(60 days)
Not Found
No
The summary describes a mechanical implant for hip replacement and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is an acetabular system used in total hip replacement procedures to alleviate severe pain and disability caused by various hip joint conditions, which aligns with the definition of a therapeutic device.
No.
The device is an acetabular system used in total hip replacement procedures, which is a therapeutic intervention, not a diagnostic tool.
No
The device description clearly states the device is composed of physical components made of titanium alloy and UHMWPE, which are hardware materials, not software.
Based on the provided text, the SUMMIT™ Acetabular System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for total hip replacement procedures to treat structural damage in the hip joint. This is a surgical intervention on the human body, not a test performed on samples taken from the body.
- Device Description: The device is a physical implant (acetabular shell and liner) designed to be surgically placed in the hip joint. IVD devices are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
Therefore, the SUMMIT™ Acetabular System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SUMMIT™ Acetabular System 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, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and 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 reconstruction techniques.
All SUMMIT™ porous -coated acetabular shells are indicated for cementless application.
Product codes
87 LPH
Device Description
The SUMMIT™ Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, an outer shell composed of titanium alloy (Ti-6Al-4V) with a commercially pure titanium porous coating and a liner of ultrahigh molecular weight polyethylene (UHMWPE), which locks into the outer shell. The acetabular component articulates with a femoral head of an appropriate diameter.
The acetabular shell has a porous-coated surface and is provided No-Hole, Cluster Hole, Multi-Hole, Spiked and Deep Profile configurations that accept liners for 22.225, 26, 28 and 32mm femoral head sizes; as well as 0°, 10°, and 15° face angles.
Also available for use with the SUMMIT™ Acetabular System are an apical hole plug and a variety of bone screws, all composed of titanium alloy.
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 on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ASTM F-67, ASTM F136 and ASTM F1044.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K951000, K955511, K931189, K930712, K951301
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 SUMMIT™ Acetabular System
K98 3014
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
A. Contact Person:
Janet G. Johnson, RAC Associate Regulatory Affairs Specialist (508) 828-3466
B. Device Information:
| Proprietary Name: | SUMMIT™ Acetabular System |
|---|---|
| Common Name: | Acetabular Cup and Liner |
| Classification Name: | Hip joint metal/ polymer semi-constrained porous- |
| coated uncemented prosthesis | |
| Regulatory Class: | Class II, per 21 §CFR 888.3358 |
| Product Code: | 87 LPH |
C. Indications for Use:
The SUMMIT™ Acetabular System 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, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and 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 reconstruction techniques.
All SUMMIT™ porous -coated acetabular shells are indicated for cementless application.
1
D. Device Description:
The SUMMIT™ Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, an outer shell composed of titanium alloy (Ti-6Al-4V) with a commercially pure titanium porous coating and a liner of ultrahigh molecular weight polyethylene (UHMWPE), which locks into the outer shell. The acetabular component articulates with a femoral head of an appropriate diameter.
The acetabular shell has a porous-coated surface and is provided No-Hole, Cluster Hole, Multi-Hole, Spiked and Deep Profile configurations that accept liners for 22.225, 26, 28 and 32mm femoral head sizes; as well as 0°, 10°, and 15° face angles.
Also available for use with the SUMMIT™ Acetabular System are an apical hole plug and a variety of bone screws, all composed of titanium alloy.
E. Substantial Equivalence:
The SUMMIT™ Acetabular System is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the ZTT™ I and II Acetabular Cup (K951000), Arthopor™ I and II (K955511), PFC ™ Acetabular Cup (K931189 and K930712) and the DePuy DURALOC ® 300 Series (K951301).
The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ASTM F-67, ASTM F136 and ASTM F1044.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 1998
Janet G. Johnson, RAC Associate Requlatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K983014 Summit™ Acetabular System Trade Name: Regulatory Class: II Product Code: LPH Dated: August 27, 1998 Received: August 28, 1998
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, Druq, 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. ਸੋ 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.
3
Paqe 2 - Janet G. Johnson, RAC
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 requlation (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., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known) Device Name
SUMMIT™ Acetabular System
Indications For Use
The SUMMIT™ Acetabular System 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, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and 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 reconstruction techniques.
All SUMMIT™ porous -coated acetabular shells are indicated for cementless application.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | Yes |
|---|---|
| (Per 21 CFR §801.109) |
OR
| Over-the-Counter Use | No |
|---|---|
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K983014 |
|---|---|
| --------------- | --------- |