(69 days)
Not Found
No
The summary describes a traditional hip implant system and its materials, intended use, and performance testing based on established orthopedic device guidance documents. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended to replace a hip joint in patients suffering from severe hip pain and disability due to various conditions, which directly addresses a health problem by restoring function and alleviating symptoms.
No
The device is an orthopedic implant (hip replacement system) used to treat severe hip conditions, not to identify or diagnose them.
No
The device description explicitly states the device is a femoral stem manufactured from titanium with coatings, which is a physical hardware component, 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 states that the Excia Hip System is intended to replace a hip joint. This is a surgical implant used directly in the body for treatment.
- Device Description: The description details a femoral stem, a component of a hip replacement system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a therapeutic implant.
N/A
Intended Use / Indications for Use
The Excia Hip System is intended to replace a hip joint.
The device is intended for:
- Patients suffering from severe hip and disability due to rheumatoid . arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped . capital femoral epiphysis
- Patients suffering from disability due previous fusion .
- . Patients with acute femoral neck fractures
The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without u-CaP®.
Product codes
LZO, LWJ, MEH, KWY
Device Description
The Excia M and ML femoral stem are available in one design. The femoral stem is manufactured from TI with a plasma spray coating (Plasmapore) with U-CaP®. The Excia M and ML femoral stem will be offered in an 8/10 or 12/14 taper. This component is intended for uncemented use.
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
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the;
- "Guidance Document for Testing Orthopedic Implants with Modified . Metallic Surfaces Apposing Bone or Bone Cement",
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed . Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements",
- "Guidance Document for Testing Non-articulating, "Mechanically Locked" . Modular Implant Components",
- "Draft Guidance Document for Testing Acetabular Cup Prostheses", .
- . "Points to Consider for Femoral Stem Prostheses",
- "Guidance Document for the Preparation of Premarket Notifications for . Ceramic Ball Hip Systems" and
- "Data Requirements for Ultrahigh Molecular Weight Poletheylene . (UHMWPE) Used in Orthopedic Devices" was completed where applicable.
Key Metrics
Not Found
Predicate Device(s)
K042344, K060437, K060918, K061344
Reference Device(s)
Not Found
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
Excia Total Hip System M and ML Femoral Stem
K092143
Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92) B.
SEP 2 2 2009
Excia Total Hip System M and ML Femoral Stem
July 13, 2009
Aesculap Implant Systems, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311
- CONTACT: Kathv A. Racosky 610-984-9291 (phone) 610-791-6882 (fax) kathy racosky@aesculap.com (email)
- TRADE NAME: Excia Total Hip System
- COMMON NAME: Femoral Hip Stem
- Hip ioint Metal/Ceramic/Polymer Semi-Constrained CLASSIFICATION NAME: Cemented or Non-Porous Uncemented Prosthesis
REGULATION NUMBER: 888.3353
PRODUCT CODE: LZO, LWJ, MEH, KWY
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, Inc. believes that Excia M and ML femoral stem is a line extension of Aesculap Implant Systems Excia (K042344, K060437, K060918, and K061344).
DEVICE DESCRIPTION
The Excia M and ML femoral stem are available in one design. The femoral stem is manufactured from TI with a plasma spray coating (Plasmapore) with U-CaP®. The Excia M and ML femoral stem will be offered in an 8/10 or 12/14 taper. This component is intended for uncemented use.
1
Page 2 of 2
INDICATIONS FOR USE
The Excia Hip System is intended to replace a hip joint.
The device is intended for:
- Patients suffering from severe hip and disability due to rheumatoid . arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped . capital femoral epiphysis
- Patients suffering from disability due previous fusion .
- . Patients with acute femoral neck fractures
The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without u-CaP®.
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))
The new Excia M and ML femoral stems of the Excia Total Hip System are offered in similar shapes and sizes as the predicate devices. The material used for the Aesculap Implant Systems device is the same as that used to manufacture the predicate devices.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the;
- "Guidance Document for Testing Orthopedic Implants with Modified . Metallic Surfaces Apposing Bone or Bone Cement",
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed . Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements",
- "Guidance Document for Testing Non-articulating, "Mechanically Locked" . Modular Implant Components",
- "Draft Guidance Document for Testing Acetabular Cup Prostheses", .
- . "Points to Consider for Femoral Stem Prostheses",
- "Guidance Document for the Preparation of Premarket Notifications for . Ceramic Ball Hip Systems" and
- "Data Requirements for Ultrahigh Molecular Weight Poletheylene . (UHMWPE) Used in Orthopedic Devices" was completed where applicable.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.
SEP 2 2 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Aesculap Implant Systems, Inc. % Ms. Kathy A. Racosky Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K092143
Trade/Device Name: Excia Total Hip System M and ML Femoral Stem Regulation Number: 21 CFR 888.3353
Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis
Regulatory Class: II Product Code: MEH, LZO, LWJ, KWY Dated: August 25, 2009
Received: August 26, 2009
Dear Ms. Racosky:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Kathy A. Racosky
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Oarlare buelup
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
K092143 510(k) Number:
Device Name: Excia Total Hip System M and ML Femoral Stem
Indications for Use:
The Excia Hip System is intended to replace a hip joint.
The device is intended for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral ● epiphysis
- Patients suffering from disability due previous fusion .
- Patients with acute femoral neck fractures .
The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without u-CaP®.
Sonata for mxn
(Division Signe (DWision Sign-Oir)
Division of Surgical, Orthopedic, Division of Survices
510(k) Number K092143
and/or Over-the-Counter Use × Prescription Use (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)