(90 days)
Not Found
No
The device description and intended use clearly describe a physical, non-electronic device (polyethylene plugs) used to restrict cement flow. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a cement restrictor used during surgery to control the flow of cement, not to treat or diagnose a disease.
No
The device, an intramedullary cement plug/restrictor, is used to control the flow of cement during surgery, not to diagnose a condition or disease.
No
The device description explicitly states the device is molded from polyethylene, indicating it is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Coonrad/Morrey Elbow Cement Restrictor is a physical device inserted into the body (intramedullary canal) during surgery. Its function is to physically impede the flow of cement, not to analyze biological specimens.
The provided information clearly describes a surgical implant used during a medical procedure, which falls under the category of a medical device, but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Intramedullary cement plugs are indicated for use in total joint arthroplasty to control, restrict or impede the flow of cement.
The larger intramedullary cement plugs are useful in revision surgery where a wide, smooth intramedullary canal must be plugged.
Product codes
JDC, JDB
Device Description
The Coonrad/Morrey Elbow Cement Restrictor is designed to impede the flow of bone cement distal to the prosthesis in the intramedullary canal during total elbow arthroplasty. The plugs are molded from polyethylene, and they are inserted into the intramedullary canal prior to the introduction of bone cement and insertion of the appropriate prosthesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intramedullary canal (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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing demonstrated that the Coonrad/Morrey Elbow Cement Restrictor meets performance requirements and is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized "Z" inside of it. To the right of the circle is the word "zimmer" in lowercase letters.
MAY 1 7 2004
Summary of Safety and Effectiveness
:
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Noah J. Bartsch, MS
Specialist, Regulatory Affairs
Telephone: (574) 371-8552
Fax: (574) 372-4605 |
| Date: | February 13, 2004 |
| Trade Name: | Coonrad/Morrey Elbow Cement Restrictor |
| Common Name: | Cement Obturator |
| Classification Name
and Reference: | Orthopaedic Surgical Mesh
21 CFR § 878.3300 |
| Predicate Devices: | Zimmer Allen Medullary Plugs, K001733, cleared
June 20, 2000.
Zimmer Poly-Plug™ Intramedullary System,
K950312, cleared May 17, 1995 |
| Device Description: | The Coonrad/Morrey Elbow Cement Restrictor is
designed to impede the flow of bone cement distal
to the prosthesis in the intramedullary canal during
total elbow arthroplasty. The plugs are molded
from polyethylene, and they are inserted into the
intramedullary canal prior to the introduction of
bone cement and insertion of the appropriate
prosthesis. |
| Intended Use: | Intramedullary cement plugs are indicated for use in
total joint arthroplasty to control, restrict or impede
the flow of cement.
The larger intramedullary cement plugs are useful
in revision surgery where a wide, smooth
intramedullary canal must be plugged. |
| Comparison to Predicate Device: | The Coonrad/Morrey Elbow Cement Restrictor is
equivalent to other commercially available
intramedullary cement plugs currently on the
market, by virtue of design and functionality. The
device has the same intended use as the predicate
devices, and has demonstrated the ability to
functionally perform the intended use. |
| Performance Data (Non-clinical): | Non-Clinical Performance and Conclusions: |
| | Non-clinical testing demonstrated that the
Coonrad/Morrey Elbow Cement Restrictor meets
performance requirements and is as safe and
effective as the predicate devices. |
1
Image /page/1/Picture/0 description: The image contains the word "zimmer" in a stylized font. To the left of the word is a circular logo with a bold letter "Z" inside. The letter "Z" is also stylized and fills most of the circle.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 2004
Noah J. Bartsch, MS Specialist, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Rc: K040389
Trade/Device Name: Coonrad/Morrey Elbow Cement Restrictor Regulation Number: 21 CFR 878.3150, 888.3160 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: JDC, JDB Dated: February 13, 2004 Received: February 17, 2004
Dear Mr. Bartsch:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your became 910(t) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regard want date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recalsmod in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, merciore, market the act include requirements for annual registration, listing of general controls provisions of the 120 labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see aborve) into Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional controllar Chile 21, Parts 800 to 898. In addition, FDA may be found in the Outs or enents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 177A s issuated of a backainments with other requirements of the Act
that FDA has made a determination that your device complies with other requirement that FDA has made a determination and Jointer Federal agencies. You must or any Federal statures and regulations damindiver, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as schoolenge CFR Part 807), fabening (21 CFRT at 001), good fif applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Noah J. Bartsch, MS
This letter will allow you to begin marketing your device as described in your Section 510(k) This icler with anow you to ogen maning of substantial equivalence of your device to a legally premailed notincation: The PDF intembly 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), please If you desire spoonly at (301) 594-4659. Also, please note the regulation entitled, Contact the Office of Compliance in (bet notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Millhussen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Coonrad/Morrey Elbow Cement Restrictor
Indications for Use:
Intramedullary cement plugs are indicated for use in total joint arthroplasty to control, restrict or impede the flow of cement.
The larger intramedullary cement plugs are useful in revision surgery where a wide, smooth intramedullary canal must be plugged.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Mark A. Milleson
Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K040384
0017