufficient bone stock remains

IN REVERSE:

The Aequalis Fx2 is indicated for use as a replacement of shoulder joints with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

Rheumatoid arthritis
Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
Correction of functional deformity
Fractures of the proximal humerus
Traumatic arthritis
Revision of the devices if sufficient bone stock remains.

Notes:

all components are single use.
the humeral stem is for cemented use only.
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.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the word "TORNIER" in large, bold, blue font. Below that, in a smaller, bold, blue font, are the words "Implants Chirurgicaux". The words are stacked on top of each other and centered.

510 (k) Summary of Safety and Effectiveness information Traditional 510(k) Premarket – Aequalis Fx2

Date: November, 14th 2014

1) Device name
Trade name:	Aequalis Fx2
Common name:	Shoulder Prosthesis
Classification name:

· Shoulder joint metal/polymer semi-constrained cemented prosthesis are class II devices under 21 CFR 888.3660 (product code KWS) and are classified by the Orthopedic Devices Panel
· Shoulder joint metal/polymer semi-constrained cemented prosthesis are class II devices under 21 CFR 888.3660 (product code PHX)
Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis are class II devices under . CFR 888.3690 (product code HSD) and are classified by the Orthopedic Devices Panel

2) Submitter :

TORNIER SAS 161 rue Lavoisier 38330 Montbonnot Saint Martin- France Registration Number: 3000931034

3) Company contact :

Tornier Mrs Maud Andriollo Regulatory Affairs Specialist 161 rue Lavoisier 38334 Montbonnot Tel: 00 33 4 76 61 35 00 Fax: 00 33 4 76 61 35 59 e-mail:maud.andriollo@tornier.com

4) Classification

Device class:	Class II
Classification panel:	Orthopedic
Product code:	KWS, PHX, HSD

5) Equivalent / Predicate device : Aequalis Ascend Flex Shoulder System, TORNIER SAS, K122698

Image /page/3/Picture/14 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is formed by geometric shapes, creating a modern and abstract design. The hexagon and the 'T' are both in a light blue or lavender color, contrasting with the white background. The logo appears clean and simple, suitable for a tech company or a brand with a focus on innovation.

TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A

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Image /page/4/Picture/0 description: The image contains the name "TORNIER" in large, bold, blue font. Below that, in a smaller, bold, blue font, is the phrase "Implants Chirurgicaux". The text appears to be a logo or brand name for a company that produces surgical implants.

Aequalis Shoulder Fracture System, TORNIER SAS, K060209, K131231 Aequalis Reversed Fracture Shoulder Prosthesis, TORNIER SAS, K082120, K131231 Comprehensive Reverse Shoulder System, BIOMET, K113069

6) Device description :

The Aequalis Fx2 is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.

The Aequalis Fx2 consists of:

in an anatomic configuration, a humeral stem compatible with Flex Shoulder System humeral heads ; । Or

in a reversed configuration, a humeral stem and a reversed insert, compatible with Aequalis । Reversed/Aequalis Reversed II glenoid implants.
The Aequalis Fx2 is intended for use as:
। traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures,
in case of bone defect in the proximal part of the humerus, ।
a replacement of shoulder joints in primary anatomic or in primary reverse, ।
a replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. -

The Aequalis Fx2 also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

7) Materials :

The humeral stem is manufactured from titanium alloy (Ti6Al4V) in accordance with ISO 5832-3 and coated with hydroxylapatite (HAP) in accordance with ASTM standard F-1185 or ISO 13779-2.

The reversed insert is manufactured from UHMWPE according to ISO standard 5834-2 and titanium alloy (Ti6Al4V) in accordance with ISO 5832-3.

8) Indications :

IN ANATOMIC:

The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The Aequalis Fx2 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 Fx2 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 proximal humerus ।
-Traumatic arthritis
Revision of other devices if sufficient bone stock remains. -

Image /page/4/Picture/26 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is constructed from geometric shapes, giving it a modern and abstract appearance. The color of the logo is a light shade of blue or lavender, providing a soft and clean aesthetic. The hexagon shape provides a clear border for the logo.

TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A

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Image /page/5/Picture/0 description: The image shows the logo for Tornier Implants Chirurgicaux. The word "TORNIER" is in large, bold, blue font on the top line. The words "Implants Chirurgicaux" are in a smaller, bold, blue font on the second line.

IN REVERSE:

The Aequalis Fx2 is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

Rheumatoid arthritis ।
Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) ।
। Correction of functional deformity
Fractures of the proximal humerus -
-Traumatic arthritis
Revision of the devices if sufficient bone stock remains. ।

The reversed insert is permitted to be used in the transformation from anatomic to reverse Aequalis Fx2 without the removal of the humeral stem, and if it is well fixed, during a revision surgery, for patient with a functional deltoid muscle.

Notes:

all components are single use. ।
the humeral stem is for cemented use only. -
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.
the humeral head diameters 37 and 39mm must be utilized only with the stem with a small metaphysis. -The humeral head must cover completely the stem metaphysis.

Image /page/5/Picture/16 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is constructed from geometric shapes, giving it a modern and abstract appearance. The hexagon and the 'T' are both colored in a light blue or lavender hue. The logo is simple and clean, suggesting a focus on design and possibly technology or innovation.

TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A

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Image /page/6/Picture/0 description: The image displays the word "TORNIER" in large, bold, blue font. Below this, the words "Implants Chirurgicaux" are written in a smaller, blue font. The text appears to be a logo or heading, possibly for a medical or surgical company specializing in implants.

9) Summary of technological characteristics

Table 1: Main features comparison

Main features orsystem characteristics		Aequalis Fx2	Aequalis Ascend FlexShoulder System	Aequalis ShoulderFracture System	Aequalis ReversedFracture ShoulderProsthesis	Comprehensive ReverseShoulder System
Material	Stem	Titanium + HAP	Titanium + Ti PlasmaSpray	Titanium + HAP	Titanium + HAP	Titanium + Ti PorousPlasma spray
	ReversedInsert	UHMWPE + Titanium	UHMWPE + Titanium	NA	UHMWPE	Titanium + UHMWPE
Standard	Stem	ASTM F136 / ISO 5832-3	ASTM F136 / ISO 5832-3	ASTM F136 / ISO 5832-3	ASTM F136 / ISO 5832-3	unknown
	Coating	ASTM F1185	ASTM F1580	ASTM F1185	ASTM F1185	ASTM F1580
	ReversedInsert	ISO 5834-2 + ISO 5832-3	ISO 5834-2 + ISO 5832-3	NA	ISO 5834-2	unknown
Stem fixation		Cemented on distal partUncemented on proximalpart	Cemented or uncemented	Cemented on distal partUncemented on proximalpart	Cemented use	Cemented or uncemented
Stem length		90; 130; 170; 210 mm	66; 70; 74; 78; 82; 86; 88;90; 93; 94; 98; 104; 109;115; 120; 125 mm	130; 170; 180; 210 mm	130; 170; 180; 210 mm	55; 83; 122; 194 mm
Diameter of reversedinsert		36mm, 42mmThickness 6; 9; 12 mm	36mm, 42mmThickness 6; 9 mm	NA	36mm, 42mmThickness 6; 9; 12mm	31mm, 36mm, 41mm
Terminal sterilization		Yes	Yes	Yes	Yes	Yes
Manufacturer		Tornier	Tornier	Tornier	Tornier	Biomet
K-number		Pending	K122698	K060209, K131231	K082120, K131231	K113069

Image /page/6/Picture/4 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is rendered in a light purple or lavender color and appears to be constructed from geometric shapes, giving it a modern and somewhat abstract look. The hexagon provides a clean, geometric border around the 'T', further emphasizing the logo's contemporary design. The background is plain white, which makes the logo stand out.

TORNIER S.A.S. Tél. : 33 (0)4 76 61 35 00 161, rue Lavoisier Fax : 33 (0)4 76 61 35 33 38334 MONTBONNOT CEDEX FRANCE

S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A

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Image /page/7/Picture/0 description: The image shows the words "TORNIER Implants Chirurgicaux" in a dark blue font. The word "TORNIER" is in a larger font than the words "Implants Chirurgicaux". The words are stacked on top of each other, with "TORNIER" on top and "Implants Chirurgicaux" on the bottom. The background is white.

The design, the indication for use, the manufacturing principle, the method of fixation of the stem, the packaging and the sterilization process of the Aequalis Fx2 are identical or equivalent to the predicate devices.

10) Non-clinical testing

Pull out, torque testing, and fatigue testing were performed.

The aim of pull out and torque testing is to validate the locking mechanism between a metal part simulating an Aequalis Fx2 humeral stem and an UHMWPE simulating reversed insert.
-The aim of fatigue testing in anatomic configuration is to evaluate the fatigue strength of the Aequalis Fx2 implant in an anatomic configuration.
-The aim of fatigue testing in reversed configuration is to evaluate the fatigue strength of the Aequalis Fx2 implant in a reversed configuration after anatomic configuration.

The results of these tests demonstrate the equivalence between the Aequalis Fx2 and the predicate devices.

11) Substantial equivalence conclusion

Based upon this comparative study, substantial equivalence of the Aequalis Fx2 to the predicates can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision Making Process:

-The Aequalis Fx2 is compared to the predicate devices.
The Aequalis Fx2 has the same intended use as the cleared predicates. -
-Major technological characteristics are equivalent between the Aequalis Fx2 and the predicate devices:
- Equivalence of general features -
- -Equivalent means of fixation
- -Equivalent material
- -Equivalent prosthetic dimensions

Therefore, in the light of the above information, the Aequalis Fx2 is found to be equivalent to the predicate devices.

Image /page/7/Picture/18 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is rendered in a light blue or lavender color and appears to be constructed from geometric shapes, giving it a modern and somewhat abstract look. The hexagon provides a clear, defined border for the logo, making it stand out.

TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A

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.”