(22 days)
No
The summary describes a mechanical hip implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, a hip stem, is an implant used in total hip arthroplasty to replace a damaged hip joint, addressing severe pain and immobility. This aligns with the definition of a therapeutic device as it directly treats a medical condition to restore function and alleviate symptoms.
No
The device description indicates it is a "Total hip arthroplasty..." which is a replacement joint, not a tool for diagnosis. Its intended use is to "provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation".
No
The device description clearly describes a physical implant (femoral stem) made of Titanium, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical procedure to replace a damaged hip joint. This is a therapeutic intervention performed on the patient's body, not a test performed on a sample taken from the patient's body to diagnose a condition.
- Device Description: The device is a femoral stem, which is an implantable medical device used in surgery. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia;
- A vascular necrosis of the femoral head; ●
- Acute traumatic fracture of the femoral head or neck; ●
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, . hemiarthroplasty, surface replacement arthroplasty, or total hip replacement;
- . Certain cases of ankylosis.
Product codes
87 LZO, LWJ
Device Description
The Summit Basic Press-Fit Hip Stem is a collared, tapered Titanium femoral stem with a grit blasted finish. The Summit Basic Press-Fit Hip Stem is offered in 7 sizes with a constant neck offset. The stem is intended for cementless, press-fit fixation and is designed specifically to treat femoral head and neck fractures but can be used for any of the indications listed below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head, femoral neck
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
§ 888.3360 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
K030/22
page 171
2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Orthopaedics, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46581-0988 | FEB 05 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------|
| 510(k) CONTACT: | Cheryl Hastings
Director, Regulatory Affairs | |
| TRADE NAME: | DePuy Summit Basic Press-Fit Hip Prosthesis | |
| COMMON NAME: | Total Hip Joint Replacement Prosthesis | |
| CLASSIFICATION: | 888.3353: Hip joint metal/ceramic/polymer semi-
constrained cemented or non-porous uncemented
prosthesis; Class II | |
| DEVICE PRODUCT CODE: | 87 LZO | |
| SUBSTANTIALLY EQUIVALENT
DEVICE: | DePuy Response 2000 Hip Stems, K000392 | |
DEVICE DESCRIPTION:
The Summit Basic Press-Fit Hip Stem is a collared, tapered Titanium femoral stem with a grit blasted finish. The Summit Basic Press-Fit Hip Stem is offered in 7 sizes with a constant neck offset. The stem is intended for cementless, press-fit fixation and is designed specifically to treat femoral head and neck fractures but can be used for any of the indications listed below.
INTENDED USE AND INDICATIONS:
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia;
- A vascular necrosis of the femoral head; ●
- Acute traumatic fracture of the femoral head or neck; ●
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, . hemiarthroplasty, surface replacement arthroplasty, or total hip replacement;
- . Certain cases of ankylosis.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Summit Basic Press-Fit Hip Stem has the same basic design and has the same intended use as the Response 2000 Hip Stem. The Summit Basic Press-Fit Stem is manufactured from Ti-4V-6Al alloy while the Response 2000 Hip Stem is manufactured from Co-Cr-Mo alloy. The designs are similar - both stems are available in a single offset, but the Summit Basic Press-Fit Hip Stem is officred in only one stature while the Response 2000 Hip Stem is offered in large and small statures.
0000003
1
Image /page/1/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-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 5 2003
Ms. Cheryl Hastings Director, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K030122
Trade/Device Name: DePuy Summit Basic Press-Fit Hip Prosthesis Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-constrained Cemented Prosthesis Regulatory Class: Class II Product Code: LWJ Dated: January 13, 2003 Received: January 14, 2003
Dear Ms. Hastings:
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
2
Page 2 -- Ms. Cheryl Hastings
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. 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), 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark N. Milken
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known) _ Kos of レレレ
Device Name DePuy Summit Basic Press-Fit Hip Stem
Intended Use and Indications:
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid . arthritis, or congenital hip dysplasia;
- Avascular necrosis of the femoral head; .
- Acute traumatic fracture of the femoral head or neck; .
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, . hemiarthroplasty, surface replacement arthroplasty, or total hip replacement;
- Certain cases of ankylosis. .
Concurrence of CDRH, Office of Device Evaluation
for
| (Division Sign-Off) | |
|---|---|
| Division of | Geriatric, Restorative |
| and Neurological Devices | |
| 510(k) Number | K030122 |
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The Counter Use$\mathcal{B}$