(26 days)
Previously cleared devices
Not Found
No
The description focuses on the physical design and material of a bone cement restrictor, with no mention of AI or ML capabilities.
No
The device is described as a cement restrictor used in orthopedic surgeries to contain bone cement, not to treat a disease or condition directly.
No
Explanation: The device description states its purpose is to "contain bone cement" and its "exterior surface...has teeth to prevent the device from migrating." Its intended use is in "orthopedic surgeries involving the femoral canal, tibia, or the humerus." These descriptions indicate it is a surgical implant designed for a therapeutic purpose, not for diagnosing a condition or disease. There is no mention of it collecting data, analyzing images, or providing diagnostic information.
No
The device description clearly states it is a physical implantable device made of PEEK-OPTIMA® with a specific geometry and features, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use in orthopedic surgeries involving the femoral canal, tibia, or humerus. This is a surgical implant used in vivo (within the body) during a procedure.
- Device Description: The description details a physical implant designed to contain bone cement within a bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVDs are typically used in laboratories or point-of-care settings to analyze biological samples. This device is a surgical tool/implant used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The Life Spine Cement Restrictor is intended for use in orthopedic surgeries involving the femoral canal, tibia, or the humerus.
This device is NOT intended for use in any spinal indications or acetabular cup surgeries. The safety and effectiveness of this device for implantation in the spine has not been established.
The Life Spine Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus.
This device is not intended for spinal indications or acetabular cup surgeries. The safety and effectiveness of this device when implanted in the spine have not been established.
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
Product codes (comma separated list FDA assigned to the subject device)
JDK
Device Description
The device is a straight or tapered hollow box with a fenestrated surface on many sides. The geometry is designed to contain bone cement. The exterior surface of the device has teeth to prevent the device from migrating from the desired location. The device is manufactured from PEEK-OPTIMA®. The device is made in a variety of sizes. The responsible surgeon will determine the correct size of the device in accordance with the anatomical size of the individual patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral canal, tibia, humerus, femur
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)
This is designated as a non-load bearing Class II device under CFR 21 878.3300 and no mechanical tests are required.
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.
Previously cleared devices
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
Image /page/0/Picture/0 description: The image shows the logo for Life Spine. The words "Life Spine" are written in a bold, sans-serif font. A curved line is underneath the word "Spine". A registered trademark symbol is to the right of the word "Spine".
K061698 P& LOF Z
| Special 510(k) Summary of Safety and Effectiveness | ||
|---|---|---|
| 510(k) Summary - Life Spine Cement Restrictor | ||
| Submitted By: | Life Spine | |
| 2400 Hassell Road, Suite 370 | ||
| Hoffman Estates, IL 60195 |
Telephone: 847-884-6117
Fax: 847-884-6118 | JUL 1 2 2006 |
| 510(k) Contact: | Erin Malloy
Life Spine
2400 Hassell Road, Suite 370
Hoffman Estates, IL 60195 | |
| Date Prepared: | June 15, 2006 | |
| Trade Name: | Life Spine Cement Restrictor | |
| Common Name: | Cement Restrictor | |
| Classification: | Prosthesis, Surgical Mesh
CFR 878.3300
Class II | |
| Device Product Code: | JDK | |
| Predicate Device: | Previously cleared devices | |
Device Description:
The device is a straight or tapered hollow box with a fenestrated surface on many sides. The geometry is designed to contain bone cement. The exterior surface of the device has teeth to prevent the device from migrating from the desired location. The device is manufactured from PEEK-OPTIMA®. The device is made in a variety of sizes. The responsible surgeon will determine the correct size of the device in accordance with the anatomical size of the individual patient.
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
1
Image /page/1/Picture/0 description: The image shows the words "Life Spine" in a bold, sans-serif font. The word "Life" is in a larger font size than the word "Spine". There is a curved line underneath the word "Spine", and the registered trademark symbol is to the right of the word "Spine".
Intended Use of the Device:
The Life Spine Cement Restrictor is intended for use in orthopedic surgeries involving the femoral canal, tibia, or the humerus.
This device is NOT intended for use in any spinal indications or acetabular cup surgeries. The safety and effectiveness of this device for implantation in the spine has not been established.
Material:
The Life Spine Cement Restrictor is manufactured from PEEK-OPTIMA® according to ASTM F 2026-02.
Performance Data:
This is designated as a non-load bearing Class II device under CFR 21 878.3300 and no mechanical tests are required.
Substantial Equivalence:
The Life Spine Cement Restrictor was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three abstract shapes that resemble birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2006
Life Spine LLC % Ms. Erin Malloy Project Engineer 2400 Hassell Road, Suite 370 Hoffman Estates, Illinois 60195
Re: K061698
Trade/Device Name: Life Spine Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: June 15, 2006 Received: June 16, 2006
Dear Ms. Malloy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 10 mo been in 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.
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.
3
Page 2 - Ms. Erin Malloy
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buell MD
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Life Spine. The words "Life Spine" are written in a bold, sans-serif font. A curved line is underneath the word "Spine". The registered trademark symbol is next to the word "Spine".
KØ61698
Indications for Use
510(k) number (if known): ________
Device Name: Life Spine Cement Restrictor
The Life Spine Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus.
This device is not intended for spinal indications or acetabular cup surgeries. The safety and effectiveness of this device when implanted in the spine have not been established.
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
Prescription Use x (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)
K061698 Barbara Buehno
(Divis Division of General, Restor and Neurological Devices
510(k) Number K061196