(431 days)
This prosthesis 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, 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.
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.
Here's an analysis of the provided text regarding the KAR Revision Hip Prosthesis, focusing on acceptance criteria and the supporting study:
The provided documents describe a 510(k) submission for the KAR Revision Hip Prosthesis. A 510(k) submission typically aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through extensive clinical trials with predefined acceptance criteria. Therefore, the information provided is structured around this regulatory pathway.
1. Table of Acceptance Criteria and Reported Device Performance
It's important to clarify that for a 510(k) submission, "acceptance criteria" for performance are usually framed as demonstrating comparable performance to a predicate device, rather than meeting specific numerical thresholds for a novel device. The "study" isn't a prospective pivotal clinical trial with a primary endpoint and corresponding statistical hypothesis and power calculation, but rather a comparison study.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Comparable Success Rate (to predicate Corail femoral stem) | "Clinical studies indicate that the KAR femoral stem, a revision of the Corail femoral stem, has a comparable success rate to the Corail." |
| Fewer Post-operative Complications (compared to Osteonics Restoration Monolithic Hip Stem) | "Compared to the Osteonics Restoration Monolithic Hip Stem, the KAR had fewer post-operative complications..." |
| Better Postel Merle D-Aubigne Scores (compared to Osteonics Restoration Monolithic Hip Stem) | "...and better Postel Merle D-Aubigne scores." |
| Mechanical Interlock Performance (no additional claims beyond conventional press-fit) | "The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only)." (This is a condition for clearance, not a direct performance metric, but implies the mechanical properties must be at least equivalent to predicate press-fit devices.) |
2. Sample Size Used for the Test Set and Data Provenance
The documents do not specify the exact sample size for the clinical studies. They generally refer to "Clinical studies."
The data provenance is not explicitly stated in terms of country of origin. However, given the manufacturer (Landanger-Landos, France) and sponsor (DePuy Orthopaedics, Inc., USA), it's possible the data could be from studies conducted in either or both regions, or other international locations.
The studies appear to be retrospective or a combination of retrospective and prospective observational studies, as there's no mention of a pre-planned, controlled clinical trial. The phrasing "Clinical studies indicate" suggests a review of existing clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The documents do not provide information on the number of experts, their qualifications, or how ground truth was established for the clinical data used in this 510(k) submission. This is not typically required to be detailed in this type of regulatory filing, as the focus is on substantial equivalence based on existing clinical outcomes data rather than de novo validation of a diagnostic algorithm.
4. Adjudication Method for the Test Set
The documents do not provide information on any adjudication method used for the clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images, not for orthopedic implants. The study described compares the performance of the implant itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical orthopedic implant (a hip prosthesis), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" here refers to the actual clinical outcomes of patients who received the hip prosthesis. This includes:
- Success Rate: Implies positive patient outcomes, likely measured through various clinical assessments over time.
- Post-operative Complications: Objective reporting of adverse events.
- Postel Merle D-Aubigne scores: A clinical scoring system used to assess hip function (pain, walking, mobility).
The ground truth is essentially clinical outcomes data from patients.
8. The Sample Size for the Training Set
This question is not applicable. The KAR Revision Hip Prosthesis is a physical device, not an AI or algorithm that requires a "training set." The phrase "training set" refers to data used to train machine learning models.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
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SUMMARY OF SAFETY AND EFFECTIVENESS
| MANUFACTURER IDENTIFICATION: | JUL - 8 1997Landanger-LandosZ.I. La Vendue BP 8852003 Chaumont FRANCE |
|---|---|
| SPONSOR IDENTIFICATION: | Cheryl HastingsManager, Clinical AffairsDePuy Orthopaedics, Inc.P.O. Box 988Warsaw. IN 46581-0988 |
| ESTABLISHMENT REGISTRATIONNUMBER: | 1818910 |
| PROPRIETARY NAME: | KAR Revision Hip Prosthesis |
| PRODUCT CLASSIFICATION CODE: | 87 MEH |
| PROPOSED REGULATORY CLASS: | Class II |
| PREDICATE DEVICES: | Osteonics Restoration Monolithic HipImplex F-220 Press-Fit Femoral SystemLandanger-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.
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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
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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
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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
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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)
Over-The Counter Use__________________________________________________________________________________________________________________________________________________________
§ 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.