(88 days)
Not Found
No
The summary describes a mechanical hip prosthesis and its components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a hip prosthesis designed for implantation to alleviate severe hip pain and disability, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a hip prosthesis designed for implantation to replace hip joints. It does not perform any diagnostic functions like detecting, monitoring, or predicting diseases. Its purpose is to treat pain and disability by replacing a damaged joint.
No
The device description explicitly details physical components made of titanium and cobalt-chromium-molybdenum alloy, which are hardware. The intended use also describes implantation of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a hip joint due to various conditions affecting the femur. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and design of a physical prosthesis (femoral heads, stems, and instrumentation) intended for implantation into the human body.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnostic purposes. IVDs are used to test samples like blood, urine, or tissue.
- Anatomical Site: The device is implanted in the human femur, which is an in-vivo application, not an in-vitro (outside the body) diagnostic test.
Therefore, the Tigran TM Hip Prosthesis is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tigran TM Hip Prosthesis for total hip arthoplasty consists of three basic parts: femoral heads, femoral stems, and the instrumentation necessary for proper implantation of these components. The Tigran TM Hip Prosthesis is designed for implantation into the human femur in total or hip replacement and is indicated for the following:
-
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur
-
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis;
-
- Patients suffering from disability due to previous fusion;
-
- Patients with previously failed endoprostheses and/or total hip components in the affected extremity:
-
- Patients with acute femoral neck fractures.
This indication statement is essentially the same as the indication statement for the predicate device.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI
Device Description
The Tigran™ Femoral Prosthesis for hip arthroplasty consists of three basic parts: femoral heads, femoral stems, and the instrumentation necessary for proper implantation of these components. The femoral stem is made from Titanium Ti-6A1-4V Alloy, a high fatigue strength material with a long history of clinical use and exceptional biocompatibility. The surface of the femoral stem is prepared with a surface finish and pattern to provide optimal initial and lasting fixation in bone. The femoral stem has a collar and is modular in design, incorporating a Morse-type tapered neck and utilizing modular femoral heads. The Femoral stem is straight and with a rectangular crosssectional shape to provide optimal, rotational stability. The Tigran™ Prosthesis Femoral Stem is available in four neck sizes (short, medium, long and extra long).
The femoral head is fabricated from Cobalt-Chromium-Molybdenum Alloy and comes in three neck configurations (short, medium and long) and in one head diameter (28mm). The various neck lengths provided allow this prosthesis to fit different variations found in the human femora.
The titanium and chrome-cobalt alloy components can be used together, although they are made from dissimilar alloys. In vitro electrochemical corrosion studies have shown that no detrimental changes occur when the two alloys are coupled.
Special instruments are available to assist in mating, disassembling, and the accurate installation of the implant components.
The Tigran™ Femoral Prosthesis (femoral stem and head) may be used with any acetabular prosthesis with an articulating surface made of ultra high molecular weight polyethylene (UHMWP) and designed to be used with a 28 mm CoCrMo Alloy femoral head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human femur
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)
Non-Clinical Tests: Non-clinical mechanical testing was performed to demonstrate that the femoral stem met or exceed the appropriate testing standards / requirements
Clinical Test Results: Long-term clinical testing was performed and reported on to demonstrate the safety and performance of the Tigran™ Hip Prosthesis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
-Ponmed Limited
Confidential
Tigran 510(k)
P981117
Date of current draft 226/99
Section 16.0 510(k) Summary
510K(k) SUMMARY
SUBMITTER:
Ponmed Limited
DATE PREPARED: November 17th, 1998 Tigran™ Hip Prosthesis DEVICE NAME: CLASSIFICATION NAME: Femoral Hip Prosthesis
PREDICATE DEVICES:
The Tigran TM Hip Prosthesis is substantially equivalent to the Zimmer Versys Hip System (510(k) Number K 964769) and the DePuy Stability™ Hip System (K 915594).
Device Description:
The Tigran™ Femoral Prosthesis for hip arthroplasty consists of three basic parts: femoral heads, femoral stems, and the instrumentation necessary for proper implantation of these components. The femoral stem is made from Titanium Ti-6A1-4V Alloy, a high fatigue strength material with a long history of clinical use and exceptional The surface of the femoral stem is prepared with a surface finish and biocompatibility. pattern to provide optimal initial and lasting fixation in bone. The femoral stem has a collar and is modular in design, incorporating a Morse-type tapered neck and utilizing modular femoral heads. The Femoral stem is straight and with a rectangular crosssectional shape to provide optimal, rotational stability. The Tigran™ Prosthesis Femoral Stem is available in four neck sizes (short, medium, long and extra long).
The femoral head is fabricated from Cobalt-Chromium-Molybdenum Alloy and comes in three neck configurations (short, medium and long) and in one head diameter (28mm). The various neck lengths provided allow this prosthesis to fit different variations found in the human femora.
The titanium and chrome-cobalt alloy components can be used together, although they are made from dissimilar alloys. In vitro electrochemical corrosion studies have shown that no detrimental changes occur when the two alloys are coupled.
Special instruments are available to assist in mating, disassembling, and the accurate
000003
1
· Ponned Limited
| Confidential | Filename
Tigran 510(k) | File No.
P981112 | Date of current draft
2/26/99 |
| -------------- | --------------------------- | --------------------- | ---------------------------------- |
|---|
installation of the implant components.
The Tigran™ Femoral Prosthesis (femoral stem and head) may be used with any acetabular prosthesis with an articulating surface made of ultra high molecular weight polyethylene (UHMWP) and designed to be used with a 28 mm CoCrMo Alloy femoral head.
Intended Use:
The Tigran TM Hip Prosthesis for total hip arthoplasty consists of three basic parts: femoral heads, femoral stems, and the instrumentation necessary for proper implantation of these components. The Tigran TM Hip Prosthesis is designed for implantation into the human femur in total or hip replacement and is indicated for the following:
-
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur
-
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis;
-
- Patients suffering from disability due to previous fusion;
-
- Patients with previously failed endoprostheses and/or total hip components in the affected extremity:
-
- Patients with acute femoral neck fractures.
This indication statement is essentially the same as the indication statement for the predicate device.
Comparison to Predicate Devices:
All hip systems listed in the previous table are substantially equivalent to each other and to the Tigran TM Hip Prosthesis which are intended for cementless fixation into the intramedullary canal for pathological or degenerative conditions involving the femur and / or acetabulum. All predicate devices feature a porous or roughened surface and are modular in design. All incorporate pure titanium, a Titanium alloy, or hydroxy apetitie as a surface texture coating or interface for the femoral stem. Each has Morse-type proximal neck taper that mates with a femoral head which, in turn articulates upon the acetabular component. All predicate devices and the Tigran TM Hip Prosthesis are manufactured from metal alloys that have a history of successful clinical use in orthopedic applications.
000004
2
- Ponned Limited
| Confidential | Filename | File No. | Date of current draft |
|---|---|---|---|
| Tigran 510(k) | P981112 | 2/26/99 |
The Tigran ™ Hip Prosthesis is substantially equivalent to the Zimmer Versys Hip System (510(k) Number K 964769) and the DePuy Stability™ Hip System (K 915594).
Examination of the information pertaining to the Tigran ™ Hip Prosthesis demonstrates that this device is substantially equivalent in composition, intended use, packaging and labeling to other hip prostheses currently approved for commercial distribution in the United States by the FDA. There are no significant differences between these marketed products and our proposed device.
Summary of Non-Clinical Tests:
Non-clinical mechanical testing was performed to demonstrate that the femoral stem met or exceed the appropriate testing standards / requirements
Clinical Test Results:
Long-term clinical testing was performed and reported on to demonstrate the safety and performance of the Tigran™ Hip Prosthesis.
3
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Jeffrey R. Shideman, Ph.D. Ponmed Limited 7307 Glouchester Drive Edina, Minnesota 55435
Re: K984492 Tigran™ Hip Prosthesis Trade Name: Regulatory Class: II Product Codes: LPH and JDI Dated: November 17, 1998 December 17, 1998 Received:
Dear Dr. Shideman:
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 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. A 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 requlation 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 requlations.
4
Page 2 - Jeffrey R. Shideman, Ph.D.
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. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
5
Page / of /
510 (k) NUMBER (IF KNOWN): K984492
DEVICE NAME: Tigran Hip Prosthesis
INDICATIONS FOR USE:
Indications for Use Statement
-
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur
- 2). Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis;
-
- Patients suffering from disability due to previous fusion;
-
- Patients with previously failed endoprostheses and/or total hip components in the affected extremity;
-
- Patients with acute femoral neck fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 11/1 (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
to coely
(Division Sign-Off)
Division of General Restorative Devices K984492
510(k) Number __