(209 days)
Not Found
No
The device description focuses on the material, design, and mechanical properties of a hip stem, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a hip stem used in total or partial hip replacement procedures to alleviate pain and disability caused by various hip joint conditions. This directly addresses medical conditions to improve health, which is the definition of a therapeutic device.
No
The device description clearly states it is a "Cemented Stem" used in hip replacement procedures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical hip stem forged from Cobalt-Chromium alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ULTIMA* TPS Cemented Stem is a physical implant designed to be surgically placed within the human body (specifically, the hip joint). It is a prosthetic device, not a test or assay performed on a sample outside the body.
- Intended Use: The intended use clearly describes its function as a component in total or partial hip replacement procedures to address structural damage and disability. This is a surgical intervention, not a diagnostic test.
Therefore, the ULTIMA* TPS Cemented Stem falls under the category of a medical device (specifically, a prosthetic implant), but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ULTIMA* TPS Cemented Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to:
- structural damage in the hip joint from rheumatoid arthritis,
- osteoarthritis,
- post-traumatic arthritis,
- collagen disorders,
- avascular necrosis,
- nonunion of femoral fractures,
- congenital hip dysplasia,
- protrusio acetabuli,
- slipped capital femoral epiphysis, and
- disability due to previous fusion where bone stock is inadequate for other reconstruction techniques.
The ULTIMA* TPS Cemented stem is indicated for use only with PMMA bone cement.
Product codes (comma separated list FDA assigned to the subject device)
87JDI, KWL
Device Description
The ULTIMA* TPS Cemented Stem is forged from a Cobalt-Chromium alloy which conforms to ASTM F799; this material has high strength and good hardness properties and is also highly immune to fatigue. The ULTIMA* TPS Cemented Stem is polished to a bright finish on all surfaces below the spigot and can be used interchangeably in either the left or the right hip. The stem is straight, tapering towards the distal tip in both the mediolateral and anteriorposterior sections. It does not have a proximal collar.
The ULTIMA* TPS Cemented Stem has a 10/12 Morse taper; it will be available in six sizes (0, 1 - 5), each of the 1 - 5 sizes have a choice of either a 37.5 mm (standard) offset, or a 44.0 mm (medialized "M") offset. In addition to this central range, there shall be two long stern options. The stem can be used with various neck heads (22.225, 26, 28 and 32 mm) as well as neck options (-5 (32), -3 (28), 0, +5 and +10). All of the stems in the range have a neck angle of 125°.
The distal centralizer that is used with the ULTIMA* TPS stem comes in a range of sizes and is manufactured from PMMA. There are three wings on the centralizer which ensure the orientation of the stem distally. These increase in size through the centralizer range to deal with the variation in anatomy of the medullary canal. In revision surgery, a "wingless" centralizer is required, thus a 7mm diameter version is available which simply acts to provide the void, and does not centralize the stem.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Testing results demonstrate that the ULTIMA* TPS Cemented Stem is substantially equivalent by withstanding a maximum load of 2,300N force, 5,000,000 cycles, and, as such meets the set criteria for the establishment of "substantial equivalence".
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.
K891454, Zimmer CPT hip stem
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
§ 888.3360 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
K965198
Summary of Safety & Effectiveness Data JUL 2 3 1997 for the ULTIMA* TPS Cemented Stem
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
1. Contact Person
Janet G. Johnson, Assoc. Regulatory Affairs Specialist, (508) 828-3466.
2. Device Name
| Proprietary Name: | ULTIMA* TPS Cemented Stem |
|---|---|
| Common Name: | Hip joint metal/polymer semi-constrained cemented prosthesis |
| Classification Name: | Prosthesis, Hip |
| Regulatory Class: | Class II by 21 CFR § 888.3350 |
| Product Code: | 87JDI |
| Owner/ Operator # | 9001269 |
3. Device Classification
Classification for ULTIMA* TPS Cemented Stem has been placed in Class II by 21 CFR & 888.3350
4. Statement of Substantial Equivalence
The safety and effectiveness of the ULTIMA* TPS Cemented Stem is substantially equivalent in terms of function to the Howmedica Exeter hip stem (#K891454) and to the Zimmer CPT hip stem. Furthermore, testing results demonstrate that the ULTIMA* TPS Cemented Stem is substantially equivalent by withstanding a maximum load of 2,300N force, 5,000,000 cycles, and, as such meets the set criteria for the establishment of "substantial equivalence".
1
ર. Indications for Use
The ULTIMA* TPS Cemented Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to:
-
- structural damage in the hip joint from rheumatoid arthritis,
-
- osteoarthritis,
-
- post-traumatic arthritis,
-
- collagen disorders,
-
- avascular necrosis,
-
- nonunion of femoral fractures,
-
- congenital hip dysplasia,
-
- protrusio acetabuli,
-
- slipped capital femoral epiphysis, and
-
- disability due to previous fusion where bone stock is inadequate for other reconstruction techniques.
The ULTIMA* TPS Cemented stem is indicated for use only with PMMA bone cement.
6. Physical Description
The ULTIMA* TPS Cemented Stem is forged from a Cobalt-Chromium alloy which conforms to ASTM F799 (EXHIBIT IV); this material has high strength and good hardness properties and is also highly immune to fatigue. The ULTIMA* TPS Cemented Stem is polished to a bright finish on all surfaces below the spigot and can be used interchangeably in either the left or the right hip. The stem is straight, tapering towards the distal tip in both the mediolateral and anteriorposterior sections. It does not have a proximal collar.
The ULTIMA* TPS Cemented Stem has a 10/12 Morse taper; it will be available in six sizes (0, 1 - 5), each of the 1 - 5 sizes have a choice of either a 37.5 mm (standard) offset, or a 44.0 mm (medialized "M") offset. In addition to this central range, there shall be two long stern options. The stem can be used with various neck heads (22.225, 26, 28 and 32 mm) as well as neck options (-5 (32), -3 (28), 0, +5 and +10). All of the stems in the range have a neck angle of 125°.
| Stem Size | Trunnion
Designs | Offset | Neck
Heads | Neck
Options | Neck
Angle |
|-------------|---------------------|------------------|-----------------------------|---------------------------------------|---------------|
| 0,1,2,3,4,5 | 10/12 taper | 37.5 /
44.0mm | 22.225,
26, 28, 32
mm | -5 (32),
-3 (28),
0, +5,
+10 | 125° |
2
Distal The distal centralizer that is used with the ULTIMA* TPS stem Centralizer comes in a range of sizes and is manufactured from PMMA. There are three wings on the centralizer which ensure the orientation of the stem distally. These increase in size through the centralizer range to deal with the variation in anatomy of the medullary canal. In revision surgery, a "wingless" centralizer is required, thus a 7mm diameter version is available which simply acts to provide the void, and does not centralize the stem.
| | ULTIMA* TPS
Cemented Stem | Howmedica
Exeter hip stem | Zimmer CPT hip
stem |
|--------------------------------------|------------------------------|------------------------------|------------------------|
| DESIGN | | | |
| Polished | Yes | Yes | Yes |
| Collarless | Yes | Yes | Yes |
| Double-taper
geometry | Yes | Yes | Yes |
| | | | |
| INTENDED USE | | | |
| Total / partial hip
replacement | Yes | Yes | Yes |
| Used with distal
centralizer | Yes | Yes | Yes |
| | | | |
| MATERIALS | | | |
| Orthinox™ (stainless
steel alloy) | No | Yes | No |
| Zimtron™ (stainless
steel alloy) | No | No | Yes |
| Cobalt-Chromium-
Molybdenum | Yes | No | No |
Table 1. Similarities and Differences Matrix
3
Image /page/3/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 eagle with three wing segments, symbolizing service to the nation. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Janet G. Johnson Associate Regulatory Affairs Specialist Johnson & Johnson Professional, Iñc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
JUL 2 3 1997
Re: K965198 Ultima* TPS Cemented Stem Regulatory Class: II Product Codes: JDI and KWL Dated: April 22, 1997 Received: April 25, 1997
Dear Ms. Johnson:
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 Requlations, 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. I 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 requlations.
4
Page 2 - Ms. Janet G. Johnson
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 leqally 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.qov/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
Indications for Use for the ULTIMA* TPS Cemented Stem
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Indications for Use K965198
The ULTIMA* TPS Cemented Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to:
- structural damage in the hip joint from rheumatoid arthritis, 1.
-
- osteoarthritis,
- post-traumatic arthritis, 3.
-
- collagen disorders,
- ડ. avascular necrosis,
- Q. nonunion of femoral fractures,
-
- congenital hip dysplasia.
-
- protrusio acetabuli,
-
- slipped capital femoral epiphysis, and
-
- disability due to previous fusion where bone stock is inadequate for other reconstruction techniques.
The ULTIMA* TPS Cemented Stem is indicated for use only with PMMA bone cement.
Prescription Use
(Per 21 CFR 801.109)
Director Sign Off