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K Number
K973453
Device Name
TORNIER CEMENT RESTRICTOR
Manufacturer
TORNIER
Date Cleared
1997-12-09

(89 days)

Product Code
JDI,87L
Regulation Number
888.3350
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
N/A
Predicate For
K061824
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. Total Shoulder Arthroplasty
    1. Total Hip Arthroplasty
    1. Intramedullary Occlusion
    1. Cement Pressurization
Device Description

Not Found

AI/ML Overview

The provided text is a summary of safety and effectiveness information for the Tornier Cement Restrictor, submitted as a premarket notification (510(k)) to the FDA. It does not contain information about acceptance criteria for a device's performance, nor does it describe any study proving the device meets particular acceptance criteria.

The document primarily focuses on:

  • Device Identification: Name (Tornier Cement Restrictor), common name (Canal Plug, Cement Restrictor), classification name (Cement Obturator).
  • Regulatory Classification: Class II device under 21 CFR §878.3300 (Surgical mesh), product code 87LZN.
  • Intended Use/Indications For Use: Total Shoulder Arthroplasty, Total Hip Arthroplasty, Intramedullary Occlusion, Cement Pressurization.
  • Regulatory Correspondence: An FDA letter confirming substantial equivalence to devices marketed prior to May 28, 1976.
  • General Controls: Mentions requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Therefore, I cannot provide the requested information from the given text as it does not contain details regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes, data provenance, or study design for test sets.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication method.
  5. MRMC comparative effectiveness study, including effect size.
  6. Standalone algorithm performance.
  7. Type of ground truth used (pathology, outcomes data, etc.).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

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K9734/5=

ummary of Safety and tiveness Information Premarket Notification, Section 510(k)

ornier S.A.

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

  • Device Name: 1.
    Tornier Cement Restrictor Trade Name:

Canal Plug, Cement Restrictor Common Name:

Classification Name: Cement Obturator

  • Establishment Name & Registration Number: 2.
    Tornier S.A. Name:

8020756 Number:

  • Classification: 3.
    Cement Obturator, 21 CFR, §878.3300

& 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 interiod mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II.

Device Class: Class II

Classification Panel: Orthopaedic

Product Code: 87LZN

  • Special Controls: 4.
    Not applicable to this device.

    1. Labeling:
      IMPORTANT: The implantation of a joint prosthesis requires a knowledge of anatomy, biomechanics and reconstructive surgery of the locomotive apparatus and may be performed only by a qualified surgeon. The surgeon must operate in accordance with current information on the state of scientific progress and the art of surgery.

Federal (United States) Law restricts this device to sale, distribution and use by or on the order of a physician only.

Warnings and cautions: Never re-use an implant, even if it is in perfect condition. Never resterilize an implant.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1997

Mr. David W. Schlerf ·Buckman Company, Inc. Representing Tornier S.A. 1000 Burnett Avenue, Suite 450 94520 Concord, California

K973453 Re : Tornier Cement Restrictor Requlatory Class: II Product Codes: JDI and FTM Dated: August 20, 1997 Received: September 11, 1997

Dear Mr. Schlerf:

We have reviewed your Section 510(k) 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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David W. Schlerf

This letter will allow you to begin marketing your device as described in your 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 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
facolleto

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page .Ol
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510(k) Number (if known):
K973453

Device Name: Tornier Cement Restrictor

Indications For Use:

)

3

)

)

J

    1. Total Shoulder Arthroplasty
    1. Total Hip Arthroplasty
    1. Intramedullary Occlusion
    1. Cement Pressurization

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General Ked Prairie Devices 73453 510(k) Number Prescription Use × OR Over-The-Counter Use __ (Per 21 CFR 801.109)

(Optional format 1-2-96)

Cement.doc

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.