Zimmer Nexel Total Elbow Ulnar Cement Diverter

K150501 · Zimmer, Inc. · JDC · Apr 23, 2015 · Orthopedic

Device Facts

• Record ID: K150501
• Device Name: Zimmer Nexel Total Elbow Ulnar Cement Diverter
• Applicant: Zimmer, Inc.
• Product Code: JDC · Orthopedic
• Decision Date: Apr 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3150
• Device Class: Class 2

Intended Use

Indications for use include: - Elbow joint destruction which significantly compromises the activities of daily living - Post-traumatic lesions or bone loss contributing to elbow instability - Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis - Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain - Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis - Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus - Revision arthroplasty Caution: This device is intended for cemented use only.

Device Story

Zimmer Nexel Total Elbow Ulnar Cement Diverter is a sterile, single-use manual orthopedic instrument; used during total elbow arthroplasty. Device functions by diverting excess bone cement from articular surfaces of ulnar implant component during implantation. Used in clinical/OR settings by orthopedic surgeons. Output is physical diversion of cement; assists surgeon in achieving proper implant seating and preventing cement-related complications. Benefits patient by ensuring secure, clean fixation of prosthetic components.

Clinical Evidence

No clinical data. Evidence provided via non-clinical performance testing: cadaveric evaluation confirmed safety/effectiveness of design and surgical technique; functional relationship analysis confirmed fit and compatibility with existing ulnar components.

Technological Characteristics

Manual orthopedic instrument; material: Ultra High Molecular Weight Polyethylene (UHMWPE) per ASTM F648-14; sterile, single-use; designed for use with Zimmer Nexel Total Elbow system.

Indications for Use

Indicated for patients with elbow joint destruction, post-traumatic lesions/bone loss, ankylosed joints, advanced arthritis (rheumatoid, post-traumatic, degenerative), joint instability, or acute comminuted articular fractures requiring revision arthroplasty or total elbow replacement.

Regulatory Classification

Identification

An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device 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,” (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,” (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,” (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 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Zimmer® Nexel® Total Elbow (K123862)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with three human profiles incorporated into its design.

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

April 23, 2015

Zimmer. Incorporated Ms. Caroline Bloemker Regulatory Affairs Associate P.O. Box 708 Warsaw, Indiana 46580

Re: K150501

Trade/Device Name: Zimmer® Nexel® Total Elbow Ulnar Cement Diverter Regulation Number: 21 CFR 888.3150 Regulation Name: Elbow joint metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: JDC Dated: February 24, 2015 Received: February 26, 2015

Dear Ms. Caroline Bloemker:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Ms. Caroline Bloemker

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Lori A. Wiggins -S

for

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) K150501

Device Name

Zimmer® Nexel® Total Elbow Ulnar Cement Diverter

Indications for Use (Describe)

Indications for use include:

- Elbow joint destruction which significantly compromises the activities of daily living
- Post-traumatic lesions or bone loss contributing to elbow instability
- Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis
- Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain
- Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis

- Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus

- Revision arthroplasty

CAUTION: This device is intended for cemented use only.

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

> 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."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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

Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized letter "Z" inside it. Below the circle, the word "zimmer" is written in lowercase, blue letters. The font used for the word "zimmer" is a sans-serif typeface.

## 510(k) Summary

| Sponsor: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Caroline Bloemker<br>Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | February 24, 2015 |
| Trade Name: | Zimmer® Nexel® Total Elbow Ulnar Cement Diverter |
| Common Name: | Cement Diverter |
| Classification and<br>Product Code: | Class II Accessory<br>21 CFR § 888.3150 Elbow joint metal/polymer<br>constrained cemented prosthesis (JDC) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Zimmer® Nexel® Total Elbow, manufactured by Zimmer<br>Inc., K123862, cleared March 12, 2013. |
| Purpose and Device Description: | The Zimmer Nexel Total Elbow system includes a<br>cemented total elbow prosthesis and instrumentation. No<br>changes are being made to the implants, but two changes<br>to the instrumentation are being proposed in this<br>submission.<br><br>• The Zimmer Nexel Total Elbow surgical technique is<br>being modified to include a back table utilization of<br>the Ulnar Bearing Assembly Tool (UBAT).<br><br>• As a result of the surgical technique change, the<br>subject Zimmer Nexel Total Elbow Ulnar Cement<br>Diverter is being added as an accessory instrument to<br>the existing Zimmer Nexel Total Elbow system. The<br>proposed cement diverter is a sterile, single-use<br>manual orthopedic instrument manufactured from<br>Ultra High Molecular Weight Polyethylene in<br>conformance with ASTM F648-14. The subject<br>component diverts excess bone cement from the |

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

articular surfaces of the existing ulnar implant component during implantation.

| Intended Use: | Since the subject component is a Class II accessory to the<br>Nexel Total Elbow, it will assume the below Nexel Total<br>Elbow indications. |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for use include:<br>- Elbow joint destruction which significantly<br>compromises the activities of daily living<br>- Post-traumatic lesions or bone loss contributing to<br>elbow instability<br>- Ankylosed joints, especially in cases of bilateral<br>ankylosis from causes other than active sepsis<br>- Advanced rheumatoid, post-traumatic, or degenerative<br>arthritis with incapacitating pain<br>- Instability or loss of motion when the degree of joint<br>or soft tissue damage precludes reliable osteosynthesis<br>- Acute comminuted articular fracture of the elbow joint<br>surfaces that precludes less radical procedures,<br>including 13-C3 fractures of the distal humerus<br>- Revision arthroplasty<br>Caution: This device is intended for cemented use only. |
| Comparison to Predicate Device: | The proposed surgical technique change does not have an<br>effect on the intended use or technological characteristics<br>of the predicate device.<br>The cement diverter is being introduced due to the change<br>in the surgical technique. Since the cement diverter is<br>unique to the Nexel Total Elbow system, it is being added<br>as a Class II accessory to the Nexel Total Elbow system<br>and assumes the same classification.<br>The proposed device is identical in intended use to the<br>predicate device. The materials, sterility, performance<br>characteristics, and technological characteristics are<br>comparable to the existing Nexel Total Elbow system and<br>do not introduce new questions of safety and<br>effectiveness. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>The results of non-clinical testing demonstrate that the<br>proposed surgical technique and cement diverter are safe<br>and effective when utilized with the predicate, Nexel Total<br>Elbow system, for their intended use. Testing/analysis<br>performed included: |

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

- -Cadaveric Evaluation confirmed the safety and effectiveness of the final cement diverter design and surgical technique update when used with the Nexel Total Elbow ulnar component.
- Functional Relationship Analysis (FRA) confirmed compatibility requirements to ensure the cement diverter fits appropriately to all existing Nexel Total Elbow ulnar components.

Clinical Performance and Conclusions:

In this case, clinical data and conclusions were not needed to demonstrate substantial equivalence.

Substantial Equivalence Zimmer considers the proposed cement diverter to be a Conclusions unique instrument to the Nexel Total Elbow system; therefore, it will assume the intended use of the predicate device. It does not introduce new materials, biocompatibility concerns, indications or risks, and therefore Zimmer considers the new surgical technique and cement diverter substantially equivalent to the predicate submission.