(75 days)
Not Found
No
The document describes a traditional hip replacement system and its components, focusing on materials, intended use, and performance testing against established orthopedic device standards. 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 to alleviate pain and disability caused by various severe hip conditions, which is a therapeutic purpose.
No
The Excia Hip System is described as a device intended to replace a hip joint in patients with various hip conditions. This is a therapeutic device, not a diagnostic one. Its purpose is to treat a condition, not to identify or diagnose it.
No
The device description and performance studies clearly indicate this is a physical orthopedic implant (hip system components made of CoCrMo, Ti, and ceramic) and not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "replace a hip joint" in patients with various hip conditions. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (hip system components like femoral stems and a ceramic head).
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
The Excia Hip System is a medical device used in vivo (within the living body) for surgical implantation, not a diagnostic test performed in vitro (outside the living body).
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 pain and disability due to rheumatoid . arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necosis 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 to 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 p CaP®.
Product codes
LZO, MEH, LWJ, JDI
Device Description
The Excia 36mm Ceramic Head is manufactured from ceramic (Al2O3) and conforms to ISO 6474. The 36mm diameter head is offered in three different head lengths (-3.5 mm, 0 mm, and +3.5mm). These ceramic heads allow the surgeon further option to meet the patient's needs.
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Excia Total Hip System 36mm Ceramic Head
Page 1 of 2
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
NOV 2 2 2006
Excia Total Hip System (Excia 36mm Ceramic Head) September 8, 2006
COMPANY:
Aesculap®, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714
CONTACT:
Kathy A. Racosky 800-258-1946 (phone) 610-791-6882 (fax) kathy racosky@aesculap.com (email)
TRADE NAME: Excia Total Hip System 36mm Ceramic Head
COMMON NAME: Ceramic Ball Head
CLASSIFICATION NAME: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous uncemented prosthesis Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate Prosthesis, hip, semi-constrained, metal/polymer, uncemented Prosthesis, hip, semi-constrained, metal/polymer, cemented
- REGULATION NUMBER: 888.3353, 888.3353, 888.3360, 888.3350
PRODUCT CODE: LZO, MEH, LWJ, JDI
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the 36mm Ceramic Head is a line extension of Aesculap's Excia Total Hip System that was cleared (K042344). It is also substantially equivalent to the Excia Total Hip System 12/14 Trunnion with Ceramic Head (K060918).
DEVICE DESCRIPTION
The Excia 36mm Ceramic Head is manufactured from ceramic (Al2O3) and conforms to ISO 6474. The 36mm diameter head is offered in three different head lengths (-3.5 mm, 0 mm, and +3.5mm). These ceramic heads allow the surgeon further option to meet the patient's needs.
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 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 with or with of u CaP®.
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))
The new 36mm ceramic head of the Excia Total Hip System are offered in similar shapes and sizes as the predicate devices. The material used for the Asecularia device is the same as that used to manufacture the predicate don'the .
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,
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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2006
Aesculap, Inc. % Ms. Kathy A. Racosky Regulatory Affairs Associate 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K062684 Trade/Device Namc: Excia Total Hip System 36mm Ceramic Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, JDI, LWJ, MEH Dated: November 14, 2006 Received: November 15, 2006
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 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
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Page 2 - Ms. Kathy A. Racosky
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.
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Parl 807.97). 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/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buechner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Excia Total Hip System 36mm Ceramic Head
Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
510(k) Number:________________________________________________________________________________________________________________________________________________________________
Device Name: Excia 36mm Ceramic Head
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 necosis 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 to 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 p CaP®.
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) | |
|---|---|
| (Division Sign-Off) | for MCM |
| Division of General, Restorative, and Neurological Devices |
510(k) Number K062684