Who is the manufacturer of Anatomical Shoulder System?

Zimmer GmbH filed the 510(k) submission for Anatomical Shoulder System (K193099).

What is the FDA product code for Anatomical Shoulder System?

PHX. It is classified under 21 CFR 888.3660 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Anatomical Shoulder System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Anatomical Shoulder System?

ASHCOM™ Shoulder System (K170711); Anatomical Shoulder™ System (K170711); Anatomical Shoulder™ Combined System (K170711).

Who can help prepare an FDA 510(k) submission like Anatomical Shoulder System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Anatomical Shoulder System

K193099 · Zimmer GmbH · PHX · Jan 29, 2020 · Orthopedic

Device Facts

Record ID	K193099
Device Name	Anatomical Shoulder System
Applicant	Zimmer GmbH
Product Code	PHX · Orthopedic
Decision Date	Jan 29, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3660
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision (Reverse Shoulder Arthroplasty), 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.

Device Story

The Anatomical Shoulder System is a modular shoulder prosthesis for total, hemi-, or reverse arthroplasty. It replaces the proximal humerus and/or glenoid articular surface to relieve pain and restore function. Components include humeral stems (cemented/uncemented), glenoids (pegged, keeled, hybrid, Trabecular Metal), glenospheres, and adapters. Used by orthopedic surgeons in clinical settings. The device is implanted surgically; it provides mechanical joint stability and articulation. Benefits include pain relief and improved mobility for patients with degenerative joint disease, fractures, or rotator cuff deficiency. The system is designed for long-term implantation.

Clinical Evidence

No clinical data was required or provided for this submission. Substantial equivalence is supported by non-clinical performance testing, including mechanical integrity/resistance testing for instruments and packaging validation per ISO 11607-1:2006 and ISO 11607-2:2006.

Technological Characteristics

Modular shoulder prosthesis system comprising metallic humeral stems, metal/polymer glenoid components, and associated hardware. Materials include titanium (porous peg) and polyethylene. Designed for cemented or cementless fixation. Packaging validated per ISO 11607-1/2. No software or electronic components.

Indications for Use

Indicated for patients with advanced shoulder joint wear/tear (degenerative, posttraumatic, rheumatoid arthritis), avascular necrosis, conditions from prior operations, or complex 3/4-part proximal humerus fractures. Reverse configuration indicated for pain/disability due to gross rotator cuff deficiency with functional deltoid muscle. Requires adequate bone stock.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

ASHCOM™ Shoulder System (K170711)
Anatomical Shoulder™ System (K170711)
Anatomical Shoulder™ Combined System (K170711)

Related Devices

K213856 — Identity Shoulder System · Zimmer, Inc. · Sep 15, 2022
K231657 — AGILON® XO Shoulder Replacement System · Implantcast GmbH · Feb 16, 2024
K060988 — TOTAL AND HEMI SHOULDER SYSTEM · Dvo Extremity Solutions, LLC · Dec 6, 2006
K980244 — AEQUALIS SHOULDER PROSTHESIS · Tornier · Aug 23, 1999
K081620 — MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM · DePuy Orthopaedics, Inc. · Jun 30, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 29, 2020 Zimmer GmbH Dawn Balazs-Metz Regulatory Affairs Senior Specialist Sulzerallee 8 WINTERTHUR 8404 CH Re: K193099 Trade/Device Name: Anatomical Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, HSD, KWS, KWT, PAO Dated: November 4, 2019 Received: November 7, 2019 Dear Dawn Balazs-Metz: 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 {1}------------------------------------------------ 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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality 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) K193099 Device Name Anatomical 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 if bone stock is adequate. • Avascular necrosis. · Conditions consequent to earlier operations. · Optional use in revision: in some medical conditions (e.g. early revision when adequate bone stock exits), the surgeon may opt to use primary implants in a revision procedure). 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 Anaverse Anatomical Shoulder Pegged Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended 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 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 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 4-part 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 use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented are intended for cemented use only. Anatomical Shoulder Combined System FORM FDA 3881 (7/17) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. Advanced destruction of the shoulder joint resulting from: • Omarthrosis • Rheumatoid arthritis {3}------------------------------------------------ - · 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 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 Long 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) ### 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/3 description: The image contains the Zimmer Biomet logo. The logo consists of a blue circle with a stylized "Z" inside, followed by the words "ZIMMER BIOMET" in a sans-serif font. The color of the text is a light blue, matching the color of the "Z" symbol. # 510(k) Summary | Sponsor: | Zimmer GmbH Sulzerallee 8, P.O. Box 8404 Winterthur, Switzerland | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Dawn Balazs-Metz Senior Specialist, Regulatory Affairs Telephone: +41 58 854 81 37 Fax: +41 52 244 86 58 | | Date: | November 04, 2019 | | Trade Name: | Anatomical Shoulder™ System | | Classification Product Code : | PHX - Shoulder Prosthesis, Reverse Configuration HSD - Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWT - Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented PAO - Prosthesis, Shoulder, Semi-constrained, Metal/Polymer + Additive, Cemented | | Device Classification Name: | Shoulder Prosthesis | | Regulation Number / Description: | 21 CFR § 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis 21 CFR § 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis 21 CFR § 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis | | Predicate Device: | ASHCOM™ Shoulder System, Anatomical Shoulder™ System, and Anatomical Shoulder™ Combined System, manufactured by Zimmer GmbH, K170711, cleared June 1, 2017. | | Device Description: | Anatomical Shoulder™ System | | | The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision (Reverse Shoulder Arthroplasty), 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 proposed Anatomical Shoulder System is comprised of the following families of products: | {5}------------------------------------------------ Image /page/5/Picture/3 description: The image shows the Zimmer Biomet logo. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a gray, sans-serif font. The logo is simple and modern, and the colors are clean and professional. | | Anatomical Shoulder Humeral Stems (Cemented, Uncemented) | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Anatomical Shoulder Reverse System (Cups, PE-inlays, Glenoid Fixation, Screws, Glenospheres) | | | Anatomical Shoulder Fracture System (Stems, Heads) | | | Anatomical Shoulder Combined system (Bigliani / Flatow® Adaptors) | | | Anaverse™ Anatomical Shoulder Pegged Glenoid | | | Anatomical Shoulder Domelock® System (Heads, Dome Centric, T- Domes) | | | Anatomical Shoulder ASHCOM® Shoulder System (ASHCOM Shoulder AC-Connector) | | Indications for use: | 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 if bone stock is adequate. | | | • Avascular necrosis. | | | • Conditions consequent to earlier operations. | | | • Optional use in revision: in some medical conditions (e.g. early revision when adequate bone stock exits), the surgeon may opt to use primary implants in a revision procedure). | | | 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 Anaverse Anatomical Shoulder Pegged 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 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 | {6}------------------------------------------------ Image /page/6/Picture/2 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a dark gray color. 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 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 Anaverse Anatomical Shoulder Pegged 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 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 Long 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 Anatomical Shoulder System is being merged. Through merging of the IFU redundant indications have been removed and three {7}------------------------------------------------ Image /page/7/Picture/2 description: The image contains the logo of Zimmer Biomet, a medical device company. The logo consists of a stylized letter 'Z' enclosed in a circle, followed by the company name 'ZIMMER BIOMET' in capital letters. The 'Z' and the circle are in blue, while the company name is in gray. | existing indications have been reworded for more clarity surrounding revision cases. The removal and clarification of the indications for the subject device limits the use of the devices within the currently cleared indications. A clarification to the previously cleared MR verbiage for the proposed device harmonizes the information provided to the user across the Zimmer Biomet shoulder portfolio. The clarification to the MR verbiage does not change compatibility/ final scanning recommendations provided to the user. | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Modification of the packaging configuration for the subject implant devices is proposed. The proposed changes do not alter the fundamental scientific technology shared by both the subject devices and predicate devices. | | | | Zimmer GmbH is furthermore seeking clearance for certain system-specific Class II instruments - these instruments that have previously considered Class I exempt and correction of classification to Class II is proposed within present submission. | | | | Performance Data (Nonclinical and/or Clinical): | | Non-Clinical Performance and Conclusions: | | | | Results of non-clinical performance testing and analyses demonstrate that the Anatomical Shoulder System is safe and effective and substantially equivalent to the predicate devices. Performance analyses included: | | | | MR compatibility evaluation on the Anatomical Shoulder™ System. | | | | No new MRI performance testing or simulations were completed for the Anatomical Shoulder™ System implant devices. The reports were only reviewed with the aim ensure that appropriate labelling of the Zimmer Shoulder implant systems be implemented upon harmonization of the MR verbiage across the Zimmer Biomet portfolio. | | | | Correction of instrument classification from Class I to Class II: | | | | Mechanical integrity and resistance testing was performed for instrument groups of mechanically loaded devices. | | | | Packaging configuration change: | | | | Packaging performance testing was performed to verify that packaging configuration maintains integrity of the sterile barrier system up to the point of use and provides adequate protection to the product through the hazards of sterilization, handling, distribution and storage according to ISO 11607-1:2006 and ISO 11607-2:2006. Packaging Configuration testing was conducted by representative worst-case products. | | | | Clinical Performance and Conclusions: | | | | Clinical data and conclusions were not needed for this device. | | Conclusion: | | The subject devices have the same intended use and similar indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design and labeling and are manufactured and sterilized using the same materials and processes as the predicate devices. | {8}------------------------------------------------ Image /page/8/Picture/2 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside it, followed by the text "ZIMMER BIOMET" in a simple, sans-serif font. The text is in a neutral gray color, providing a contrast to the blue logo. devices are identical to the predicate devices, and the performance data and analyses demonstrate that: - . any differences do not raise new questions of safety and effectiveness as established with performance testing; and - . the subject devices are at least as safe and effective as the legally marketed predicate devices.