(88 days)
Not Found
No
The document describes a mechanical hip replacement system and does not mention any AI or ML components or functionalities.
Yes
The device is a hemi-hip replacement system, which is used to treat medical conditions affecting the hip, clearly indicating a therapeutic purpose.
No
Explanation: The device described is a hemi hip replacement system intended for surgical implantation to treat various hip conditions, not to diagnose them. Its purpose is therapeutic, replacing damaged anatomy rather than identifying a medical condition.
No
The device description clearly states it is a "modular hemi-hip replacement system, which is composed of a metal stem and neck part ("stem") with an expandable femoral head in various dimensions from metal or Alumina ceramic". This describes physical hardware components, not software.
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.
- Device Description and Intended Use: The provided information clearly describes a surgical implant used for hip replacement. It is a physical device implanted into the body to replace damaged bone and joint structures.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its purpose is purely therapeutic and structural.
Therefore, based on the provided information, the Fixion Unipolar Modular Hemi-Hip System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Fixion Unipolar Modular Hemi-Hip System is intended for The Fixton 'Ompsemented use as a hemi hip replacement in cases of:
- Femoral head/neck fractures or non-unions
- Aseptic necrosis of the femoral head/neck
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal acetabular involvement
Product codes
KWY
Device Description
The Fixion UH is a modular hemi-hip replacement system, which is composed of a metazie relition from in various dimensions from metal or Alumina ceramic for use during partial hip replacement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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
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Summary of Performance Studies
The performance characteristics of the Fixion UH have been tested and found to meet the specifications through a series of bench tests.
The Fixion UH conforms to the requirements of ISO 7206-8 (1995) "Implants for Surgery Partial and Total Hip Joint Prostheses - Part 8: Endurance Performance of Stemmed Femoral Components with Application of Torsion." The Fixion UH also conforms to FDA Draft Guidance Documents: Guidance Document for Femoral Stem Prostheses (1995) and Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components (1995). In addition, the Fixion UH conforms to FDA Draft Guidance Document for the Preparation of Premarket Notification for Ceramic Ball Hip Systems (1995).
Key Metrics
Not Found
Predicate Device(s)
Depuy Orthopeadics' Elite® Modular Hip System, S-ROM Total Hip System, Disc-O-Tech's Fixion™ Interlocking PF Intramedullary Nailing System, Link America, Inc.'s Link® Reconstruction Hip, Smith and Nephew's Biolox® Alumina Ceramic Femoral Head
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.
0
510 (K) Summary
Disc-O-Tech Medical Technologies Ltd.'s Fixion™ Unipolar Modular Hemi-
8 2002 MAR
Hip System
K014072
page 1 of 2
Company Name Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St. Herzlia, 46728, Israel
Submitter's Name and Contact Person
Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, NW Washington, DC 20004 Tel.: 202-637-5794 Fax: 202-637-5910
Date Prepared
March 6, 2002
Trade/Proprietary Name
Fixion™ Unipolar Modular Hemi-Hip System ("Fixion UH")
Classification Name
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
Predicate Devices
The Fixion UH intended use, materials and accessories are substantially equivalent to those used in Depuy Orthopeadics' Elite® Modular Hip System and S-ROM Total Hip System, as well as Disc-O-Tech's Fixion™ Interlocking PF Intramedullary Nailing System. The Fixion UH is also substantially equivalent to Link America, Inc.'s Link® Reconstruction Hip and to Smith and Nephew's Biolox® Alumina Ceramic Femoral Head.
Performance Standards
The Fixion UH conforms to the requirements of ISO 7206-8 (1995) "Implants for Surgery Partial and Total Hip Joint Prostheses - Part 8: Endurance Performance of Stemmed Femoral Components with Application of Torsion." The Fixion UH also conforms to FDA Draft Guidance Documents: Guidance Document for Femoral Stem Prostheses (1995) and Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components (1995). In addition, the Fixion UH conforms to FDA Draft Guidance Document for the Preparation of Premarket Notification for Ceramic
1
Ball Hip Systems (1995).
Intended Use
The Fixion Unipolar Modular Hemi-Hip System is intended for use for The Polon Chaptical use as a hemi hip replacement in case of:
- Femoral head/neck fractures or non-unions ●
- Aseptic necrosis of the femoral head/neck .
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal . acetabular involvement
K 01407d
System Description
ystem Description
The Fixion UH is a modular hemi-hip replacement system, which is composed The I Mori of I is a land neck part ("stem") with an expandable femoral of a metazie relition from in various dimensions from metal or Alumina ceramic for use during partial hip replacement.
Substantial Equivalence
The Fixion UH System has substantially equivalent intended use and indications for use as the Elite Modular Hip System and the other predicates, i.e., replacement of hips.
The performance characteristics of the Fixion UH have been tested and found to meet the specifications through a series of bench tests.
The Stem of the Fixion UH Unipolar Hemi-Hip System, like the Fixion™ PF Intramedullary Nail, is made of 316LVM Stainless Steel. The cross section of the Fixion UH stem body and the Fixion Interlocking PF Intramedullary nail is identical and circular with reinforcement bars.
Fixation of the Fixion UH Stem to the femur is further enhanced by its inflation with sterile saline similar to the Fixion PF Nail and results in the abutment of the 4 reinforcement bars to the medullary canal wall. Rotational and axial stability is aided by the shape of the Stem Neck. The inflation of the Fixion UH Stem with saline, which is a non-compressible biocompatible fluid, is identical to the cleared Fixion PF Nail and does not raise any new safety and efficacy issues.
CONFIDENTIAL
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 2002 MAR
Disc-O-Tech Medical Technologies, LTD. c/o Mr. Johnathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004
Re: K014072
Trade Name: Fixion Unipolar Modular Hemi-Hip System (Fixion UH) Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Code: KWY Date: December 3, 2001 Received: December 10, 2001
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket 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) 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 therely, maintons of the Act include requirements for annual registration, listing of devices, Condons provision 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordly in the quality by over of provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Johnathan S. Kahan, Esq.
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will anon-you're substantial equivalence of your device of your device to a legally prematicated 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 If you desire specific da rios for for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Fat 0071. Additionally, for questions on the promotion and advertising of Compilance at (301) 597 1007 First of Compliance at (301) 594-4639. Also, please note the your do roos, produced withing by reference to premarket notification™ (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Outler general mionmation on Jour versational 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 N Mckenn
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
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Disc-()-Tech Medical Technologies, Ltd. Fixion UH Unipolar Modular Hemi-Hip System 510(k)
Page 1 of 1
INDICATION FOR USE
| and the submit of the state of the same of the same of the same of the same of the status and the many of the many of the many of the many of the many of the many of the many | 510(K) Number (if known): | K014072 | ||
|---|---|---|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | --------------------------- | --------- | -- |
l'ixion Unipolar Modular Hemi-Hip System (Fixion™ UH) Device Name:
Indication for Use:
The Fixion Unipolar Modular Hemi-Hip System is intended for The Fixton 'Ompsemented use as a hemi hip replacement in cases of:
Femoral head/neck fractures or non-unions ﺳﻤ
- Aseptic necrosis of the femoral head/neck r
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip. ﺮ with minimal acetabular involvement
IP TENSE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of General. Restorative and Neurological Devices
510(k) Number:
| Prescription Use | X | OR |
|---|---|---|
| (pg 21 CFR 801.109) |
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Over the Counter Use_____________
510(k) Number .
CONFIDENTIAL
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