Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay

K182039 · Arthrex, Inc. · PHX · Sep 28, 2018 · Orthopedic

Device Facts

Record IDK182039
Device NameArthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay
ApplicantArthrex, Inc.
Product CodePHX · Orthopedic
Decision DateSep 28, 2018
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3660
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System. The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE 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 Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is porous coated and is intended for cementless use with the addition of screws for fixation. The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated for use in anatomic joint replacement(s) when conditions including severe pain or significant disability resulting from degenerative, rheumatic disease, fracture or injury of the glenohumeral joint; non-union humeral head fractures of long duration; avascular necrosis of the humeral head; neoplastic diseases; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. For anatomic joint replacement, the Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated to be used with the humeral components of the Arthrex II Shoulder Prosthesis System for total shoulder arthroplasty. The UNIVERSAL GLENOID INLAY is intended for use with the UNIVERS REVERS POROUSE COATED BASEPLATE.

Device Story

Shoulder prosthesis system comprising porous-coated titanium glenoid baseplate and UHMWPE inlay bearing; used for total shoulder arthroplasty (anatomic or reverse). Baseplate features central barbed post and multi-directional screws for cementless fixation; inlay snaps into baseplate recesses to minimize rotation. Available in multiple sizes/thicknesses to accommodate anatomical variation. Used by orthopedic surgeons in clinical settings to replace damaged glenohumeral joints; relieves pain and restores function in patients with severe arthropathy or rotator cuff deficiency. Output is a mechanical joint replacement; clinical decision-making based on patient anatomy and pathology.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing: shear force, comparative testing, glenoid dynamic loosening, and locking mechanism disassembly. Coating compliance verified per FDA guidance for metallic plasma sprayed coatings. Pyrogen limit specifications met.

Technological Characteristics

Titanium porous-coated glenoid baseplate; UHMWPE inlay bearing. Cementless fixation via barbed post and screws. Modular design with multiple sizes and inlay thicknesses. Mechanical locking mechanism via snap-fit pegs. Class II device.

Indications for Use

Indicated for patients with grossly rotator cuff deficient glenohumeral joints, severe arthropathy, failed joint replacement, degenerative/rheumatic disease, fracture, injury, non-union humeral head fractures, avascular necrosis, or neoplastic/dysplastic diseases. Requires functional deltoid muscle and anatomically suited joint.

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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ September 28, 2018 Image /page/0/Picture/1 description: The image contains 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. Arthrex Inc. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples. Florida 34108-1945 #### Re: K182039 Trade/Device Name: Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, MBF Dated: July 26, 2018 Received: July 30, 2018 ### Dear Courtney Smith: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Daniel S. Ramsey -S 2018.09.28 10:01:59 -04'00' Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K182039 #### Device Name Arthrex UNIVERS REVERS POROUS COATED BASEPLATE and UNIVERSAL GLENOID INLAY #### Indications for Use (Describe) The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System. The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE 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 Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is porous coated and is intended for cementless use with the addition of screws for fixation. The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated for use in anatomic joint replacement(s) when conditions including severe pain or significant disability resulting from degenerative, rheumatic disease, fracture or injury of the glenohumeral joint; non-union humeral head fractures of long duration; avascular necrosis of the humeral head; neoplastic diseases; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. For anatomic joint replacement, the Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated to be used with the humeral components of the Arthrex II Shoulder Prosthesis System for total shoulder arthroplasty. The UNIVERSAL GLENOID INLAY is intended for use with the UNIVERS REVERS POROUS COATED BASEPLATE. Type of Use (*Select one or both, as applicable*) | <span style="font-size: 10px;"> <input checked="true" type="checkbox"/> Destination Host (21 CFR 301 Subpart B) </span> | <span style="font-size: 10px;"> <input type="checkbox"/> Own-Firm Consignment (21 CFR 301 Subpart C) </span> | |----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| |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](mailto: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." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the Arthrex logo. The logo is blue and features the word "Arthrex" in a stylized font. To the right of the word is an image of a surgical tool. The logo is simple and professional. ## 510(k) Summary or 510(k) Statement | Date Prepared | September 27, 2018 | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 | | Contact Person | Courtney Smith Manager, Regulatory Affairs 1-239-643-5553, ext. 71720 Courtney.smith@arthrex.com | | Name of Device | Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY | | Common Name | Shoulder Prosthesis | | Product Code | PHX, MBF | | Classification Name | Prosthesis, Shoulder, semi-constrained metal/polymer, cemented, CFR 888.3660 Prosthesis, Shoulder, semi-constrained metal/polymer, uncemented, CFR 888.3670 | | Regulatory Class | II | | Predicate Device | Primary – K172371: Arthrex Univers Revers Coated Baseplate Reference – K161120: Lima SMR TT Metal Back Glenoid K162068: Arrow Anatomical Porous Glenoid | | Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for the Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY. | | Device Description | The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY consists of a porous coated titanium glenoid baseplate and a UHMWPE inlay bearing. The baseplate is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System. The baseplate is centrally anchored by a barbed post with superior and inferior multi-directional screws to ensure optimal fixation. The baseplate and inlay bearing come in three sizes to match anatomical size variations. | | | For a reversed shoulder application, the baseplate can be paired with the Univers Revers glenosphere. | | | For an anatomic shoulder application, the baseplate should be paired with the inlay bearing. The inlay bearing is available in two thicknesses (standards and +2mm) and in sizes corresponding to the glenoid baseplate. Pegs on the underside of the inlay bearing snap into corresponding recesses in the baseplate, ensuring a secure attachment to the bearing inlay, while at the same time minimizing angular rotation. | | Indications for Use | The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System. | | | The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the Arthrex logo in blue. The logo consists of the word "Arthrex" in a bold, sans-serif font, followed by the registered trademark symbol. To the right of the word is an image of a surgical tool, possibly a type of clamp or forceps, also in blue. | | device. | |------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is indicated for<br>primary, fracture, or revision total shoulder replacement for the relief of pain<br>and significant disability due to gross rotator cuff deficiency. | | | The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is porous coated and<br>is intended for cementless use with the addition of screws for fixation. | | | The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL<br>GLENOID INLAY are indicated for use in anatomic joint replacement(s) when<br>conditions including severe pain or significant disability resulting from<br>degenerative, rheumatoid, traumatic disease, fracture or injury of the<br>glenohumeral joint; non-union humeral head fractures of long duration;<br>avascular necrosis of the humeral head; neoplastic or dysplastic diseases; or<br>other difficult clinical management problems where arthrodesis or resectional<br>arthroplasty is not acceptable. | | | For anatomic joint replacement, the Arthrex UNIVERS REVERS POROUS COATED<br>BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated to be used with the<br>humeral components of the Arthrex Univers II Shoulder Prosthesis System for<br>total shoulder arthroplasty. The UNIVERSAL GLENOID INLAY is intended for use<br>with the UNIVERS REVERS POROUS COATED BASEPLATE. | | Performance Data | Performance testing (shear force, comparative, glenoid dynamic loosening<br>testing and locking mechanism disassembly testing) demonstrated that the<br>Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID<br>INLAY performs equivalently to the predicate device. | | | Non-clinical testing demonstrates that the baseplate coating is in compliance<br>with the FDA Guidance for Industry on Testing of Metallic Plasma Sprayed<br>Coatings on Orthopedic Implants to Support Reconsideration of Postmarket<br>Surveillance Requirements. | | | The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL<br>GLENOID INLAY meets pyrogen limit specifications. | | Conclusion | The proposed device is substantially equivalent to the predicate devices in which<br>the basic design features and intended uses are the same. Any differences<br>between the proposed device and the predicate device are considered minor and<br>do not raise questions concerning safety or effectiveness. | | | Based on the indications for use, technological characteristics, and the summary<br>of data submitted, Arthrex Inc. has determined that the proposed device is<br>substantially equivalent to the currently marketed predicate device. |
Innolitics
510(k) Summary
Decision Summary
Classification Order
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