(69 days)
Not Found
No
The summary describes a traditional hip prosthesis with no mention of AI or ML capabilities.
Yes
The device is a hip prosthesis, which is used to replace damaged hip joints to increase mobility and reduce pain, falling under the definition of a therapeutic device.
No.
This device is a hip implant, specifically a "Total hip arthroplasty" system, intended to replace a damaged hip joint. Its purpose is therapeutic (providing mobility and reducing pain), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly states it is a "flanged, collared, tapered Cobalt-Chromium femoral stem," which 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a Summit™ Cemented Hip Prosthesis, which is a surgical implant used to replace a damaged hip joint. It is a physical device implanted into the body.
- Intended Use: The intended use clearly states that the device is for total hip arthroplasty to replace the damaged hip joint articulation. This is a surgical procedure, not an in vitro test.
The description focuses on the physical characteristics of the implant and its surgical application, not on analyzing biological samples.
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: 1. Severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis.
Product codes
87JDI
Device Description
The Summit™ Cemented Hip Prosthesis is a flanged, collared, tapered Cobalt-Chromium femoral stem with a smooth surface finish. There are 7 proportional body sizes with two offset options. Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 1 7 2001
510(k) Summary
335 d page 1 of 2
Name of Sponsor:
510(k) Contact:
Trade Name:
Common Name:
Classification:
Device Product Code:
Substantially Equivalent Device:
Device Descriptions:
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Est. Reg. No. 1818910
Marcia J. Arentz Senior Regulatory Associate Phone: (219) 371-4944 FAX: (219) 371-4987
Summit™ Cemented Hip Prosthesis
Total Hip Joint Replacement Prosthesis
Class II Device per 21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis
Code: 87JDI Prosthesis Hip Semi-constrained, Metal/Polymer, cemented No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems.
Endurance Total Hip System K942370 K900638 P.F.C. Hip System Vision AML Hip Prosthesis K953694
The Summit™ Cemented Hip Prosthesis is a flanged, collared, tapered Cobalt-Chromium femoral stem with a smooth surface finish. There are 7 proportional body sizes with two offset options. Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal.
1
510(k) Summary (continued)
| Intended 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. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use: | Total hip replacement is indicated in the following
conditions: |
| | 1. Severely painful and/or disabled joint from
osteoarthritis, traumatic arthritis, rheumatoid
arthritis, or congenital hip dysplasia. |
| | 2. Avascular necrosis of the femoral head. |
| | 3. Acute traumatic facture of the femoral head
or neck. |
| | 4. Failed previous hip surgery including joint
reconstruction, internal fixation, arthrodesis,
hemiarthroplasty, surface replacement
arthro-plasty, or total hip replacement. |
| | 5. Certain cases of ankylosis. |
| Substantial equivalence: | The Summit Cemented Hip Prosthesis has the same
intended use and basic design as the predicate
devices and is therefore substantially equivalent. |
00000000
2
Image /page/2/Picture/1 description: The image shows the 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 three overlapping lines that resemble an abstract human figure or a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 2001
Ms. Marcia J. Arentz Senior Regulatory Associate DePuy Orthopaedics, Incorporated 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988
K013352 Re:
Trade Name: Summit Cemented Hip Prosthesis Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI Dated: October 3, 2001 Received: October 9, 2001
Dear Ms. Arentz:
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.
3
Page 2 - Ms. Arentz
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,
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
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510(k) Number (if known): Ko | 335d
Page 1 of 1
Device Name: Summit™ Cemented Hip Prosthesis
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, 1. rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head or neck. 3.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. ડ.
Cemented Components:
Femoral stem and acetabular cup total hip components labcled "For cemented use only" are indicated only for use with bone cement.
This device is intended for single use.
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013352
OR
Concurrence of CDRH, Office of Device Evaluation
Prescription Use × (Per 21 CFR 801.109) Over-The-Counter Use
000003