EXCIA TOTAL HIP SYSTEM

K042344 · Aesculap, Inc. · LWJ · Mar 16, 2005 · Orthopedic

Device Facts

Record IDK042344
Device NameEXCIA TOTAL HIP SYSTEM
ApplicantAesculap, Inc.
Product CodeLWJ · Orthopedic
Decision DateMar 16, 2005
DecisionSESE
Submission TypeAbbreviated
Regulation21 CFR 888.3360
Device ClassClass 2
AttributesTherapeutic

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 Story

Total hip replacement system; replaces diseased or damaged hip joint. Components: femoral stems (cemented CoCr or uncemented Ti with plasma spray), acetabular cups (Ti with plasma spray), acetabular inserts (UHMWPE), and femoral heads (CoCrMo or ceramic). Distal centralizers (PMMA) maintain stem alignment in femoral canal. Used by orthopedic surgeons in clinical/surgical settings. Provides structural replacement of hip joint to restore mobility and reduce pain. Ceramic heads restricted to Ti cementless stems; CoCrMo heads compatible with both stem types. Acetabular screws optional for fixation.

Clinical Evidence

Bench testing only. Testing performed per FDA guidance for orthopedic devices, including metallic plasma-sprayed coatings, non-articulating modular components, acetabular cup prostheses, femoral stem prostheses, ceramic ball hip systems, and UHMWPE requirements.

Technological Characteristics

Materials: Ti, Ti plasma spray (Plasmapore), CoCrMo, UHMWPE, PMMA. Components: Femoral stems (cemented/uncemented), acetabular cups, acetabular inserts (symmetrical/asymmetrical), femoral heads (CoCrMo/ceramic). Distal centralizers for alignment. Fixation: Cemented or cementless. No software or electronic components.

Indications for Use

Indicated for patients with severe hip pain/disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of femoral head, nonunion of femoral fractures, congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, disability from previous fusion, or acute femoral neck fractures.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{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): K042344 ### 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
Innolitics
510(k) Summary
Decision Summary
Classification Order
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