(25 days)
No
The document describes a hip implant system made of traditional materials and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device, an Implex Hip System, is designed to treat various hip problems, including degenerative arthritis, avascular necrosis, fractures, and failed hip replacements, which are conditions that require therapeutic intervention.
No
Explanation: The device described is an acetabular cup, which is an implant used in hip replacement surgery. Its intended use is to treat various hip problems and injuries. It does not perform any diagnostic functions or analyze patient data to determine a medical condition.
No
The device description clearly states it is a physical implantable device made of metal and polyethylene, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a surgical implant for treating various hip conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and construction of an artificial hip joint component. This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to replace or support a damaged hip joint.
N/A
Intended Use / Indications for Use
The use of the Implex Hip System is indicated for: a) Severely disabled joints as a result of degenerative arthritis or avascular necrosis, b) Secondary revision of a previously unsuccessful femoral component or total hip replacement, c) Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results, d) Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be achieved, e) Non-union or femoral neck or head fractures, f) Salvage of a failed primary or secondary total or hemi hip. The Trabecular Metal Monoblock Acetabular Cup is Conclusion: substantially equivalent to the identified predicate devices.
Product codes
LPH, JDI
Device Description
The Trabecular Metal Monoblock Acetabular Cup is manufactured from Trabecular Metal (Hedrocel Porous Tantalum), titanium alloy (Ti-6Al-4V), and direct compression molded ultra-high molecular weight polyethylene (UHMWPE). It is available with an ID of 28 mm, an OD range of 48 - 70 mm in 2 mm increments, and possesses a hybrid 0 - 10-degree face angle. The device utilizes the same instrumentation and surgical protocol as the Hedrocel and Trabecular Metal Monoblock Cups (K964509 and K003181). These acetabular devices are intended for use with Zimmer and Implex Components as described in K003181.
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
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
§ 888.3358 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
Implex Corp.
JUL 1 2 2002 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| The Trabecular Metal Monoblock Cup | |
|---|---|
| Submitter Name: | Implex Corp. |
| Submitter Address: | 80 Commerce Drive |
| Allendale, New Jersey 07401-1600 | |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | (201) 818 - 1800 |
| Fax Number: | (973) 829 - 0825 |
| Date Prepared: | June 12, 2002 |
| Device Trade Name: | The Trabecular Metal Monoblock Acetabular Cup |
| Device Common | |
| Name: | Acetabular Prosthesis |
| Classification Number | |
| and Name: | 21 CFR § 888.3350 and 888.3358, Hip joint metal/polymer |
| semi-constrained cemented prosthesis. Hip joint metal/polymer | |
| semi-constrained porous cementless prosthesis. | |
| Substantial | |
| Equivalence: | The term "substantial equivalence" as used in this |
| 510(k) notification is limited to the definition of | |
| substantial equivalence found in the Federal Food, | |
| Drug and Cosmetic Act, as amended and as applied | |
| under 21 CFR 807, Subpart E under which a device | |
| can be marketed without premarket approval or | |
| reclassification. A determination of substantial | |
| equivalency under this notification is not intended to | |
| have any bearing whatsoever on the resolution of | |
| patent infringement suits or any other patent matters. | |
| No statements related to, or in support of substantial | |
| equivalence herein shall be construed as an | |
| admission against interest under the US Patent Laws | |
| or their application by the courts. | |
| Device Description: | The Trabecular Metal Monoblock Acetabular Cup is |
| manufactured from Trabecular Metal (Hedrocel Porous | |
| Tantalum), titanium alloy (Ti-6Al-4V), and direct | |
| compression molded ultra-high molecular weight | |
| polyethylene (UHMWPE). It is available with an ID of 28 | |
| mm, an OD range of 48 - 70 mm in 2 mm increments, and | |
| possesses a hybrid 0 - 10-degree face angle. The device | |
| utilizes the same instrumentation and surgical protocol as | |
| the Hedrocel and Trabecular Metal Monoblock Cups | |
| (K964509 and K003181). These acetabular devices are | |
| intended for use with Zimmer and Implex Components as | |
| described in K003181. |
1
510(k) Summary (Continued)
Indications for Use: The use of the Implex Hip System is indicated for: a) Severely disabled joints as a result of degenerative arthritis or avascular necrosis, b) Secondary revision of a previously unsuccessful femoral component or total hip replacement, c) Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results, d) Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be achieved, e) Non-union or femoral neck or head fractures, f) Salvage of a failed primary or secondary total or hemi hip. The Trabecular Metal Monoblock Acetabular Cup is Conclusion: substantially equivalent to the identified predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. 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
JUL 12 2002
Robert A. Poggie, Ph.D. Director, Applied Research Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K021970
Trade/Device Name: The Trabecular Metal Monoblock Acetabular Cup Regulation Number: 21 CFR 888.3358 and 888.3350 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis and Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: LPH and JDI Dated: June 14, 2002 Received: June 17, 2002
Dear Dr. Poggie:
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 (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.
3
Page 2 - Dr. Robert A. Poggie, Ph.D.
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 tollfree number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Stypt Ruode
Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known) :
021970
Device Name:
The Trabecular Metal Monoblock Acetabular Cup
Indications For Use:
The use of the Implex Hip System is indicated for:
- a) Severely disabled joints as a result of degenerative arthritis or avascular necrosis,
- b) Secondary revision of a previously unsuccessful femoral component or total hip replacement,
- c) Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results,
- d) Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be achieved,
- e) Non-union or femoral neck or head fractures,
- Salvage of a failed primary or secondary total or hemi hip. f)
(PLEASE 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
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| 510(k) Number | K021970 |
| Over-The-Counter Use |
(Optional Format 1-2-96)