(67 days)
Not Found
No
The summary describes a purely mechanical implant and associated surgical tools, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for use in total hip replacement procedures to alleviate severe pain and disability caused by various hip joint conditions, directly addressing a medical problem to improve patient health.
No
The device is an implantable component for hip replacement surgery, designed to reinforce the acetabular roof. It is a treatment device, not a diagnostic one.
No
The device description clearly states that the device is a physical component made of commercially pure titanium, intended for surgical implantation. It also describes associated physical instrumentation. This is not a software-only device.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The ULTIMA® Acetabular Roof Reinforcement Ring is a physical implant designed to be surgically placed within the hip joint to provide structural support during total hip replacement. It is a mechanical device used in vivo (within the body), not a test performed in vitro (outside the body).
The description clearly outlines its use as a surgical implant for reconstructing the acetabulum, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The ULTIMA® Acetabular Roof Reinforcement Ring is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.
The Ultima® Acetabular Roof Reinforcement Ring is secured in the prepared acetabulum using a combination of Polymethylmethacrylate (PMMA) bone cement, bone allograft, and cancellous screws to provide stabilization.
Product codes (comma separated list FDA assigned to the subject device)
87 IDI
Device Description
The ULTIMA® Acetabular Roof Reinforcement Ring is a support component for the reconstruction of the acetabulum and is composed of commercially pure titanium (cp Ti). The ULTIMA® Acetabular Roof Reinforcement Ring is a hemispherical shell with a mesh of screw holes covering the shell to allow for use with cancellous screws for additional stabilization.
The ULTIMA® Acetabular Roof Reinforcement Ring is used in conjunction with the ULTIMA® UHMWPE Acetabular Cup and Augmented UHMWPE Cup, and is held into the prepared acetabulum using a combination of Polymethylmethacrylate (PMMA) bone cement, bone allograft, and cancellous screws to provide primary stabilization.
The ULTIMA® Acetabular Roof Reinforcement Rings will be available in a range of designated sizes from 40mm through 62mm in 2mm increments. The nominal outer diameter of the ULTIMA® Acetabular Roof Reinforcement Ring is the same as the designated size.
The instrumentation used for implanting the ULTIMA® Acetabular Roof Reinforcement Ring includes a drill guide, 70mm drill, flexible shaft, depth gauge, tap and screw clamp, hemispherical reamers and a universal screw driver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, acetabulum
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): 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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/3 description: The image shows the text "K980286" in a handwritten style. Below this, the words "Exhibit I" are printed in a serif font. The text appears to be part of a document or label, possibly indicating an exhibit number or identification code.
APR 3 1998
510(k) Summary ULTIMA® Acetabular Roof Reinforcement Ring
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
1. Contact Person:
Janet G. Johnson Associate Regulatory Affairs Specialist (508) 828-3466
2. Device Information:
| Proprietary Name: | ULTIMA® Acetabular Roof Reinforcement
Ring |
|----------------------|------------------------------------------------------------------|
| Common Name: | Acetabular Roof Reinforcement Ring |
| Classification Name: | Hip joint metal/ polymer semi-constrained
cemented prosthesis |
| Regulatory Class: | Class II, per 21 §CFR 888.3350 |
| Product Code: | 87 IDI |
3. Indications for Use:
The ULTIMA® Acetabular Roof Reinforcement Ring is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.
The Ultima® Acetabular Roof Reinforcement Ring is secured in the prepared acetabulum using a combination of Polymethylmethacrylate (PMMA) bone cement, bone allograft, and cancellous screws to provide stabilization.
1
4. Device Description:
The ULTIMA® Acetabular Roof Reinforcement Ring is a support component for the reconstruction of the acetabulum and is composed of commercially pure titanium (cp Ti). The ULTIMA® Acetabular Roof Reinforcement Ring is a hemispherical shell with a mesh of screw holes covering the shell to allow for use with cancellous screws for additional stabilization.
The ULTIMA® Acetabular Roof Reinforcement Ring is used in conjunction with the ULTIMA® UHMWPE Acetabular Cup and Augmented UHMWPE Cup, and is held into the prepared acetabulum using a combination of Polymethylmethacrylate (PMMA) bone cement, bone allograft, and cancellous screws to provide primary stabilization.
The ULTIMA® Acetabular Roof Reinforcement Rings will be available in a range of designated sizes from 40mm through 62mm in 2mm increments. The nominal outer diameter of the ULTIMA® Acetabular Roof Reinforcement Ring is the same as the designated size.
The instrumentation used for implanting the ULTIMA® Acetabular Roof Reinforcement Ring includes a drill guide, 70mm drill, flexible shaft, depth gauge, tap and screw clamp, hemispherical reamers and a universal screw driver.
5. Substantial Equivalence:
The ULTIMA® Acetabular Roof Reinforcement Ring is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the Protek Roof Reinforcement Ring (K953578).
The determination of substantial equivalence for this device was based on a detailed device description and conformance with voluntary performance standards, e.g. ASTM F-67.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around an emblem. The emblem is a stylized depiction of an eagle with its wings spread, symbolizing protection and service.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1998 APR
Janet G. Johnson, RAC Associate Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive 02767-0350 Raynham, Massachusetts
Re: K980286 ULTIMA® Acetabular Roof Reinforcement Ring Trade Name: Regulatory Class: II Product Code: JDI Dated: January 23, 1998 Received: January 26, 1998
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 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 Requlations, Title 21, Parts 800 to 895. ಡಿ 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 regulatory In addition, FDA may publish further announcements action. 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.
3
Page 2 - Janet G. Johnson, RAC
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,
foiolesa
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
4
510(k) Number (if known) Device Name
K980286 ULTIMA® Acetabular Roof Reinforcement Ring
Indications For Use
The ULTMA® Acetabular Roof Reinforcement Ring is indicated for use in total 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, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.
The Ultima® Acetabular Roof Reinforcement Ring is secured in the prepared acetabulum using a combination of Polymethylmethacrylate (PMMA) bone cement, bone allograft, and cancellous screws to provide stabilization.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
bcooles
Prescription Use (Per 21 CFR §801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)