(80 days)
Not Found
No
The description focuses on the material, design, and mechanical properties of a hip stem, with no mention of AI or ML capabilities.
Yes
The device is a hip stem used in total hip replacement procedures to alleviate severe pain and disability, which aligns with the definition of a therapeutic device.
No
The text describes a surgical implant (Total Hip Stem) used in hip replacement procedures, not a device designed for diagnosis. Its intended use is to treat existing conditions rather than identify them.
No
The device description clearly states it is a "one-piece porous coated hip stem that manufactured from titanium alloy (Ti-6Al-4V)", indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The UNI-ROM™ Total Hip Stem is a surgical implant designed to replace a damaged hip joint. It is a physical device inserted into the body during surgery.
- Intended Use: The intended use clearly states it's for "total hip replacement procedures" to address structural damage in the hip joint. This is a surgical intervention, not a diagnostic test performed on a specimen.
The information provided describes a medical device used in vivo (within the body) for treatment, not a device used in vitro (in a lab) for diagnosis.
N/A
Intended Use / Indications for Use
The UNI-ROM™ Total Hip Stem 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.
Product codes
87 LPH
Device Description
The UNI-ROM™ Femoral Hip Stem is a one-piece porous coated hip stem that manufactured from titanium alloy (Ti-6Al-4V). The stem is designed with steps on the outer surface of the porous-coated area to encourage compressive loading of the bone there by allowing for uncemented fixation. The proximal circumferential area is porous coated with commercially pure titanium. The UNI-ROM™ Femoral Hip Stem is anatomically shaped with flutes and a coronal slot in the distal portion of the stem.
The UNI-ROM™ Femoral hip stem can be used in either the right or left hip and mates with the femoral hip head using an 11/13 Morse-type taper. Further, the femoral stem is designed to accept an S-ROM Co-Cr Femoral head or an S-ROM Ceramic Femoral Head.
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
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)
The determination of substantial equivalence for this device was based in part on bench top performance data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
S-ROM Femoral Hip Stem (K961939, K954935 and K851422), P.F.C. 2 Femoral Stem (K945518 and K935452)
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
Exhibit I
510(k) Summary UNI-ROM™ Femoral Hip Stem
FEB - 6 1998 1974351
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
1. Contact Person:
Janet G. Johnson Associate Regulatory Affairs Specialist (508) 828-3466
Device Information: 2.
| Proprietary Name: | UNI-ROM™ Total Hip System Femoral
Stem |
|----------------------|-------------------------------------------------------------------------------------------|
| Common Name: | Femoral Stem Prostheses |
| Classification Name: | Hip joint metal/polymer/metal semi-
constrained porous-coated uncemented
prosthesis |
| Regulatory Class: | Class II, per 21 §CFR 888.3358 |
| Product Code: | 87 LPH |
3. Substantial Equivalence:
The UNI-ROM™ Femoral Hip Stem is substantially equivalent in terms of intended use, materials, design, manufacturing processes, sterilization method, packaging and performance to the S-ROM Femoral Hip Stem (K961939, K954935 and K851422) and P.F.C. 2 Femoral Stem (K945518 and K935452).
4. Indications for Use:
The UNI-ROM™ Total Hip Stem 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.
1
5. Physical Description:
The UNI-ROM™ Femoral Hip Stem is a one-piece porous coated hip stem that manufactured from titanium alloy (Ti-6Al-4V). The stem is designed with steps on the outer surface of the porous-coated area to encourage compressive loading of the bone there by allowing for uncemented fixation. The proximal circumferential area is porous coated with commercially pure titanium. The UNI-ROM™ Femoral Hip Stem is anatomically shaped with flutes and a coronal slot in the distal portion of the stem.
The UNI-ROM™ Femoral hip stem can be used in either the right or left hip and mates with the femoral hip head using an 11/13 Morse-type taper. Further, the femoral stem is designed to accept an S-ROM Co-Cr Femoral head or an S-ROM Ceramic Femoral Head.
The determination of substantial equivalence for this device was based in part on bench top performance data.
2
Similarities and Differences Matrix
| | UNI-ROM™
Femoral Hip
Stem | S-ROM®
Femoral Hip
Stem (K961939,
K954935 and
K851422) | P.F.C. 2 Femoral
Stem - Size
Small (K945518
and K935452) |
|------------------------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------|
| DESIGN | | | |
| Femoral Head
locks onto the stem
with a Morse-type
taper lock | Yes | Yes | Yes |
| Intended for non-
cemented fixation | Yes | Yes | Yes |
| Distal Slot | Yes | Yes | No |
| Distal Flutes | Yes | Yes | Yes |
| Adjunct to a Total
Hip System | Yes | Yes | Yes |
| Anatomically
Shaped | Yes | Yes | Yes |
| Press Fit | Yes | Yes | Yes |
| Porous Coating | Proximal | Proximal Sleeve | Proximal |
| Recommended for
use with: | Femoral Heads
with a 11/13
Morse Type
Taper | Femoral Heads
with a 11/13
Morse Type
Taper | Femoral Heads
with a 10/12
Morse Type
Taper |
| INTENDED | | | |
| Indicated for use in
primary hip
replacement
procedures. | Yes | Yes | Yes |
| MATERIALS | | | |
| Ti-6Al-4V Substrate | Yes | Yes | Yes |
| Commercially Pure
Titanium Porous
Coating | Yes | Yes | No |
| Ti-6Al-4V Porous
Coating | No | No | Yes |
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 6 1998
Ms. Janet G. Johnson · Associate Regulatory Affairs Specialist Johnson and Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K974331 UNI-ROM™ Femoral Hip Stem Trade Name: Regulatory Class: II Product Code: LPH Dated: November 17, 1997 Received: November 18, 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 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 regulation may result in regulatory 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 regulations.
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 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.
Celta 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
510(k) Number (if known) Device Name
UNI-ROM™ Femoral Hip Stem
~ Indications For Use:
The UNI-ROM™ Total Hip System Femoral Stem 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.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General Restorative Devices K974331 510(k) Number .
Prescription Use X (Per 21 CFR §801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)