(198 days)
No
The 510(k) summary describes a standard hip replacement system with different material and fixation options. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The performance studies listed are standard mechanical and material testing for orthopedic implants.
Yes
The device is described as "The Excia Hip System is intended to replace a hip joint" and is indicated for patients suffering from severe hip pain and disability due to various conditions, as well as those with congenital hip dysplasia, previous fusion, or acute femoral neck fractures. Replacing a diseased or damaged joint to alleviate pain and restore function is a therapeutic intervention.
No
This device is an Excia Hip System, which is an orthopedic implant intended to replace a hip joint in patients with various conditions causing severe hip pain and disability. Its purpose is treatment, not diagnosis.
No
The device description clearly details physical components made of materials like CoCr, Ti, PMMA, and UHMWPE, indicating it is a hardware medical device.
Based on the provided information, the Excia Hip System is not an IVD (In Vitro Diagnostic) device.
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 involving the implantation of a medical device into the body.
- Device Description: The device components (femoral stems, acetabular cup, inserts, femoral heads) are all physical implants designed to replace anatomical structures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Excia Hip System does not perform any such function.
The Excia Hip System is clearly an implantable orthopedic 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 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 to previous fusion .
- . Patients with acute femoral neck fractures
The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and is intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti with a Ti plasma spray.
Product codes (comma separated list FDA assigned to the subject device)
LWJ, JDI, LZO
Device Description
The Excia Total Hip System is available with two femoral designs. One is manufactured from Ti with a Ti plasma spray coating (Plasmapore). 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 as well. Acetabular cup screws can be used for further cup fixation. The acetabular inserts are UHMWPE and available in symmetrical and asymmetrical designs.
Two femoral heads are available. The CoCrMo heads may be used with either the cemented or cementless femoral stems. However, the ceramic heads are for use only with the Ti alloy cementless stems.
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 Document for Testing Acetabular Cup Prostheses", .
- . "Draft Guidance for Femoral Stem Prostheses" .
- "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball . Hip Systems" and
- "Data Requirements for Ultrahigh Molecular Weigt Polyethylene (UHMWPE) Used in . Orthopedic Devices" 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.
BiCONTACT Hip System (K040191)
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.
K022077, K030373, K031474, K022902, K031495, K013475
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
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
MAR 1 6 1005
KO42344
PAGE 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990
EXCIA TOTAL HIP SYSTEM
February 25, 2005
Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034
- CONTACT: Joyce Kilroy; Dir of RA & QA 800-258-1946 (phone) 610-791-6882 (fax) joyce.kilroy@aesculap.com (email)
TRADE NAME: Excia Total Hip System
COMMON NAME: Hip System
DEVICE CLASS: CLASS II
PRODUCT CODE: LWJ, JDI, LZO
CLASSIFICATION: 888.3350, 888.3353
REVIEW PANEL: Orthopedics
INTENDED 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 to previous fusion .
- . Patients with acute femoral neck fractures
The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and is intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti with a Ti plasma spray.
DEVICE DESCRIPTION
The Excia Total Hip System is available with two femoral designs. One is manufactured from Ti with a Ti plasma spray coating (Plasmapore). 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
The acetabular cup (Plasmacup) is manufactured from Ti and is coated with Plasmapore as well. Acetabular cup screws can be used for further cup fixation. The acetabular inserts are UHMWPE and available in symmetrical and asymmetrical designs.
Two femoral heads are available. The CoCrMo heads may be used with either the cemented or cementless femoral stems. However, the ceramic heads are for use only with the Ti alloy cementless stems.
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", .
- . "Draft Guidance for Femoral Stem Prostheses" .
- "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball . Hip Systems" and
- "Data Requirements for Ultrahigh Molecular Weigt Polyethylene (UHMWPE) Used in . Orthopedic Devices" was completed where applicable.
SUBSTANTIAL EQUIVALENCE
Aesculap believes that the new Excia Total Hip System is substantially equivalent in design to:
- . BiCONTACT Hip System (K040191)
- 36mm V40 Femoral Head Components (K022077) .
- Alloclassic Zweymueller (K030373) .
- . SC Total Hip System (K031474)
- . Smith & Nephew Hip System (K022902)
- . Pinnacle Duofix HA Acetabular Cup (K031495)
- . Trident Porous Ti Acetabular Component with Coating (K013475)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2005
Ms. Joyce Kilroy Mis. Joyce IIInoulatory Affairs & Quality Assurance Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K042344 Trade/Device Name: Excia Total Hip System Regulation Number: 21 CFR 888.3353; 21 CFR 888.3350 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or ITIP Joint metal corains prosthesis; Hip joint metal/polymer semiconstrained cemented prosthesis Regulatory Class: II
Product Code: LZO, JDI, LWJ Dated: February 25, 2005 Received: February 25, 2005
Dear Ms. Kilroy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your becamed the device is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encrosure) to regars comment date of the Medical Device Amendments, or to comments provide to May 20, 1978, the exact and on the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). allo Cosmetic Acr (Free) market the device, subject to the general controls provisions of the Act. The 1 ou may, merelore, manel and not include requirements for annual registration, listing of general controls provisioning 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to back added as a legulations, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Obacements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r icase be devilsed that I Dr. Pressan that your device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must or any I odotal statutes and registments, 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. Joyce Kilroy
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) This letter will allow you to oegill marketing your arrive of your device of your device to a legally premarket notification. The PDA inding of substance of 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 If you desire specific advice for your at 240-276-0120. Also, please note the regulation entitled, comaci the Office of Comphalloo at 210 = 10 = 21 = 2 = 2 = 2 = 2 = 2 = 2 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = $ Small " Misofanding by Icrerches to premantonions.com the Act from the Division of Small other gelleral information on your response in the toll-free number (800) 638-204 or
Manufacturers, International and Consumer Assistance at its to the program of the progra Manufacturels, International and Consumer Pisotows. Ida.gov/cdrh/industry/support/index.html.
Sincerely yours,
J. Mark A. Millerson
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Excia Hip System
Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Excia Total Hip System
Indication 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 o 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 CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti with a Ti plasma spray.
| Prescription Use | X | or | Over-the-Counter Use |
|---|---|---|---|
| (per 21 CFR 801.109) |
for Mark A. Millan
(Division Sign-Off)
Division of General, Restorative, and Neuro
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number K042344