(63 days)
Not Found
No
The description focuses on mechanical components and a saline inflation mechanism, with no mention of AI/ML terms or functions.
Yes
The device is a hemi-hip replacement system, implants a medical device, and is used to treat various conditions of the hip, such as fractures, necrosis, and arthritis.
No
The device is a hemi-hip replacement system, used as a prosthetic implant to replace parts of the hip joint. Its intended use and described components are for surgical intervention and replacement, not for diagnosing medical conditions.
No
The device description explicitly lists physical components such as implants (stainless steel stem and head ball), an instrumentation set (including tools and accessories), and an inflation device (a pump). These are all hardware components, not software.
Based on the provided information, the Fixion® MH System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This system is an implantable device used for surgical replacement of parts of the hip joint.
- The intended use and device description clearly indicate a surgical implant and associated tools. There is no mention of analyzing biological samples or providing diagnostic information.
- The device description focuses on mechanical components and surgical procedures.
Therefore, the Fixion® MH System falls under the category of a surgical implant/prosthesis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fixion® MH System is intended for cemented or non-cemented use as a hemi-hip replacement. It is indicated for use in cases of:
-
Femoral head and/or neck fractures or non-unions;
- Aseptic necrosis of the femoral head and/or neck; A
- Osteo-, Rheumatoid-, and/or Post-traumatic arthritis of the hip, with A minimal acetabular involvement.
Product codes
KWL
Device Description
The Fixion® MH System is a modular hemi-hip system, which consist of the following main components:
- Implants (stainless steel), including the stem and head ball. The stem is the 1. femoral diaphyseal component. It consists of an expandable stem body and a neck part. The unipolar head ball is the prosthesis hip component that articulates within the acetabulum.
- The Instrumentation Set is a set of accessories, including pre-operative 2. tools, femoral canal preparation tools and accessories such as the stem insertion handle, inflation adapter, screwdriver for stem cap insertion and devices for implant removal.
- The Inflation Device is a pump, which rotation of its handle delivers saline 3. into the stem. This action causes the expansion of the stem and its abutment to the bone medullary cavity. The pump pressure gauge indicates the inflation pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral head and/or neck, hip, acetabular
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
MAY 3 0 2003
Disc-O-Tech Medical Technologies, Ltd. Fixion® Unipolar Modular Hemi-Hip System
510(K) Summary
KO30972
Disc-O-Tech Medical Technologies Ltd. Fixion® Unipolar Modular Hemi-Hip System (Fixion® MH) -10/16 mm stem body; 12 mm stem neck; 316L stainless steel head ball.
Company Name and Address
Disc-O-Tech Medical Technologies Ltd. 3 Hasadnaot St. Herzelia 46728 Israel
Submitter's Name and Contact Person
Hila Wachsler-Avrahami Disc-O-Tech Medical Technologies Ltd. 3 Hasadnaot St. Herzelia 46728 Israel Tel .: + 972 9 9511511 Fax .: + 972 9 9548939
Date Prepared
March 26, 2003
Trade/Proprietary Name
Fixion® Unipolar Modular Hemi-Hip System (Fixion® MH)
Classification Name
Prosthesis, Hip, Hemi-, Femoral, Metal 21 CFR § 888.3360 Class II
1
Predicate Devices
-
- Fixion® Unipolar Modular Hemi-Hip System (K014072) by Disc-O-Tech.
Performance Standards
The following standards were used:
-
- ISO 7206-1 (1995): Implants for Surgery Partial and Total Hip Joint Prostheses - Part 1: Classification and Description of Dimensions.
-
- ISO 7206-4 (Draft, 1999): Implants for Surgery Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties of Stemmed Femoral Components.
-
- 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.
-
- Guidance Document for Femoral Stem Prostheses (Draft), ORDB/DGRD/CDRH/FDA, August 1, 1995.
-
- Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components (Draft), ORDB/DGRD/CDRH/FDA, May 1, 1995.
-
- ASTM F138-2000: Standard Specification for Stainless Steel Bar and Wire for Surgical Implants.
-
- ASTM F565-2000: Standard Practice for Care and Handling of Orthopedic Implants and Instruments.
Intended Use
The Fixion® MH System is intended for cemented or non-cemented use as a hemi-hip replacement. It is indicated for use in cases of:
-
Femoral head and/or neck fractures or non-unions;
- Aseptic necrosis of the femoral head and/or neck; A
- Osteo-, Rheumatoid-, and/or Post-traumatic arthritis of the hip, with A minimal acetabular involvement.
2
System Description
The Fixion® MH System is a modular hemi-hip system, which consist of the following main components:
- Implants (stainless steel), including the stem and head ball. The stem is the 1. femoral diaphyseal component. It consists of an expandable stem body and a neck part. The unipolar head ball is the prosthesis hip component that articulates within the acetabulum.
- The Instrumentation Set is a set of accessories, including pre-operative 2. tools, femoral canal preparation tools and accessories such as the stem insertion handle, inflation adapter, screwdriver for stem cap insertion and devices for implant removal.
- The Inflation Device is a pump, which rotation of its handle delivers saline 3. into the stem. This action causes the expansion of the stem and its abutment to the bone medullary cavity. The pump pressure gauge indicates the inflation pressure.
Substantial Equivalence
The Fixion® MH 10/16 stem (with a neck width of 12 mm) and the Fixion® MH 316L stainless steel head balls are substantially equivalent to the cleared stem and head balls of the Fixion® MH System (K014072):
- They have the same intended use and indications for use; ું.
- ું જ They incorporate the same basic design;
- They have the same operating principles; જુન
- ું જ They have the same fixation method;
- ું જ They are packed and sterilized using the same materials and processes.
The added components are made of the same materials as the cleared Fixion® MH stem.
In addition, the dimensions of the added Fixion® MH stem body, neck and head balls are within the range of sizes of other cleared, marketed systems.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2003
Ms. Hila Wachsler-Avrahami Regulatory Affairs Disc-O-Tech Medical Technologies Ltd. 3 Hasadnaot Street Herzelia Israel 46728
Re: K030972
Trade/Device Name: Fixion® Unipolar Modular Hemi-Hip System (Fixion® MH) Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: KWL Dated: April 29, 2003 Received: May 1, 2003
Dear Ms. Wachsler-Avrahami:
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
4
Page 2 - Ms. Lori Glastetter
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. 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), please contact the Office of Compliance at (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milliman
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
5
Indication for Use
510(K) Number (if known): _ Ko3 o972
Device Name: Fixion® Unipolar Modular Hemi-Hip System (Fixion® MH)
Indication for Use: The Fixion® MH System intended for cemented or noncemented use as a hemi-hip replacement. It is indicated for use in cases of:
- Femoral head and/or neck fractures or non-unions; A
- Aseptic necrosis of the femoral head and/or neck; A
- 八 Osteo-, Rheumatoid-, and/or Post-traumatic arthritis of the hip, with minimal acetabular involvement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over the Counter Use |
|---|---|---|
| (per 21 CFR 801.109) |
[Signature]
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K030972 |
|---|---|
| --------------- | --------- |