(29 days)
Not Found
No
The summary describes a mechanical implant (femoral stem) and its intended use, with no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
Yes
The device is a hip stem intended for total hip arthroplasty, which is a surgical procedure to replace a damaged hip joint and reduce pain, clearly indicating a therapeutic purpose.
No
This device is a surgical implant (femoral stem for hip replacement), not a diagnostic tool. Its purpose is to replace damaged anatomical structures to improve mobility and reduce pain, not to identify or characterize a disease or condition.
No
The device description clearly describes a physical implant (femoral stem) made of Cobalt-Chromium, which is a hardware component. The summary does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace a damaged hip joint through surgery (total hip arthroplasty). This is a surgical implant, not a test performed on biological samples outside the body.
- Device Description: The device is a physical implant (femoral stem) made of Cobalt-Chromium.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
The device is clearly a surgical implant used in vivo (within the living body) to restore function to a damaged joint.
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 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, rheumatoid 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.
The Summit FX Cemented Hip Stem is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JDI
Device Description
The Summit FX Cemented Hip Stem is a flanged, collared, tapered Cobalt-Chromium femoral stem with a smooth surface finish. The Summit FX Cemented Hip Stem is offered in 7 sizes with a constant offset. A distal PMMA centralizer helps assure that the stem is centered in the femoral canal. The stem 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): 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
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, IN 46581-0988 |
|---|---|
| 510(k) CONTACT: | Cheryl Hastings Director, Regulatory Affairs |
| TRADE NAME: | DePuy Summit FX Cemented Hip Prosthesis |
| COMMON NAME: | Total Hip Joint Replacement Prosthesis |
| CLASSIFICATION: | 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis; Class II |
| DEVICE PRODUCT CODE: | 87 JDI |
| SUBSTANTIALLY EQUIVALENT DEVICE: | DePuy Summit Cemented Hip Prosthesis, K013352 |
page 1
DEVICE DESCRIPTION:
The Summit FX Cemented Hip Stem is a flanged, collared, tapered Cobalt-Chromium femoral stem with a smooth surface finish. The Summit FX Cemented Hip Stem is offered in 7 sizes with a constant offset. A distal PMMA centralizer helps assure that the stem is centered in the femoral canal. The stem 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 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, rheumatoid ● 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. ●
The Summit FX Cemented Hip Stem is intended for cemented use only.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Summit FX Cemented Hip Stem is manufactured from the same material and has the same intended use as the Summit Cemented Hip Stem. The designs are similar, but the Summit FX Cemented Hip Stem is offered in only one offset and has no proximal centralizer beads. The Summit Cemented Hip Stem is offered in two offsets and includes proximal centralizer beads.
0000003
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl Hastings Director. Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 4681-0988
Re: K023453
Trade Name: Summit FX Cemented Hip Stems Regulation Number: 21 CRF 888.3350 Regulation Name: Hip Joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI Dated: October 11, 2002 Received: October 15, 2002
Dear Ms. Hastings:
We have reviewed your Section 510(k) premarket 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) 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 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.
2
Page 2 - Ms. Cheryl Hastings
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 and additionally 21 CFR Part 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" (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 A. Milluzzo
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
- 34.5 510(k) Number (if known)
page 10 of 1
Device Name DePuy Summit FX Cemented 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 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;
- 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.
The Summit FX Cemented Hip Stem is intended for cemented use only.
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Concurrence of CDRH, Office of Device Evaluation
Mark N. Milken
(Division Sign-Off) Division of General, Restorative and Neurological Devices 023453
510(k) Number -
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use
0000004