(29 days)
Not Found
No
The 510(k) summary describes a mechanical hip replacement system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies listed are related to mechanical and material testing of the implant components.
Yes
The device is described as a hip replacement system, intending to replace a hip joint for patients suffering from various hip-related conditions, which directly addresses a medical problem.
No
The Excia Hip System is an orthopedic implant designed to replace a hip joint, not to diagnose medical conditions.
No
The device description clearly outlines multiple hardware components made of various materials (CoCrMo, Ti, PMMA, UHMWPE) intended for surgical implantation to replace a hip joint. There is no mention of software as a component of this 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 implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details the components of a hip replacement system (femoral stems, acetabular cup, inserts, femoral heads). These are physical implants designed to be surgically placed in the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro testing.
Therefore, the Excia Hip System is a surgical implant, not an In Vitro Diagnostic device.
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
87MEH
Device Description
The Excia Total Hip System is available with two femoral designs. One is manufactured from Ti with a plasma spray coating (Plasmapore) with or with out u-CaP®. This component is intended for uncemented use. The other femoral component design is manufactured from CoCrMo and is intended for cemented use. Distal centralizers maintain the stem's alignment in the femoral canal. The centralizers are manufactured from PMMA.
The acetabular cup (Plasmacup) is manufactured from Ti and is coated with Plasmapore with or without u-CaP® as well. Acetabular cup screws can be used for further cup fixation. The acetabular inserts are UHMWPE and are available in symmetrical and asymmetrical designs.
Two femoral heads are available. The CoCrMo and ceramic head can be used with the cemented femoral component. The CoCrMo head can also be used with the Cementless femoral stem.
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)
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 for Femoral Stem Prostheses", .
- "Draft Guidance for Calcium Phosphate (Ca-P) Coating" was completed where applicable. .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Kobo437
Page 1 of 2
MAR 2 2, 2006
510(k) SUMMARY (as required by 21 CFR 807.92) D.
EXCIA TOTAL HIP SYSTEM with u-CAP®
February 20, 2006
| COMPANY: | Aesculap ® , Inc.
3773 Corporate Parkway
Center Valley, PA 18034 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky, Regulatory Affairs Associate
800-258-1946 (phone)
610-791-6882 (fax)
kathy.racosky @ aesculap.com (email) |
| TRADE NAME: | Excia |
| COMMON NAME: | Excia Total Hip System with $ \mu $ -CaP® |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 87MEH |
| CLASSIFICATION: | 888.3353 |
| REVIEW PANEL: | Orthopedic |
INTENDED 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®.
DEVICE DESCRIPTION
The Excia Total Hip System is available with two femoral designs. One is manufactured from Ti with a plasma spray coating (Plasmapore) with or with out u-CaP®. This component is intended for uncemented use. The other femoral component design is manufactured from CoCrMo and is intended for cemented use. Distal centralizers maintain the stem's alignment in the femoral canal. The centralizers are manufactured from PMMA.
1
Page 2 of 2
The acetabular cup (Plasmacup) is manufactured from Ti and is coated with Plasmapore with or without u-CaP® as well. Acetabular cup screws can be used for further cup fixation. The acetabular inserts are UHMWPE and are available in symmetrical and asymmetrical designs.
Two femoral heads are available. The CoCrMo and ceramic head can be used with the cemented femoral component. The CoCrMo head can also be used with the Cementless femoral stem.
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 for Femoral Stem Prostheses", .
- "Draft Guidance for Calcium Phosphate (Ca-P) Coating" was completed where applicable. .
SUBSTANTIAL EQUIVALENCE
The Aesculap Excia Total Hip System with µ-CaP® is essentially identical to the Excia Total Hip System (K042344), BiContact Hip System with u-CaP (K043079), and Trident Acetabular Shells: PS-HA (K001448).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2006
Aesculap, Incorporated c/o Ms. Kathy A. Racosky Regulatory Affairs Associatc 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K060437
Trade/Device Name: Excia Total Hip System with µ-CaP® 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 Dated: February 20, 2006 Received: February 24, 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 docs 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); good manufacturing practice requirements as set
3
Page 2 - Ms. Kathy A. Racosky
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 Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Hecker Lemmer to
Mark N. Melkerson 加 Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
B. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Excia Total Hip System with u-Cap®
Indication 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 µ CaP®.
Prescription Use ×
(Part 21 CFR 801 Subpart D)
or Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulud Lemer
Division of General, Restorative and Neurological Devices
(Optional Format 3-10-98)
510(k) Number K060437