(85 days)
No
The description focuses on the material, shape, and intended use of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a femoral hip stem intended for use in total hip replacement surgery to address conditions like osteoarthritis and traumatic fractures, aiming to restore function and alleviate pain.
No
Explanation: The device is a femoral hip stem intended for total hip replacement surgery, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states the device is manufactured from Ti-6Al-4V and is an anatomically shaped femoral hip stem, 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 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 provided text clearly describes a femoral hip stem, which is an implantable device used in surgery to replace the femoral component of a hip joint. It is a physical prosthesis inserted into the body.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is purely structural and functional within the body.
Therefore, based on the provided information, the S-ROM Femoral Hip Stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The S-ROM Femoral Hip Stem - Sizes 12 x 06 x 115 and 12 x 07 x 115 is intended for non-cemented fixation as the femoral component of a total hip replacement system. The stems are indicated for use in primary and revision replacement surgery. The prosthesis may be used for the following conditions, as appropriate:
- Osteoarthritis; .
- . Traumatic Fractures;
- . Rheumatoid Arthritis;
- Avascular Necrosis; and .
- Congenital Dislocation. .
Product codes
Not Found
Device Description
The S-ROM Femoral Hip Stems (Sizes 12 x 06 x 115 and 12 x 07 x 115) are manufactured from Ti-6Al-4V, the same material used to manufacture the S-ROM femoral hip stems in the larger sizes and that has been used in orthopaedic implants for many years with established clinical success. The S-ROM Femoral Hip Stems are anatomically shaped with flutes and a coronal slot in the distal portion of the stem. The size 12 x 06 x 115 and 12 x 07 x 115 stems, as well as the larger size S-ROM femoral hip stems, can be used in either the right or left hip.
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
Testing was conducted per the FDA's Draft Guidance Document for Femoral Stem Prostheses, in accordance with ISO 7206-4.
Key Metrics
Not Found
Predicate Device(s)
K851422, K913231, K921111, K934412, K910664, K954935
Reference Device(s)
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
K9619399
AUG 13 1996
Anpendix I
510(k) Summary of Safety and Effectiveness
S-ROM® Total Hip System
S-ROM® Femoral Hip Stem - Sizes 12 x 06 x 115 and 12 x 07 x115
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767 USA ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Contact Person
J. Teresa Dorriety, Esq. Sr. Regulatory Affairs Specialist Phone: (508) 880-8404 Fax: (508) 828-3212
Name of Device________________________________________________________________________________________________________________________________________________________________
| Proprietary Name: | S-ROM® Femoral Hip Stem - Sizes 12 x 06 x 115 and 12 x 07 x 115 |
|---|---|
| Common Name: | Femoral Hip Stem |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis |
Device Classification
This device has been placed in Class II for Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis per 21 CFR §888.3358.
:
Statement of Substantial Equivalence__________________________________________________________________________________________________________________________________________
The S-ROM Femoral Hip Stems (Sizes 12 x 06 x 115 and 12 x 07 x 115) are substantially equivalent to several hip prostheses currently marketed in the United States for hip replacement including the S-ROM Femoral Hip Stems cleared under #K851422, #K913231, #K921111, #K934412, #K910664 and #K954935. The subject device is also substantially equivalent to hip prostheses such as the P.F.C.® Total Hip System (#K944518).
1
The subject device is composed of the same materials as similar stems marketed in the United States. Further, the intended use, design, and manufacture of the S-ROM femoral hip stems 12 x 06 x 115 and 12 x 07 x 115 are substantially equivalent to currently distributed hip stems. Additionally, the packaging and method of sterilization are currently utilized for other S-ROM stems, as well as other stems currently distributed in the United States.
Indications for Use___________________________________________________________________________________________________________________________________________________________
The S-ROM Femoral Hip Stem - Sizes 12 x 06 x 115 and 12 x 07 x 115 is intended for non-cemented fixation as the femoral component of a total hip replacement system. The stems are indicated for use in primary and revision replacement surgery. The prosthesis may be used for the following conditions, as appropriate:
- Osteoarthritis; .
- . Traumatic Fractures;
- . Rheumatoid Arthritis;
- Avascular Necrosis; and .
- Congenital Dislocation. .
Physical Description ---------------------------------------------------------------------------------------------------------------------------------------------------------
The S-ROM Femoral Hip Stems (Sizes 12 x 06 x 115 and 12 x 07 x 115) are manufactured from Ti-6Al-4V, the same material used to manufacture the S-ROM femoral hip stems in the larger sizes and that has been used in orthopaedic implants for many years with established clinical success. The S-ROM Femoral Hip Stems are anatomically shaped with flutes and a coronal slot in the distal portion of the stem. The size 12 x 06 x 115 and 12 x 07 x 115 stems, as well as the larger size S-ROM femoral hip stems, can be used in either the right or left hip.
Testing was conducted per the FDA's Draft Guidance Document for Femoral Stem Prostheses, in accordance with ISO 7206-4.