ZIMMER NEXEL TOTAL ELBOW

K123862 · Zimmer, Inc. · JDC · Mar 12, 2013 · Orthopedic

Device Facts

• Record ID: K123862
• Device Name: ZIMMER NEXEL TOTAL ELBOW
• Applicant: Zimmer, Inc.
• Product Code: JDC · Orthopedic
• Decision Date: Mar 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for: 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 is a constrained, cemented total elbow prosthesis designed to replace articulating surfaces and restore motion to the humeroulnar joint. Components include a humeral stem (with anterior flange and plasma spray for fixation), ulnar stem (with nitrogen-enriched, polished ulnar eye and plasma spray), Vitamin E highly cross-linked polyethylene bearings, cobalt-chromium-molybdenum screws, and an axle pin. Implanted by orthopedic surgeons in a clinical/surgical setting. The device functions as a mechanical replacement for the elbow joint; it does not involve software or algorithms. The design distributes joint reaction forces through the bearings. Benefits include restoration of motion and pain relief for patients with severe joint damage or instability.

Clinical Evidence

No clinical data provided. Substantial equivalence was demonstrated through non-clinical performance testing, including stem fatigue, wear, and durability testing.

Technological Characteristics

Constrained, cemented total elbow prosthesis. Materials: Titanium alloy (humeral/ulnar components), Vitamin E highly cross-linked polyethylene (bearings), cobalt-chromium-molybdenum alloy (screws/axle pin). Features: Plasma spray regions for bone cement fixation, nitrogen-enriched polished ulnar eye. No software, electronics, or connectivity.

Indications for Use

Indicated for patients with elbow joint destruction, post-traumatic lesions, bone loss, ankylosed joints, advanced rheumatoid/degenerative arthritis, joint instability, or acute comminuted articular fractures of the elbow joint surfaces requiring total elbow arthroplasty or revision. Contraindicated in cases of active sepsis.

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

• Coonrad/Morrey Total Elbow (K001989)
• Coonrad/Morrey Total Elbow (K053189)

Submission Summary (Full Text)

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K123862

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a

MAR 1 2 2013

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# 510(k) Summary of Safety and Effectiveness

| Sponsor: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joanna L. Surma<br>Associate Project Manager, Regulatory Affairs |
| Telephone: | [phone] |
| Fax: | [phone] |
| Date: | 13 December 2012 |
| Trade Name: | Zimmer Nexel Total Elbow |
| Common Name: | Total Elbow Prosthesis |
| Classification | 21 CFR § 888.3150<br>Elbow joint metal/polymer constrained cemented prosthesis |
| Product Code: | JDC – Prosthesis, Elbow, Constrained, Cemented |
| Predicate Device: | Coonrad/Morrey Total Elbow, manufactured by Zimmer,<br>K001989, cleared 25 July 2000 |
| | Coonrad/Morrey Total Elbow, manufactured by Zimmer,<br>K053189, cleared 9 December 2005 |
| Device Description: | The Zimmer Nexel total Elbow is a total elbow prosthesis<br>designed for use with bone cement. It is available in multiple<br>sizes and in right and left configurations. |
| | How the Device Functions: The Zimmer Nexel Total Elbow is<br>an implant designed to replace the articulating surfaces of and<br>restore motion to the humeroulnar (elbow) joint. The implant is a<br>constrained device assembly and consists of the following<br>components: humeral component, ulnar component, humeral<br>bearing-A, ulnar bearings-B, axle pin and humeral screws. |
| | The Following Scientific Concepts, Design Features and<br>Physical Properties form the Basis for the Zimmer Nexel<br>Total Elbow: The humeral component has a humeral stem<br>designed to be implanted with bone cement into the patient's<br>humeral medullary canal, an anterior flange designed to accept a |

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bone graft and limit torsional and posterior migration, a humeral yoke with rounded corners to avoid the creation of stress risers within the medial and lateral humeral supracondylar columns, and plasma spray region to enhance fixation to bone cement within the medullary canal, and to improve fatigue strength. The ulnar component has an ulnar stem designed to be implanted with bone cement into the patient's ulnar medullary canal, an ulnar eye that is both highly polished and nitrogen-enriched to limit wear of the apposing polymer bearings, and plasma spray region to enhance fixation to bone cement within the medullary canal. Bearings A and B are designed to broadly distribute joint reaction forces.

Materials Used: The humeral and ulnar components are made of a titanium alloy, the bearings A and B are made of Vitamin E highly cross-linked polyethylene, and the humeral screws and axle pin are made of a cobalt-chromium-molybdenum alloy.

Comparison to the Predicate: The proposed device (Zimmer Nexel Total Elbow) and the predicate device (Coonrad/Morrey Total Elbow) have the same intended use and similar indications for use. The proposed device humeral and ulnar components are very similar in terms of materials used and design/dimensions to the predicate device humeral and ulnar components. The primary differences between the proposed and predicate devices are that the proposed device bearing components are made of Vitamin E highly cross-linked polyethylene (the predicate device bearing components are made of ultra-high molecular-weight polyethylene), and the proposed device has bearings that articulate on both the outer and inner diameters of the ulnar eve (the predicate device has bearings that articulate on the inner diameter of the ulnar eye). Additionally, the proposed device uses screws and a 1-part axle pin to fix the bearings in place, while the predicate device uses a 2-part (snap-fit) axle pin.

## Intended Use:

Indications for use include:

- Elbow joint destruction which significantly compromises the activities of daily living ー
- 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.

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# 510(k) Summary of Safety and Effectiveness – Zimmer Nexel Total Elbow

The Zimmer Nexel Total Elbow is substantially equivalent to the Comparison to Predicate Device: predicate device in terms of form and function. The Zimmer Nexel Total Elbow and the predicate device share similar intended uses and indications for use. Non-Clinical Performance Testing Conducted: Performance Data: Stem Fatigue Testing --Wear Testing -Durability Testing Modular Connection Fatigue Testing -Non-Clinical Performance Testing Conclusions:

> Non-clinical testing demonstrated that the New Zimmer Total Elbow meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy.

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

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Letter dated: March 12, 2013

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

Zimmer, Incorporated % Ms. Joanna L. Surma Associate Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K123862

Trade/Device Name: Zimmer Nexel Total Elbow Regulation Number: 21 CFR 888.3150 Regulation Name: Elbow joint metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: JDC Dated: December 13, 2012 Received: December 14, 2012

Dear Ms. Surma:

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

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## Page 2 - Ms. Joanna L. Surma

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Mark N.INielkerson -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): ___ K123862

## Device Name:

Zimmer Nexel Total Elbow

## Indications for 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. { Hanley Ph: D Division of Orthopaedic Devices

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