(175 days)
No
The document describes a mechanical implant for elbow replacement and does not mention any AI or ML components or functionalities.
Yes
The device is an elbow implant used to treat conditions causing pain and loss of motion, which are therapeutic interventions.
No
The provided text describes a "Total Elbow" device, which is an implant used for joint replacement (arthroplasty). Its intended use is to treat existing conditions like post-traumatic lesions, ankylosed joints, or arthritis, rather than to identify or diagnose them.
No
The device description and intended use clearly describe a physical implant (Total Elbow) used in arthroplasty, not a software application. The performance studies also focus on mechanical properties of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for replacing the elbow joint due to various conditions like arthritis, trauma, and instability. This is a therapeutic device used in vivo (within the body).
- Device Description: The description refers to a "Total Elbow" and a "hinge pin assembly," which are components of a prosthetic joint.
- Anatomical Site: The anatomical site is the "Elbow," confirming it's a device for a specific body part.
- Performance Studies: The performance testing described relates to the mechanical properties of the device (force required to unlock the hinge pin assembly), not diagnostic performance.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device clearly does not fit that description.
N/A
Intended Use / Indications for Use
The Coonrad/Morrey Total Elbow is indicated for:
- Post-traumatic lesions or bone loss contributing to elbow instability .
- Ankylosed joints, especially in cases of bilateral ankylosis from causes other . than sepsis
- Advanced rheumatoid or degenerative arthritis with incapacitating pain .
- Instability or loss of motion when the degree of joint damage precludes less . radical procedures
The candidate for total elbow arthroplasty should exhibit joint destruction which significantly compromises the activities of daily living. Patients with single-joint involvement (generally those with traumatic or degenerative arthritis) or significant lower extremity disability which require walking aids are less amenable to treatment than patients with advanced and predominantly upper extremity involvement. If possible, elbow replacement should be done after hip or knee surgery to avoid excessive stress to the prosthesis required by crutch walking during total hip or knee rehabilitation.
Product codes
JDC
Device Description
The Coonrad/Morrey Total Elbow is closely based on the Coonrad III Total Elbow (K883665) cleared by FDA on February 3, 1989, with several exceptions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow
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
Performance testing was conducted to determine force required to unlock the hinge pin assembly. Results indicate the product is safe and effective.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font.
MAR - 2 1998
Summary of Safety and Effectiveness - Summary of Safety and Elbow, New Hinge Pin
-
Submitted by: .
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 -
Prepared by: .
Charlene Brumbaugh Specialist Global Regulatory Affairs Telephone: 219-372-4962 Telefax: 219-372-4605 -
Date: .
September 4, 1997 -
Trade Name: .
Coonrad/Morrey Total Elbow
Common Name: .
Elbow Prosthesis
Classification Name: .
constrained, Cemented Prosthesis, Elbow,
Predicate Devices: .
Coonrad III Total Elbow, marketed by Zimmer
Image /page/0/Picture/20 description: The image shows a geometric design. The design is composed of six triangles arranged around a central point. Each triangle is further divided into three smaller triangles, creating a star-like pattern within each larger triangle. The overall shape of the design is hexagonal.
1
Summary of Safety and Effectiveness Coonrad/Morrey Total Elbow, New Hinge Pin (Continued)
Device Description .
The Coonrad/Morrey Total Elbow is closely based on the Coonrad III Total Elbow (K883665) cleared by FDA on February 3, 1989, with several exceptions.
Intended Use .
The Coonrad/Morrey Total Elbow is indicated for:
- Post-traumatic lesions or bone loss contributing to elbow instability .
- Ankylosed joints, especially in cases of bilateral ankylosis from causes other . than sepsis
- Advanced rheumatoid or degenerative arthritis with incapacitating pain .
- Instability or loss of motion when the degree of joint damage precludes less . radical procedures
The candidate for total elbow arthroplasty should exhibit joint destruction which significantly compromises the activities of daily living. Patients with single-joint involvement (generally those with traumatic or degenerative arthritis) or significant lower extremity disability which require walking aids are less amenable to treatment than patients with advanced and predominantly upper extremity involvement. If possible, elbow replacement should be done after hip or knee surgery to avoid excessive stress to the prosthesis required by crutch walking during total hip or knee rehabilitation.
Performance Data .
Performance testing was conducted to determine force required to unlock the hinge pin assembly. Results indicate the product is safe and effective.
2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter, reading "DEPARTMENT OF HEALTH & HUM. SERVICES - USA". In the center is a stylized emblem consisting of three overlapping, curved shapes that resemble a caduceus without the snake. The emblem is rendered in black, contrasting with the white background of the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 1998
Ms. Charlene Brumbaugh ·Specialist Global Regulatory Affairs Zimmer P.O. Box 708 46581-0708 Warsaw, Indiana
Re: K973357 Coonrad/Morrey Total Elbow, New Hinge Pin Trade Name: Regulatory Class: III Product Code: JDC Dated: September 4, 1997 Received: "September 8, 1997
Dear Ms. Brumbaugh:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A-------substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
3
Page 2 - Ms. Charlene Brumbaugh
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colfa M. Witton, Ph.D., M
Witten, Ph.D., M.D. M. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K973357
Device Name: Coonrad/Morrey Total Elbow, New Hinge Pin
Indications For Use:
- Post-traumatic lesions or bone loss contributing to elbow instability ●
- Ankylosed joints, especially in cases of bilateral ankylosis from causes other than . sepsis
- Advanced rheumatoid or degenerative arthritis with incapacitating pain
- . Instability or loss of motion when the degree of joint damage precludes less radical procedures
The candidate for total elbow arthroplasty should exhibit joint destruction which significantly compromises the activities of daily living. Patients with single joint involvement (generally those with traumatic or degenerative arthritis) or significant lower extremity disability which require walking aids are less amenable to treatment than patients with advanced and predominantly upper extremity involvement. If possible, elbow replacement should be done after hip or knee surgery to avoid excessive stress to the prosthesis required by crutch walking during total hip or knee rehabilitation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K973357 |
| Prescription Use | X (Per 21 CFR 801.109) |
|---|---|
| ------------------ | ------------------------ |
OR
| Over-The-Counter Use | (Optional Format 1-2-96) |
|---|---|
| ---------------------- | -------------------------- |
RA08702K.510
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