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 intented 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 intented 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
· The Anatomical Shoulder Inverse/Reverse System is 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.

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 glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasts 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.

Device Description

The Anatomical Shoulder System is a modular shoulder prosthesis designed to be used in primary or revision, total or hemi shoulder arthroplasty.

Anatomical Shoulder Humeral Stems are available as either cemented or uncemented designs. Cemented stems are available in longer designs to support revision cases. The Anatomical Shoulder Fracture Stem is available as a slim and standard version, with longer stems available for revision surgery. They may be used with or without bone cement where appropriate fixation using cement or via a press-fit is achieved using the correct choice of rasp size. All Humeral Stems possess a female oval taper geometry, which is the basis for all modularity with compatible mating components. The stems can be combined with the Anatomical Shoulder Domelock Head or the Anatomical Shoulder Ball-taper Humeral Head. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component of the Anatomical Shoulder System for total arthroplasty. Alternatively, the Legacy Biomet Bio-Modular Keeled all-polyethylene Glenoid or Modular Hybrid Glenoids are proposed as compatible glenoid components.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification from Zimmer GmbH to the FDA for the Anatomical Shoulder™ System, Anatomical Shoulder Domelock® System, and Anatomical Shoulder™ Fracture System.

It describes the device and its intended use, but it does NOT describe an AI/ML-based medical device performance study, nor does it contain information about acceptance criteria or performance against such criteria for an AI/ML device.

The document states:
"The devices are not modified as compared to their predicates. Instead, the compatibility of the Anatomical Shoulder Humeral Heads is extended to allow articulation against the legally marketed Bio-Modular Keeled all-polyethylene Glenoid and the Modular Hybrid Glenoid. The indications for use/intended use are unchanged. The articulating materials remain the same with the new compatibility and therefore the fundamental technology is unchanged."

And for Performance Data:
"The results of non-clinical performance testing and analyses demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance analyses included:

Range of Motion Analysis (ASTM F1378-12)
Radial Mismatch Analysis
Clinical Performance and Conclusions: Clinical data and conclusions were not needed to demonstrate substantial equivalence."

Therefore, I cannot answer your specific questions regarding acceptance criteria for an AI/ML device and its study, as the provided text pertains to a traditional orthopedic implant (shoulder prosthesis) and not an AI/ML-based medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, representing the human element of the department's work.

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

March 8, 2016

Zimmer Gmbh Ms. Annemie Rehor Kausch Senior Specialist Regulatory Affairs Sulzerallee 8 8404 Winterthur Switzerland

Re: K160085

Trade/Device Name: Anatomical Shoulder™ System, Anatomical Shoulder Domelock® System, Anatomical Shoulder™ Fracture System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT, HSD, PHX Dated: January 8, 2016 Received: January 15, 2016

Dear Ms. Rehor 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

{1}------------------------------------------------

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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,

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K160085

Device Name

Anatomical Shoulder™ System Anatomical Shoulder™ Domelock® Anatomical Shoulder™ Fracture System

Indications for Use (Describe)

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.

Reverse Application of the Anatomical Shoulder System

· The Anatomical Shoulder Inverse/Reverse System is 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 arthroplasts 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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

{3}------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a stylized blue letter "Z" inside of a blue circle. Below the circle is the word "zimmer" in a lowercase, sans-serif font, also in blue.

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:	March, 1st 2016
Trade Name:	Anatomical Shoulder™ SystemAnatomical Shoulder ™ Domelock®Anatomical Shoulder ™ Fracture System
Classification Product Code /	HSD - Prosthesis, Shoulder, Hemi-, Humeral,Metallic UncementedKWS - Prosthesis, Shoulder, Semi-Constrained,Metal/Polymer CementedKWT - Prosthesis, Shoulder, Non-Constrained,Metal/Polymer CementedPHX - Shoulder Prosthesis, Reverse Configuration
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:	Anatomical Shoulder System / Anatomical ShoulderDomelock / Anatomical Shoulder Fracture System,manufactured by Zimmer GmbH, K142403, clearedNovember 24, 2014

{5}------------------------------------------------

Anatomical Shoulder with Removable Head, manufactured by Zimmer GmbH, K030259, cleared April 24, 2003

Anatomical Shoulder Fracture Stem, K062029, cleared July 17, 2006.

The Anatomical Shoulder System is a modular shoulder prosthesis designed to be used in primary or revision, total or hemi 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

Intended Use:

Indications for Use:

Device Description:

{6}------------------------------------------------

· 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

· 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.

Fracture Application of the Anatomical Shoulder Fracture System

{7}------------------------------------------------

	The Anatomical Shoulder Fracture System is intendedfor use in prosthetic replacement of the proximalhumerus and the glenoid articular surface of thescapula during total-, hemi and fracture shoulderarthroplasty in treatment of the following:• Complex 3- and 4-part fractures of the proximalhumerus with subluxation of the head fragment• Complex 3- and 4-part fractures of the proximalhumerus with loosening of the spongiosa in the headfragment• Complex 3- and 4-part fractures of the proximalhumerus with additional cross split of the headfragment• Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus• Posttraumatic necrosis of the humeral head• Posttraumatic arthrosis after humeral head fractureThe Humeral Fracture Stems are intended for eithercemented or uncemented use. When used in a totalshoulder application, the Anatomical ShoulderPegged and Keeled Glenoids Cemented are intendedfor cemented use only.
Comparison to Predicate Device:	The devices are not modified as compared to theirpredicates. Instead, the compatibility of theAnatomical Shoulder Humeral Heads is extended toallow articulation against the legally marketed Bio-Modular Keeled all-polyethylene Glenoid and theModular Hybrid Glenoid. The indications foruse/intended use are unchanged. The articulatingmaterials remain the same with the new compatibilityand therefore the fundamental technology isunchanged.
Performance Data (Nonclinicaland/or Clinical):	The results of non-clinical performance testing andanalyses demonstrate that the devices are safe andeffective and substantially equivalent to the predicatedevices. Performance analyses included:1. Range of Motion Analysis (ASTM F1378-12)2. Radial Mismatch Analysis
	Clinical Performance and Conclusions: Clinical dataand conclusions were not needed to demonstratesubstantial 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.”