(89 days)
Not Found
No
The summary describes a purely mechanical device (titanium frame) with no mention of software, algorithms, or data processing, which are typically associated with AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
Explanation: The device is designed to restrict cement flow during surgery to facilitate cement pressurization, not to treat a disease or condition. Its function is purely mechanical and procedural.
No
Explanation: The device, a cement restrictor, is designed to occlude the medullary canal and prevent cement flow during surgery. Its function is interventional and supportive during a surgical procedure, not to diagnose a condition or provide diagnostic information.
No
The device description explicitly states the device is a physical object made of titanium with a specific shape and features, indicating it is a hardware device.
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 Function: The Theken Large Cement Restrictor is a physical device designed to be implanted into the medullary canal during surgery. Its function is to physically block and contain cement, not to analyze biological samples.
- Intended Use: The intended use clearly describes a surgical procedure (total hip arthroplasty) and a mechanical function (occluding the medullary canal and preventing cement flow).
Therefore, the Theken Large Cement Restrictor falls under the category of a surgical implant or accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Theken Large Cement Restrictor is designed to occlude the medullary canal before the introduction of acrylic cement during surgeries such as total hip arthroplasty, as well as prevent cement from flowing down the diaphysis thereby facilitating cement pressurization. The Theken Large Cement Restrictor is NOT intended for any spinal indications.
Product codes
JDK
Device Description
The Theken Large Cement Restrictor is titanium, hollow, rectangular frame with The Thelions and radii on all sides and toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Medullary canal (specifically for total hip arthroplasty), diaphysis. Spinal indications are explicitly excluded.
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: Static evaluation was performed and the strength of the device was characterized.
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
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
510(k) Summary
012462
OCT 2 9 2001
Theken Large Cement Restrictor
510 (k) Summary
- Theken Surgical Company: 1100 Nola Ave. Barberton, OH 44203
Theken Large Cement Restrictor Trade Name:
Classification: JDK 21CFR878.3300. Surgical Mesh. Class II.
Description:
The Theken Large Cement Restrictor is titanium, hollow, rectangular frame with The Thelions and radii on all sides and toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.
Performance Data:
Non-clinical:
Static evaluation was performed and the strength of the device was characterized.
Intended Use:
The Theken Large Cement Restrictor is designed to occlude the medullary canal before the introduction of acrylic cement during surgeries such as total hip arthroplasty, as well as prevent cement from flowing down the diaphysis thereby facilitating cement pressurization. The Theken Large Cement Restrictor is NOT intended for any spinal indications.
Substantial Equivalence:
Signus Medizintechnik GmbH Rabea™ Cement Restrictor Device (K990345) Medtronic Sofamor Danek Titanium Cement Restrictor Device (K003718)
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes forming its wing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2001
Mr. Randy Theken Director Theken Surgical, LLC 1100 Nola Avenue Barberton, Ohio 44203
Re: K012462
Trade/Device Name: Theken Large Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: July 31, 2001 Received: August 1, 2001
Dear Mr. Theken:
We have reviewed your Section 510(k) premarket 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 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:
WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.
THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.
2
Page 2 - Mr. Randy Theken
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,
Bernard E. Statland, M.D.,Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510 (k) Number: K012462
Device Name: Theken Sement Restrictor
-
- Indications for Use:
The Theken Large Cement Restrictor is designed to occlude the medullary canal before the introduction of acrylic cement during surgeries such as total hip arthroplasty, as well as prevent cement from flowing down the diaphysis thereby facilitating cement pressurization. The Theken Large Cement Restrictor is NOT intended for any spinal indications.
- Indications for Use:
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (per 21 CFR 801.109) |
OR
| Over-The-Counter Use ______ | |
|---|---|
| (Optional Format 1/2/96) |
for Mark N Millman
(Division Sign-Off)
Division of General Restorative and Neurological Devices
| 510(k) Number | K012462 |
|---|---|
| --------------- | --------- |