Not Found
No
The device description and intended use focus solely on the physical characteristics and clinical application of a hip prosthesis. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a hip prosthesis intended to replace a severely painful or disabled joint, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is a prosthesis, specifically a femoral hip prosthesis, intended for surgical implantation to replace a damaged hip joint. Its purpose is therapeutic, not diagnostic.
No
The device description clearly describes a physical implant made of Ti-6Al-4V, coated with hydroxyapatite, and details its physical characteristics and design. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant (a femoral hip prosthesis) for treating conditions affecting the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical characteristics and materials of a prosthetic implant, not a device used to analyze biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information for diagnosis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a physical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The KAR Hip Prosthesis is recommended for revision cases. It is intended for use as a press-fit femoral hip prosthesis where there is evidence that there is sufficient healthy cortical bone to seat the femoral component. This prosthesis is indicated for use in the following conditions: a severely painful and/or severely disabled joint resulting from osteoarthritis or rheumatoid arthritis , avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; or failed previous surgery including joint reconstruction, arthrodeses, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
Product codes
LZO, MEH
Device Description
The KAR Revision Hip is a non-cemented, long femoral stem made from Ti-6Al-4V, completely coated with hydroxyapatite. It has a straight stem with a quadrangular cross-section and blunt corners. The metaphyseal widening presents a bi-dimensional flare and horizontal and vertical grooves for metaphyseal support. The step-like structure of the grooves in the metaphyseal section provides stability. The distal section has symmetrical slopes. The diaphyseal section provides a distal anchor while the distal cross-slotted tip allows for elasticity in the stem and adaptability to the femoral curve. The stem has a 12/14 Morse-like taper.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Clinical studies indicate that the KAR femoral stem, a revision of the Corail femoral stem, has a comparable success rate to the Corail. Compared to the Osteonics Restoration Monolithic Hip Stem, the KAR had fewer post-operative complications and better Postel Merle D-Aubigne scores.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
K905298, K933567, K932935, R933108
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
| MANUFACTURER IDENTIFICATION: | JUL - 8 1997
Landanger-Landos
Z.I. La Vendue BP 88
52003 Chaumont FRANCE |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| SPONSOR IDENTIFICATION: | Cheryl Hastings
Manager, Clinical Affairs
DePuy Orthopaedics, Inc.
P.O. Box 988
Warsaw. IN 46581-0988 |
| ESTABLISHMENT REGISTRATION
NUMBER: | 1818910 |
| PROPRIETARY NAME: | KAR Revision Hip Prosthesis |
| PRODUCT CLASSIFICATION CODE: | 87 MEH |
| PROPOSED REGULATORY CLASS: | Class II |
| PREDICATE DEVICES: | Osteonics Restoration Monolithic Hip
Implex F-220 Press-Fit Femoral System
Landanger-Landos Corail Hip |
DESCRIPTION:
The KAR Revision Hip is a non-cemented, long femoral stem made from Ti-6Al-4V, completely coated with hydroxyapatite. It has a straight stem with a quadrangular cross-section and blunt corners. The metaphyseal widening presents a bi-dimensional flare and horizontal and vertical grooves for metaphyseal support. The step-like structure of the grooves in the metaphyseal section provides stability. The distal section has symmetrical slopes. The diaphyseal section provides a distal anchor while the distal cross-slotted tip allows for elasticity in the stem and adaptability to the femoral curve. The stem has a 12/14 Morse-like taper.
INDICATIONS AND INTENDED USE:
The KAR Hip Prosthesis is recommended for revision cases. It is intended for use as a press-fit femoral hip prosthesis where there is evidence that there is sufficient healthy cortical bone to seat the femoral component. This prosthesis is indicated for use in the following conditions: a severely painful and/or severely disabled joint resulting from osteoarthritis or rheumatoid arthritis , avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; or failed previous surgery including joint reconstruction, arthrodeses, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
SUMMARY OF CLINICAL DATA:
Clinical studies indicate that the KAR femoral stem, a revision of the Corail femoral stem, has a comparable success rate to the Corail. Compared to the Osteonics Restoration Monolithic Hip Stem, the KAR had fewer post-operative complications and better Postel Merle D-Aubigne scores.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl Hastings Manager, Clinical Affairs DePuv, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indianna 46581-0988
Re : K961732 KAR Hip Prosthesis Trade Name: Requlatory Class: II Product Codes: LZO and MEH Dated: June 5, 1997 Received: June 9, 1997
JUL - 8 1997
Dear Ms. Hastings:
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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitations:
- The package insert must reflect that the the KAR Hip 1. Prosthesis, made of Ti 6 Al-4V, with 5°12′30″ Morse taper trunnion only be used with the cobalt chrome femoral heads described within this submission, or Alumina femoral heads cleared under K905298, K933567, K932935, or R933108; and
- You may not label or in any way promote these devices ---2. for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or longterm stable fixation." The data presented support
2
Page 2 - Ms. Cheryl Hastings
equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only).
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.
The general controls provisions of the Act include requirements for annual reqistration, 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. ੱਡ
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of
3
Page 3 - Ms. Cheryl Hastings
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,
Cella 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)_K961732
Device Name KAR Revision Hip Prosthesis
Indications for Use:
This prosthesis is intended for use as a press-fit femoral hip prosthesis where there is evidence that there is I ma procented bone to seat the femoral component. This prosthesis is indicated for use in the following conditions: a severely painful and/or severely disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; or failed previous surgery including joint reconstruction, internal fixation, arthrodeses, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
Concurrence of CDRH, Office of Device Evaluation
Division of General Restorative
Prescription Use
X
(Per 21 CFR 801.109)