(57 days)
K 936127, K 891445
Not Found
No
The description focuses on a mechanical device for centralizing a hip stem and contains no mention of AI or ML terms or concepts.
No.
The device is described as centralizing a femoral stem, which is a mechanical function related to the implantation of another device (a hip stem) and does not directly provide therapy for a disease or condition.
No
The device is described as a mechanical centralizer for a femoral stem during hip surgery, not a device used to identify a medical condition or disease.
No
The device description explicitly states it is a "molded acrylic device" and describes its physical components ("three wing-like projections"), indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Exeter II Distal Centralizer is a physical device implanted inside the body during surgery to help position a hip stem. It does not perform any tests on bodily samples.
The description clearly indicates it's a surgical implant used to centralize a femoral stem within the intramedullary canal. This is a mechanical function performed in vivo (within the living body), not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Exeter II Distal Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal. The Distal Centralizer is intended to be used with bone cement.
Product codes
JDI
Device Description
The Exeter II Distal Centralizer is a molded acrylic device that is fitted to the distal portion of a hip stem and used to centralize the stem within the femoral canal.
The centralizer's design consists of three wing-like projections that extend outwards from the base of the centralizer. These projections contact the walls of the femoral canal, centralizing the hip stem within the canal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral canal
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)
K 936127, K 891445
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
DEC 23 1997
Proprietary Name: Distal Centralizer, Exeter II Hip System
Common Name: Centralizer, Hip Stem
Classification Name and Reference: 21 CFR 888.3350 Prosthesis, Hip, Semi-Constrained, Metal/Polymer
Proposed Regulatory Class: Class II
Device Product Code: JDI
For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 10-24-97
The Exeter II Distal Centralizer is a molded acrylic device that is fitted to the distal portion of a hip stem and used to centralize the stem within the femoral canal.
The centralizer's design consists of three wing-like projections that extend outwards from the base of the centralizer. These projections contact the walls of the femoral canal, centralizing the hip stem within the canal.
The substantial equivalence of the centralizer is based on an equivalence in intended use, design, materials, operational principles, and relative indications and contraindications to Howmedica's currently marketed centralizers. These include the Definition Hip System centralizer (K 936127), and the currently marketed Exeter II Distal Centralizer (K 891445).
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 1997
Mr. Frank Maas Manager, Requlatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
K974054 Re: Trade Name: Distal Centralizer, Exeter II Hip System Regulatory Class: II Product Code: JDI Dated: October 24, 1997 Received: October 27, 1997
Dear Mr. Maas:
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 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 (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. ಗಿ 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 regulation (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 regulation may result in requlatory action. In addition, FDA may publish further announcements 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. Frank Maas
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,
Celia M. Whitten, Ph
elia 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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Indications for Use
510(k) Number (if known): K974054
Device Name: Distal Centralizer, Exeter II Stem
Indications for Use:
The Exeter II Distal Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal. The Distal Centralizer is intended 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)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-Off) Division of General Restorative 510(k) Number