(56 days)
Not Found
No
The summary describes a mechanical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a total elbow prosthesis, which is explicitly designed to treat and alleviate various medical conditions of the elbow joint, such as severe arthritis, instability, and destruction, thus fitting the definition of a therapeutic device.
No
This device is described as a "total elbow prosthesis and instrumentation" and an "accessory instrument" for joint replacement surgery. Its function is to divert excess bone cement during implantation, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it includes a cemented total elbow prosthesis and instrumentation, including a surgical technique modification and a physical cement diverter instrument. This indicates it is a hardware-based medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this is a total elbow prosthesis and associated instrumentation used for surgical implantation in the elbow joint.
- Intended Use: The intended uses all relate to treating conditions of the elbow joint through surgical intervention and implantation of a prosthetic device.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples or providing diagnostic information about a patient's health status. The device is a therapeutic implant and surgical tool.
Therefore, this device falls under the category of a surgical implant and related instruments, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JDC
Device Description
The Zimmer Nexel Total Elbow system includes a cemented total elbow prosthesis and instrumentation. No changes are being made to the implants, but two changes to the instrumentation are being proposed in this submission.
• The Zimmer Nexel Total Elbow surgical technique is being modified to include a back table utilization of the Ulnar Bearing Assembly Tool (UBAT).
• As a result of the surgical technique change, the subject Zimmer Nexel Total Elbow Ulnar Cement Diverter is being added as an accessory instrument to the existing Zimmer Nexel Total Elbow system. The proposed cement diverter is a sterile, single-use manual orthopedic instrument manufactured from Ultra High Molecular Weight Polyethylene in conformance with ASTM F648-14. The subject component diverts excess bone cement from the articular surfaces of the existing ulnar implant component during implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance and Conclusions:
The results of non-clinical testing demonstrate that the proposed surgical technique and cement diverter are safe and effective when utilized with the predicate, Nexel Total Elbow system, for their intended use. Testing/analysis performed included:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
(a)
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).(b)
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.”
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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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.
P.O. Box 708
Warsaw, IN 46581-0708 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Caroline Bloemker
Associate, Regulatory Affairs
Telephone: (574) 371-1980
Fax: (574) 372-4605 |
| Date: | February 24, 2015 |
| Trade Name: | Zimmer® Nexel® Total Elbow Ulnar Cement Diverter |
| Common Name: | Cement Diverter |
| Classification and
Product Code: | Class II Accessory
21 CFR § 888.3150 Elbow joint metal/polymer
constrained cemented prosthesis (JDC) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Zimmer® Nexel® Total Elbow, manufactured by Zimmer
Inc., K123862, cleared March 12, 2013. |
| Purpose and Device Description: | The Zimmer Nexel Total Elbow system includes a
cemented total elbow prosthesis and instrumentation. No
changes are being made to the implants, but two changes
to the instrumentation are being proposed in this
submission.
• The Zimmer Nexel Total Elbow surgical technique is
being modified to include a back table utilization of
the Ulnar Bearing Assembly Tool (UBAT).
• As a result of the surgical technique change, the
subject Zimmer Nexel Total Elbow Ulnar Cement
Diverter is being added as an accessory instrument to
the existing Zimmer Nexel Total Elbow system. The
proposed cement diverter is a sterile, single-use
manual orthopedic instrument manufactured from
Ultra High Molecular Weight Polyethylene in
conformance with ASTM F648-14. The subject
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
Nexel Total Elbow, it will assume the below Nexel Total
Elbow indications. |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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. |
| Comparison to Predicate Device: | The proposed surgical technique change does not have an
effect on the intended use or technological characteristics
of the predicate device.
The cement diverter is being introduced due to the change
in the surgical technique. Since the cement diverter is
unique to the Nexel Total Elbow system, it is being added
as a Class II accessory to the Nexel Total Elbow system
and assumes the same classification.
The proposed device is identical in intended use to the
predicate device. The materials, sterility, performance
characteristics, and technological characteristics are
comparable to the existing Nexel Total Elbow system and
do not introduce new questions of safety and
effectiveness. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
The results of non-clinical testing demonstrate that the
proposed surgical technique and cement diverter are safe
and effective when utilized with the predicate, Nexel Total
Elbow system, for their intended use. Testing/analysis
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.