The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.

The ASHCOM Shoulder System is intended for reverse shoulder arthroplasty.

Hemi or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System
The Anatomical Shoulder Humeral Stems and Domelock System are indicated for
• Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
• Avascular necrosis.
• Conditions consequent to earlier operations.
• Omarthrosis.
• Rheumatoid arthritis.
• Revision of shoulder prosthesis.

The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended for cemented use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

Reverse Application of the Anatomical Shoulder System and ASHCOM Shoulder System
• The Anatomical Shoulder Inverse/Reverse System and the ASHCOM Shoulder System are indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
• The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.

Fracture Application of the Anatomical Shoulder Fracture System
The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasty in treatment of the following:
• Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment
• Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment
• Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment
• Fracture instability after osteosynthesis of 3- and 4part fracture fragments of the proximal humerus
• Posttraumatic necrosis of the humeral head
• Posttraumatic arthrosis after humeral head fracture

The Humeral Fracture Stems are intended for either cemented or uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only.

Anatomical Shoulder Combined System
Advanced destruction of the shoulder joint resulting from:
• Omarthrosis.
• Rheumatoid arthritis
• Post-traumatic arthritis
• Avascular necrosis of the humeral head
• Cuff-tear arthropathy (Bigliani/Flatow Heads with heights of 27mm or greater)
• Conditions following earlier operations (including revision shoulder arthroplasty).

The Anatomical Shoulder Combined System is intended for cemented or cementless use.

When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented use:
• Anatomical Shoulder Standard Cemented Humeral Stem.
• Anatomical Shoulder Revision Stem.

When used with the following humeral stem the Anatomical Shoulder Combined System is intended for cementless use:
• Anatomical Shoulder Standard Uncemented Stem.

When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented or cementless use:
• Anatomical Shoulder Fracture Stem.
• Anatomical Shoulder Fracture Long Stem.

When used with the following glenoids the Anatomical Shoulder Combined System is intended for cemented use:
• Bigliani/Flatow Glenoid (pegged and keeled).
• Trabecular Metal™ Glenoid.

Device Description

The ASHCOM Shoulder AC-Connector is a double tapered Adaptor that allows the combination of the Anatomical Shoulder Humeral Stems with the Comprehensive Trays. The male oval cone taper of the ASHCOM Shoulder AC-Connector is compatible with the cemented, uncemented and fracture humeral stems of the Anatomical Shoulder System. The female round taper is compatible with the Comprehensive Reverse Trays. In combination with compatible Zimmer Biomet reverse glenoid the implant is intended for a reverse application. The existing Anatomical Shoulder System, for which MR conditional labeling is proposed, is a modular shoulder prosthesis designed to be used in primary or revision, total or hemi shoulder arthroplasty. The existing Anatomical Shoulder Combined System, for which MR conditional labeling is proposed, allows the combination of a Bigliani/Flatow® Head with any Anatomical Shoulder Humeral Stem.

AI/ML Overview

The provided text does not contain detailed acceptance criteria for a medical device or a comprehensive study demonstrating that the device meets these criteria. The document is primarily a 510(k) premarket notification for shoulder prosthetic systems (ASHCOM™ Shoulder System, Anatomical Shoulder™ System, Anatomical Shoulder™ Combined System), aiming to establish substantial equivalence to previously cleared predicate devices.

Instead, the document focuses on:

Indications for Use: What conditions the devices are intended to treat.
Device Description: The components and general design of the prosthetic systems.
Comparison to Predicate Device: How the new devices are similar to existing, legally marketed devices.
Performance Data (Nonclinical): A list of non-clinical tests performed to support safety and effectiveness, particularly for the ASHCOM Shoulder System and the MRI compatibility of the Anatomical Shoulder systems.

Here's an analysis based on the information provided, highlighting what's present and what's explicitly absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with specific quantitative targets and corresponding device performance data to demonstrate compliance.

Instead, it lists the types of non-clinical tests performed to show safety and equivalence:

Test Type	Reported Purpose/Outcome
Finite Element Stress analysis	Performed under worst-case conditions; aimed to demonstrate safety and effectiveness, and substantial equivalence.
Cyclic fatigue testing	Performed under worst-case conditions; aimed to demonstrate safety and effectiveness, and substantial equivalence.
Accelerated Corrosion Fatigue Testing	Performed; aimed to demonstrate safety and effectiveness, and substantial equivalence.
Static taper connection testing per ASTM F2009	Performed; aimed to demonstrate safety and effectiveness, and substantial equivalence.
MRI compatibility evaluation	Evaluated per "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" Guidance (August 2014) to support "MR Conditional" labeling for the Anatomical Shoulder and Anatomical Shoulder Combined Systems.

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

For the non-clinical tests listed, the document does not specify sample sizes (e.g., number of prostheses tested) or data provenance (e.g., country of origin, retrospective/prospective). These details would typically be found within the full test reports, which are not included in this summary.

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

This section is not applicable as the document describes non-clinical performance testing of physical devices (implants), not a study involving evaluation by medical experts to establish ground truth for a diagnostic or AI-driven system.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3.

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

This section is not applicable. The device is an orthopedic implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study involving human readers and AI assistance was conducted or mentioned.

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

This section is not applicable. The device is an orthopedic implant and does not involve an algorithm.

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

For the non-clinical performance tests, "ground truth" would not be established by expert consensus, pathology, or outcomes data in the traditional sense. Instead, the "ground truth" or reference state is defined by engineering specifications, material properties, and regulatory standards (e.g., ASTM F2009 for taper connection testing). The tests aim to demonstrate that the physical properties and performance of the device meet these predefined engineering and safety criteria.

8. The sample size for the training set

This section is not applicable. The device is an orthopedic implant, and there is no mention of an algorithm or AI model that would require a training set.

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

This section is not applicable for the same reasons as point 8.

Summary of what the document does indicate regarding device performance and acceptance:

The submission relies on non-clinical performance testing and analysis to demonstrate the safety and effectiveness of the ASHCOM Shoulder System and the existing Anatomical Shoulder systems (for MRI compatibility labeling) and establish their substantial equivalence to predicate devices. The listed tests (FEA, cyclic fatigue, corrosion fatigue, static taper connection) are standard for orthopedic implants to assess mechanical integrity, durability, and material performance. For MRI compatibility, the evaluation followed FDA guidance, suggesting a series of tests to confirm the "MR Conditional" status.

The statement "Results of non-clinical performance testing and analyses demonstrate that the ASHCOM Shoulder System is safe and effective and substantially equivalent to the predicate devices" serves as the overall conclusion regarding acceptance based on the conducted studies, without detailing the specific quantitative acceptance criteria or results in this summary. The FDA's clearance (K170711) indicates that they found the provided non-clinical data sufficient to establish substantial equivalence.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

June 1, 2017

Zimmer Gmbh Dr. Annemie Rehor Kausch Senior Specialist Regulatory Affairs Sulzerallee 8. P.O. Box 8404 Winterthur. Switzerland

Re: K170711

Trade/Device Name: ASHCOM™ Shoulder System, Anatomical Shoulder™ System And Anatomical Shoulder™ Combined System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, HSD, KWS, KWS, KWT, PAO Dated: March 7, 2017 Received: March 8, 2017

Dear Dr. Kausch:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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" (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.

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.

Mark N. Melkerson -S

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) K170711

Device Name

ASHCOM™ Shoulder System Anatomical Shoulder™ System Anatomical Shoulder™ Combined System

Indications for Use (Describe) Anatomical Shoulder System and ASHCOM Shoulder System

Hemi or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System The Anatomical Shoulder Humeral Stems and Domelock System are indicated for

· Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or theumatoid arthritis.
· Avascular necrosis.
· Conditions consequent to earlier operations.
· Omarthrosis.
· Rheumatoid arthritis.
· Revision of shoulder prosthesis.

Reverse Application of the Anatomical Shoulder System and ASHCOM Shoulder System

· The Anatomical Shoulder Inverse/Reverse System and ASHCOM Shoulder System are indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. • The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

Fracture Application of the Anatomical Shoulder Fracture System

The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasty in treatment of the following:

· Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment
· Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment
· Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment
Fracture instability after osteosynthesis of 3- and 4-part fragments of the proximal humerus
· Posttraumatic necrosis of the humeral head
· Posttraumatic arthrosis after humeral head fracture

The Humeral Fracture Stems are intended for either cemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Anatomical Shoulder Combined System

· Omarthrosis.

Advanced destruction of the shoulder joint resulting from:

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• Rheumatoid arthritis

Post-traumatic arthritis
· Avascular necrosis of the humeral head
· Cuff-tear arthropathy (Bigliani/Flatow Heads with heights of 27mm or greater)

· Conditions following earlier operations (including revision shoulder arthroplasty).

The Anatomical Shoulder Combined System is intended for cemented or cementless use.

When used with the following humeral stems the Anatomical System is intended for cemented use:

· Anatomical Shoulder Standard Cemented Humeral Stem.
· Anatomical Shoulder Revision Stem.

When used with the following humeral stem the Anatomical System is intended for cementless use: · Anatomical Shoulder Standard Uncemented Stem.

When used with the following humeral stems the Anatomical System is intended for cemented or cementless use:

· Anatomical Shoulder Fracture Stem.
· Anatomical Shoulder Fracture Long Stem.

When used with the following glenoids the Anatomical System is intended for cemented use:

· Bigliani/Flatow Glenoid (pegged and keeled).
• Trabecular Metal™ Glenoid.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/1 description: The image contains the logo for Zimmer Biomet. The logo features a blue circle with a stylized "Z" inside it. Below the circle, the word "zimmer" is written in lowercase, using the same blue color as the circle and "Z".

Zimmer GmbH Sulzerallee 8
8404 Winterthur Switzerland

510(k) Summary

Sponsor:	Zimmer GmbHSulzerallee 8, P.O. Box8404 Winterthur, Switzerland
Contact Person:	Annemie Rehor KauschSenior Specialist, Regulatory AffairsTelephone: +41 58 854 82 61Fax: + 41 52 244 86 58
Date:	May, 09, 2017
Trade Name:	ASHCOM TM Shoulder SystemAnatomical Shoulder TM SystemAnatomical Shoulder TM Combined System
Classification Product Code /	PHX – Shoulder Prosthesis, Reverse ConfigurationHSD - Prosthesis, Shoulder, Hemi-, Humeral,Metallic UncementedKWS - Prosthesis, Shoulder, Semi-Constrained,Metal/Polymer CementedKWT - Prosthesis, Shoulder, Non-Constrained,Metal/Polymer CementedPAO - Prosthesis, Shoulder, Semi-constrained,Metal/Polymer + Additive, Cemented
Device Classification Name:	Shoulder Prosthesis
Regulation Number / Description:	21 CFR § 888.3690 – Shoulder joint humeral(hemishoulder) metallic uncemented prosthesis21 CFR § 888.3660 – Shoulder joint metal/polymersemi-constrained cemented prosthesis21 CFR § 888.3650 – Shoulder joint metal/polymernon-constrained cemented prosthesis
Predicate Device:	The following devices serve as predicate for theASHCOM Shoulder System:

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Anatomical Shoulder System manufactured by Zimmer GmbH, K142403, cleared November 24, 2014 Comprehensive Reverse Shoulder, manufactured by Biomet Inc. K080642, cleared September 7, 2008, K113069, cleared January 11, 2012 and K113121, cleared December 16, 2011. The following predicate devices are labelled "MR conditional": Anatomical Shoulder System, manufactured by Zimmer GmbH, K990136, cleared March, 01, 1999; K030259, cleared April, 24, 2003; K051623, cleared July, 19, 2005, K053274, January, 25, 2006; K052906, cleared December, 19, 2005; K062029, cleared October, 31, 2006; K142403 cleared November 24, 2014, K160085, cleared March, 8, 2016 and K161620, cleared November, 1, 2016. Anatomical Shoulder Combined System, manufactured by Zimmer GmbH, K103404, cleared May, 15th, 2011. The ASHCOM Shoulder AC-Connector is a double tapered Adaptor that allows the combination of the Anatomical Shoulder Humeral Stems with the Comprehensive Trays. The male oval cone taper of the ASHCOM Shoulder AC-Connector is compatible with the cemented, uncemented and fracture humeral stems of the Anatomical Shoulder System. The female round taper is compatible with the Comprehensive Reverse Trays. In combination with compatible Zimmer Biomet reverse glenoid the implant is intended for a reverse application. The existing Anatomical Shoulder System, for which MR conditional labeling is proposed, is a modular shoulder prosthesis designed to be used in primary or revision, total or hemi shoulder arthroplasty. The existing Anatomical Shoulder Combined System, for which MR conditional labeling is proposed, allows the combination of a Bigliani/Flatow® Head with any Anatomical Shoulder Humeral Stem.

Device Description:

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Intended Use:	The Anatomical Shoulder System is intended forlong-term implantation into the human shoulder jointin primary or revision, total or hemi shoulderarthroplasty. The system is intended to relieve painand restore function in patients with adequate bonestock to support the prosthesis.
	The ASHCOM Shoulder System is intended forreverse shoulder arthroplasty.
Indications for Use:	Hemi or Total Arthroplasty Application of theAnatomical Shoulder Humeral Stems and DomelockSystemThe Anatomical Shoulder Humeral Stems andDomelock System are indicated for• Advanced wear and tear of the shoulder jointresulting from degenerative, posttraumatic orrheumatoid arthritis.• Avascular necrosis.• Conditions consequent to earlier operations.• Omarthrosis.• Rheumatoid arthritis.• Revision of shoulder prosthesis.
	The Humeral Stems Cemented are intended forcemented use and the Humeral Stems Uncementedare intended for uncemented use. When used in a totalshoulder application, the Anatomical ShoulderPegged and Keeled Glenoids Cemented and theBiomet all-polyethylene Keeled Glenoid are intendedfor cemented use only. The Biomet Modular HybridGlenoid is intended to be implanted with bonecement. The optional porous titanium peg may beinserted without bone cement. The optionalpolyethylene peg should be inserted with bonecement.
	Reverse Application of the Anatomical ShoulderSystem and ASHCOM Shoulder System
	• The Anatomical Shoulder Inverse/Reverse Systemand the ASHCOM Shoulder System are indicated forprimary, fracture or revision total shoulderreplacement for the relief of pain and significant

disability due to gross rotator cuff deficiency. • The patient's joint must be anatomically and structurally suited to receive the selected implants and

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a functional deltoid muscle is necessary to use the device.

Fracture Application of the Anatomical Shoulder Fracture System

The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasty in treatment of the following: · Complex 3- and 4-part fractures of the proximal

humerus with subluxation of the head fragment · Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment

· Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment

· Fracture instability after osteosynthesis of 3- and 4part fracture fragments of the proximal humerus

Posttraumatic necrosis of the humeral head
· Posttraumatic arthrosis after humeral head fracture

Anatomical Shoulder Combined System Advanced destruction of the shoulder joint resulting from:

Omarthrosis.
Rheumatoid arthritis
Post-traumatic arthritis
Avascular necrosis of the humeral head

• Cuff-tear arthropathy (Bigliani/Flatow Heads with heights of 27mm or greater)

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· Conditions following earlier operations (including revision shoulder arthroplasty).

The Anatomical Shoulder Combined System is intended for cemented or cementless use.

When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented use:

· Anatomical Shoulder Standard Cemented Humeral Stem.

· Anatomical Shoulder Revision Stem.

When used with the following humeral stem the Anatomical Shoulder Combined System is intended for cementless use:

· Anatomical Shoulder Standard Uncemented Stem.

When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented or cementless use:

· Anatomical Shoulder Fracture Stem.
· Anatomical Shoulder Fracture Long Stem.

When used with the following glenoids the Anatomical Shoulder Combined System is intended for cemented use:

· Bigliani/Flatow Glenoid (pegged and keeled).
· Trabecular Metal™ Glenoid.

Comparison to Predicate Device:

The ASHCOM AC-Connector allows the combination of the Anatomical Shoulder Humeral Stems with the Comprehensive Reverse Trays. The indications are shared with the reverse application of the Anatomical Shoulder predicate device. The ASHCOM AC-Connector utilizes the same material as the Anatomical Shoulder Humeral Stem and the same manufacturing process, and has similar technical features as the Anatomical Shoulder predicate device.

This submission further covers a labeling modification to the existing Anatomical Shoulder and Anatomical Shoulder Combined System. The labeling modification consists of the addition of Magnetic Resonance Imaging (MRI) compatibility information to the Package Insert, and application of the "MR

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Conditional" symbol on the package label. No other changes are proposed.

Performance Data (Nonclinical and/or Clinical):

Results of non-clinical performance testing and analyses demonstrate that the ASHCOM Shoulder System is safe and effective and substantially equivalent to the predicate devices. Performance analyses included:

Finite Element Stress analysis and cyclic fatigue testing under worst case conditions 2. Accelerated Corrosion Fatigue Testing 3. Static taper connection testing according ASTM F2009

The components of the ASHCOM Shoulder System, the Anatomical Shoulder System and the Anatomical Shoulder Combined System and have been evaluated for compatibility in the MRI environment, per Guidance for Industry and FDA Staff, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", August 2014. Based upon the results, the subject shoulder implants are recommended to bear the "MR Conditional" labeling and include MR compatibility safety information within the package insert.

Clinical Performance and Conclusions: Clinical data and conclusions were not needed to demonstrate substantial equivalence.

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.”