Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)

K151500 · Custom Orthopaedic Solutions · KWS · Oct 5, 2015 · Orthopedic

Device Facts

• Record ID: K151500
• Device Name: Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)
• Applicant: Custom Orthopaedic Solutions
• Product Code: KWS · Orthopedic
• Decision Date: Oct 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2

Intended Use

The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers Apex, Keeled or Pegged Glenoid components as well as the Univers Revers Baseplate component. The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.

Device Story

Patient-specific manual instrument system; facilitates preoperative planning and intraoperative placement of central glenoid guide pin for total shoulder arthroplasty. Uses OrthoVis software to process patient imaging data for preoperative planning; enables surgeon to place Arthrex glenoid implants according to manufacturer labeling. System consists of reusable instruments; used in clinical settings by orthopedic surgeons. Output is a guide pin placement; assists in accurate glenoid preparation for implant reception. Benefits include improved surgical planning and precision in guide pin positioning.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including verification and validation of OrthoVis software modules and inter-/intra-user testing to confirm accurate placement of Arthrex implants per manufacturer labeling.

Technological Characteristics

Patient-specific manual instrument system. Includes OrthoVis software for preoperative planning. Connectivity: Standalone software module. Materials: Not specified. Principle: Mechanical guidance via patient-specific instruments for glenoid center pin placement.

Indications for Use

Indicated for patients undergoing total shoulder arthroplasty requiring glenoid component implantation using Arthrex Univers Apex, Keeled or Pegged Glenoid, or Univers Revers Baseplate components. Patient population matches the indications for the specific Arthrex shoulder systems used.

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

• Glenoid Intelligent Reusable Instrument System (Glenoid IRIS) (K142072)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of three human profiles facing to the right. The profiles are stacked on top of each other, with the first profile being the most prominent.

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

October 5, 2015

Custom Orthopaedic Solutions Mr. Keith Grafmeyer Product Engineer 10000 Cedar Avenue Cleveland, Ohio 44106

Re: K151500

Trade/Device Name: Arthrex Glenoid Intelligent Reusable Instrument System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: September 11, 2015 Received: September 11, 2015

Dear Mr. Grafmeyer:

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 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

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Page 2 - Mr. Keith Grafmeyer

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 [phone] or [phone] 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 [phone] or [phone] 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

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## Indications for Use

510(k) Number (if known) K151500

Device Name

Arthrex Glenoid Intelligent Reusable Instrument System

Indications for Use (Describe)

The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.

The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers Apex, Keeled or Pegged Glenoid components as well as the Univers Revers Baseplate component.

The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.

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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#### 510(k) Summary

| 510(k) SPONSOR / MANUFACTURER: | Custom Orthopaedic Solutions, Inc.<br>A subsidiary of Cleveland Clinic<br>10000 Cedar Avenue<br>Cleveland, Ohio 44106 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Keith Grafmeyer<br>Product Engineer<br>Custom Orthopaedic Solutions<br>10000 Cedar Avenue<br>Cleveland, OH 44106<br>Tel: [phone]<br>Email: [e-mail] |
| TRADE NAME: | Arthrex Glenoid Intelligent Reusable |

DATE PREPARED:

28-May-2015

#### COMMON NAMES:

Total shoulder replacement instruments

Instrument System (Arthrex Glenoid IRIS)

| Product | Product Code | Regulation and<br>Classification<br>Name | Device Class |
|----------------------------------------------------------------------------------------------|--------------|---------------------------------------------------------------------------------------------------|--------------|
| Arthrex Glenoid<br>Intelligent<br>Reusable<br>Instrument System<br>(Arthrex Glenoid<br>IRIS) | KWS, PHX | 21 CFR 888.3660<br>Shoulder Joint<br>Metal/Polymer,<br>Semi-Constrained<br>Cemented<br>Prosthesis | II |

#### PREDICATE DEVICES:

Glenoid Intelligent Reusable Instrument System (Glenoid IRIS) (K142072)

## DEVICE DESCRIPTION:

The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.

The Arthrex Glenoid Intelligent Reusable Instrument System described in this submission

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is identical to the Glenoid IRIS cleared in K142072, except for the following differences:

- The Glenoid IRIS for the K142072 clearance was indicated for use with the DePuy family of shoulder replacement systems. The subject device is indicated for use with the Arthrex family of glenoid components, which includes:
- o Univers™ II and Univers™ Apex Keeled Glenoid,
- O Univers™ II and Univers™ Apex Pegged Glenoid,
- o Univers Revers™ Baseplate.
- The DePuy implant models in the OrthoVis planning software have been replaced with Arthrex implant models.
- -The OrthoVis User's Manual and User Training Manual contain references to the implant company's instructions as to how their glenoid implants should be placed in patients. For this current submission, the User's Manual and User Training Manual have been changed to reflect the approved labeling for how Arthrex instructs these implants to be placed in patients.

All other elements of the K142072 clearance are identical to this submission.

#### INTENDED USE AND INDICATIONS:

The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.

The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers™ II or Arthrex Univers™ Apex, Keeled or Pegged Glenoid components as well as the Univers Revers™ Baseplate component.

The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.

#### BASIS OF SUBSTANTIAL EQUIVALENCE:

The "Arthrex Glenoid IRIS" is substantially equivalent to the Glenoid Intelligent Reusable Instrument System (Glenoid IRIS) described in K142072 because it is the same system with no modifications, other than the change from one shoulder implant system to another, similar shoulder implant system. Both the DePuy and Arthrex shoulder implant systems use a glenoid center pin to guide the subsequent preparation of the glenoid surface prior to implant placement.

## Non-Clinical Testing:

The following testing was performed to demonstrate substantial equivalency of the Arthrex Glenoid IRIS to the predicate device in K142072.

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- Verification and Validation of the OrthoVis software modules affected by . the change from DePuy to Arthrex implants, and confirmation that those changes had no other effects on any other parts of OrthoVis.
- OrthoVis inter- and intra-user testing, to confirm that OrthoVis users can . accurately place the Arthrex implants according to the Arthrex approved labeling for placement of their implants.

#### Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the modified Glenoid IRIS and the predicate Glenoid IRIS (K142072).