(10 days)
The indications for the Ascent™ Anterior Stabilized Tibial Bearings are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is to be used with bone cement.
The Ascent™ Anterior Stabilized Tibial Bearings are manufactured from ArCom®, an ultra-high molecular weight polyethylene (UHMWPE). The anterior stabilized tibial bearings are available in varying thicknesses and widths. The Ascent™ Anterior Stabilized Tibial Bearings are used in conjunction with the Ascent™ Primary Femoral Components.
This document states that no clinical testing was provided as a basis for substantial equivalence for the Ascent™ Anterior Stabilized Tibial Bearings.
Therefore, the following information regarding acceptance criteria and a study proving the device meets those criteria cannot be provided from the given text:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications used to establish ground truth
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document explicitly states: "Non-Clinical Testing: Engineering Justifications determined that the Ascent™ Anterior Stabilized Tibial Bearings presented no new risks and were, therefore, substantially equivalent to the predicate device. Clinical Testing: No clinical testing was provided as a basis for substantial equivalence."
{0}------------------------------------------------
AUG 1 5 2002
KO22586
BIOMET
CORPORATE HEADQUARTERS
SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant or Sponsor: | Biomet Orthopedics, Inc.P.O. Box 587Warsaw, IN 46581-0587 |
|---|---|
| Contact Person: | Dalene T. BinkleyTelephone: (574) 267-6639 |
| Proprietary Name: | Ascent™ Anterior Stabilized Tibial Bearings |
Tibial Bearing Common Name:
Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (21 CFR 888.3560)
Device Classification: Class II
Legally Marketed Device to which Substantial Equivalence is Claimed: Ascent™ Primary Lipped Tibial Bearing (K982869).
Device Description: The Ascent™ Anterior Stabilized Tibial Bearings are manufactured from ArCom®, an ultra-high molecular weight polyethylene (UHMWPE). The anterior stabilized tibial bearings are available in varying thicknesses and widths.
The Ascent™ Anterior Stabilized Tibial Bearings are used in conjunction with the Ascent™ Primary Femoral Components.
Indications for Use: The indications for the Ascent™ Anterior Stabilized Tibial Bearings are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Summary of Technologies: The Ascent™ Anterior Stabilized Tibial Bearings -the materials, design, sizing, and indications are similar or identical to the predicate devices.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581 0587
SHIPPING ADDRESS 56 E Bell Drive Warsaw, IN 46582
मि
000054
OFFICE 219 267 (6630 FAX 219 267 81 37
E-MAII. bromerco bromet com
{1}------------------------------------------------
Non-Clinical Testing: Engineering Justifications determined that the Ascent™ Anterior Stabilized Tibial Bearings presented no new risks and were, therefore, substantially equivalent to the predicate device.
Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.
ﻪ ﺳﻤ
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .
AUG 1 5 2002
Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K022586
Trade/Device Name: Ascent™ Anterior Stabilized Tibial Bearings Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: July 11, 2002
Dear Ms. Binkley:
Received: August 5, 2002
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) 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.
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.
{3}------------------------------------------------
Page 2 – Ms. Dalene T. Binkley
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 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,
Mark McMullen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
ﻪ ﺳﯿﻤﻪ
510 (k) NUMBER (if KNOWN): ___ KOZZ 586
DEVICE NAME: Ascent™ Anterior Stabilized Tibial Bearings.
INDICATIONS FOR USE:
The indications for the Ascent™ Anterior Stabilized Tibial Bearings are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
This device is to be used with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
く Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Mark A. Milkerson
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_
060066
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.