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.

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.

AI/ML Overview

The provided text describes the "Excia Total Hip System" and its clearance through the 510(k) premarket notification process by the FDA. This specific document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already legally marketed devices, rather than presenting de novo clinical study data to prove novel acceptance criteria.

Therefore, the document does not contain information about:

A table of acceptance criteria and reported device performance directly.
Sample sizes used for a test set or its data provenance.
Number of experts or their qualifications for establishing ground truth.
Adjudication methods.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
Standalone algorithm performance.
Type of ground truth used (pathology, outcomes data, etc.) for this particular device's testing (as it relies on equivalence).
Sample size for a training set or how its ground truth was established, because it is comparing to previously approved predicate devices, not training an AI algorithm.

Instead, the provided text indicates that the device met acceptance criteria by demonstrating substantial equivalence to existing predicate devices through comprehensive non-clinical testing.

Here's an overview of how the "acceptance criteria" are addressed in the context of this 510(k) submission:

Acceptance Criteria and Device Performance (Demonstrated by Substantial Equivalence):

The acceptance criteria for the Excia Total Hip System are implicitly that it performs as safely and effectively as its predicate devices, as demonstrated by meeting relevant industry standards and guidance documents for orthopedic implants.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Performance and Durability (e.g., fatigue, wear, strength, fixation) in accordance with relevant standards.	All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were executed. Additionally, testing adhered to specific guidance documents for: - Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement - Metallic Plasma Sprayed Coatings on Orthopedic Implants - "Mechanically Locked" Modular Implant Components - Acetabular Cup Prostheses - Femoral Stem Prostheses - Ceramic Ball Hip Systems - Ultrahigh Molecular Weight Polyethylene (UHMWPE) These tests confirmed the device's mechanical integrity and performance characteristics are comparable to or meet the requirements established for substantially equivalent predicate devices.
Biocompatibility (Material safety)	Implied by the use of standard materials like CoCr, Ti, Ti plasma spray, UHMWPE, and PMMA, which are well-established in orthopedic implants and have documented biocompatibility. No specific new testing is detailed, but adherence to guidance documents suggests material safety was considered.
Clinical Indications for Use (Safety and Effectiveness for specific patient populations)	The indicated uses for the Excia Hip System (rheumatoid arthritis, osteoarthritis, traumatic arthritis, avascular necrosis, etc.) are consistent with those of the predicate devices. The FDA's 510(k) clearance confirms substantial equivalence for these indications.

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is primarily a non-clinical performance evaluation and a demonstration of substantial equivalence to predicate devices, rather than a de novo clinical trial with human subjects.

Sample Size Used for Test Set and Data Provenance: Not applicable in the context of this 510(k) summary, as it describes non-clinical testing against established standards and comparison to predicate devices, not a clinical test set from human data. The "test set" would consist of the device components themselves undergoing specified mechanical and material tests.
Number of Experts Used to Establish Ground Truth & Qualifications: Not applicable. Ground truth is established by engineering standards, material science, and the documented performance of predicate devices.
Adjudication Method: Not applicable. Performance is measured against predetermined physical properties and regulatory standards.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a medical device (hip replacement system), not an AI algorithm requiring MRMC studies.
Standalone Performance (Algorithm Only): Not applicable, as this is a physical implant, not an algorithm.
Type of Ground Truth Used: The ground truth is rooted in established engineering standards, material specifications, and the historical performance and regulatory clearance of the predicate devices. This includes mechanical properties, material composition, wear rates, and fixation attributes, as defined by the various guidance documents listed.
Sample Size for Training Set: Not applicable. This device is not an AI algorithm and therefore does not have a "training set."
How Ground Truth for Training Set was Established: Not applicable.

Summary of the Substantial Equivalence Claim:

Aesculap believes the Excia Total Hip System is substantially equivalent in design and performance to the following predicate devices:

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)

The FDA's clearance (K042344) indicates their agreement that the Excia Total Hip System is substantially equivalent to these predicate devices for its intended use. This substantial equivalence determination is the primary "proof" that the device meets the necessary safety and effectiveness criteria for market entry under the 510(k) pathway.

Summary

{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

DEVICE DESCRIPTION

{1}------------------------------------------------

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

Regulation Number and Section

§ 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.