(90 days)
Not Found
No
The device description and intended use clearly describe a mechanical, non-software-driven implant. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is a cement restrictor used during orthopedic surgeries to manage cement, not a therapeutic device designed to treat or cure a disease or condition. Its function is to restrict cement, which is a procedural aid, not a direct therapeutic action on the patient.
No
This device, the Theken Small Cement Restrictor, is described as a physical component (a "cement restrictor") used in orthopaedic surgeries to manage cement during procedures like total knee replacement. Its function is to restrict cement, not to gather information, analyze patient data, or identify a medical condition.
No
The device description explicitly states it is a "hollow, titanium, and rounded rectangular frame," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This includes tests for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly states the device is a physical implant (a cement restrictor) used during orthopedic surgery to restrict cement flow. It is used in the body, not to test samples from the body.
The device's function is mechanical and surgical, not diagnostic based on analyzing biological specimens.
N/A
Intended Use / Indications for Use
The Theken Small Cement Restrictor is intended for use as a cement restrictor in orthopaedic surgeries such as those involving the tibial plateau in total knee replacement. The Theken Small Cement Restrictor is NOT intended for any spinal indications.
Product codes (comma separated list FDA assigned to the subject device)
JDK
Device Description
The Theken Small Cement Restrictor is a hollow, titanium, and rounded rectangular frame with fenestrations 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
tibial plateau
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopaedic surgeries
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): 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
§ 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
Theken Small Cement Restrictor
510 (k) Summary
- Theken Surgical Company: 1100 Nola Ave. Barberton, OH 44203
Theken Small Cement Restrictor Trade Name:
Classification: JDK 21CFR878.3300. Surgical Mesh. Class II.
Description:
The Theken Small Cement Restrictor is a hollow, titanium, and rounded rectangular frame with fenestrations on all sides and toothed spikes on opposite The device is intended to be used in conjunction with standard PMMA sides. cement.
Performance Data:
Non-clinical:
Static evaluation was performed and the strength of the device was characterized.
Intended Use:
The Theken Small Cement Restrictor is intended for use as a cement restrictor in orthopaedic surgeries such as those involving the tibial plateau in total knee replacement. The Theken Small Cement Restrictor is NOT intended for any spinal indications.
Substantial Equivalence:
Signus Medizintechnik GmbH Rabea™ Cement Restrictor Device (K990345)
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three overlapping wave-like shapes, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2001
Mr. Randy Theken Director Theken Surgical, LLC 1100 Nola Avenue Barberton, Ohio 44203
Re: K012278
Trade/Device Name: Theken Small Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: July 18, 2001 Received: July 19, 2001
Dear Mr. Theken:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your over over seening 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 mendments, or to devices that have been reclassified in accordance with the provisions of the Amendins, of to Gevroos and Cosmetic Act (Act) that do not require approval of a premarket approval I cadial I ood, Drag, and over, therefore, market the device, subject to the general controls (1 MA) application: "Four may, misstions described below. The general controls provisions of the provisions of the Acrains the minutelis tration, 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 The Office of Derice Draintended use not identified in the proposed labeling and that such use device with be used for an accordance with Section 513(i)(1)(E) of the Act, the following Court cause natin. "There 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 If your device is elassinos (controls. Existing major regulations affecting your device can may be subject to such additions, 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 i loast of advised that I Driving that your device complies with other requirements of the Act that I Dr Hab Intact a cond regulations administered by other Federal agencies. You must or any I odolar statutes and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Part 607); mooning (21 CFR Part 820); and if applicable, the electronic rorth in the qualis) af everyisions (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 The I Dri Iniania of sacceanna expermits 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. r lease note and the ace 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 additionally 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: K012278
Device Name: Theken Small Cement Restrictor
-
- Indications for Use:
The Theken Small Cement Restrictor is intended for use as a cement restrictor in orthopaedic surgeries such as those involving the tibial plateau in total knee replacement. The Theken Small Cement Restrictor is NOT intended for any spinal indications.
- Indications for Use:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1/2/96)
Mark N Milliken
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012278