SKELITE RESORBABLE CEMENT RESTRICTOR

• K Number: K051836
• Device Name: SKELITE RESORBABLE CEMENT RESTRICTOR
• Manufacturer: MILLENIUM BIOLOGIX, INC.
• Date Cleared: 2005-11-21 ( 138 days)
• Product Code: JDK
• Regulation Number: 878.3300

Intended Use

The Skelite™ Resorbable Cement Restrictor is intended to be used in orthopaedic surgeries, such as those involving the femoral and tibia canals in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.

Device Description

Not Found

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical, resorbable cement restrictor for orthopedic surgery and contains no mention of software, algorithms, AI, or ML.

Therapeutic

No
The device is described as a "Resorbable Cement Restrictor" used in orthopaedic surgeries, which functions as a tool or component within a surgical procedure rather than a device designed to diagnose, treat, or prevent disease or injury itself.

Diagnostic

No
Explanation: The device, the Skelite™ Resorbable Cement Restrictor, is described as being "intended to be used in orthopaedic surgeries, such as those involving the femoral and tibia canals in hip stem and total knee replacement." This indicates a surgical tool or implant, not a device used for detection, diagnosis, or identifying a medical condition.

SaMD (Software as a Medical Device)

No

The device description and intended use clearly indicate a physical, resorbable cement restrictor used in orthopedic surgery, not a software application.

IVD (In Vitro Diagnostic)

Based on the provided information, the Skelite™ Resorbable Cement Restrictor is not an IVD (In Vitro Diagnostic) device.

Here's why:

• Intended Use: The intended use clearly states it's for use in orthopedic surgeries involving the femoral and tibia canals. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
• Device Description: While the description is "Not Found," the intended use is the primary indicator.
• Other Sections: The absence of information about image processing, AI/ML, input imaging modality, training/test sets, performance studies, and key metrics further supports that this is not an IVD. These sections are typically relevant for devices that analyze biological samples or medical images.

Therefore, the Skelite™ Resorbable Cement Restrictor is a surgical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Skelite™ Resorbable Cement Restrictor is intended to be used in orthopaedic surgeries, such as those involving the femoral and tibia canals in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.

Product codes

JDK

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

femoral and tibia canals

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)

Not Found

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.

Not Found

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

Regulation Number and Section

§ 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.

Summary

0

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2005

Millenium Biologix, Inc. Robert Schiff, Ph.D., RAC, CQA (ASQ) President Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006

Re: K051836

Trade/Device Name: Skelite™ Resorbable Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: October 27, 2005 Received: November 1, 2005

Dear Dr. Schiff:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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 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 labeling and also as a Warning on the product label:

THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. WARNING:

THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

1

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.

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 Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Donna Roe Tillman, Ph.D., M.B.A.

onna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Not assigned yet

Device Name:

Skelite™ Resorbable Cement Restrictor

Indications for Use:

The Skelite™ Resorbable Cement Restrictor is intended to be used in orthopaedic surgeries, such as those involving the femoral and tibia canals in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.

Prescription Use Var

Over-The-Counter Use: No

(Per 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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the-line-breaker

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_K 051836