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 without u-CaP®.

Device Description

The Excia M and ML femoral stem are available in one design. The femoral stem is manufactured from TI with a plasma spray coating (Plasmapore) with U-CaP®. The Excia M and ML femoral stem will be offered in an 8/10 or 12/14 taper. This component is intended for uncemented use.

AI/ML Overview

The provided text is a 510(k) summary for the Excia Total Hip System M and ML Femoral Stem. It describes the device, its intended use, and substantial equivalence to predicate devices. However, the document does not include specific acceptance criteria, performance metrics, or details about a study designed to prove the device meets those criteria.

Instead, the "Performance Data" section states that:

"All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable."
It lists several other guidance documents for orthopedic implant testing that were followed.

This indicates that the device underwent a battery of standardized tests required by the FDA for orthopedic implants. However, the document does not present:

A table of specific acceptance criteria (e.g., minimum fatigue strength, maximum wear rate).
Any reported device performance against such specific criteria.
Details about a clinical study with human subjects or a comparison to AI.

Therefore, I cannot provide the requested information for the following points based only on the provided text:

A table of acceptance criteria and the reported device performance: Not explicitly stated.
Sample size used for the test set and the data provenance: Not mentioned. The testing refers to physical/mechanical performance rather than clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is related to mechanical testing, not expert-adjudicated clinical data.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as the testing described is mechanical.
The sample size for the training set: Not applicable. This is not a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The document indicates that the Excia Total Hip System M and ML Femoral Stem met necessary performance data requirements by undergoing various mechanical and material tests in accordance with FDA guidance documents for orthopedic devices. However, it does not specify the exact performance metrics or acceptance criteria for those tests, nor does it describe any studies involving human subjects, AI systems, or expert consensus adjudication. This 510(k) emphasizes substantial equivalence based on material, design, and indications for use, supported by adherence to recognized testing standards for physical implants.

Summary

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Excia Total Hip System M and ML Femoral Stem

K092143

Page 1 of 2

510(k) SUMMARY (as required by 21 CFR 807.92) B.

SEP 2 2 2009

Excia Total Hip System M and ML Femoral Stem

July 13, 2009

Aesculap Implant Systems, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311

CONTACT: Kathv A. Racosky 610-984-9291 (phone) 610-791-6882 (fax) kathy racosky@aesculap.com (email)
TRADE NAME: Excia Total Hip System
COMMON NAME: Femoral Hip Stem
Hip ioint Metal/Ceramic/Polymer Semi-Constrained CLASSIFICATION NAME: Cemented or Non-Porous Uncemented Prosthesis

REGULATION NUMBER: 888.3353

PRODUCT CODE: LZO, LWJ, MEH, KWY

SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, Inc. believes that Excia M and ML femoral stem is a line extension of Aesculap Implant Systems Excia (K042344, K060437, K060918, and K061344).

DEVICE DESCRIPTION

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K092143

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 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®.

TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))

The new Excia M and ML femoral stems of the Excia Total Hip System are offered in similar shapes and sizes as the predicate devices. The material used for the Aesculap Implant Systems device is the same as that used to manufacture the predicate devices.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.

SEP 2 2 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Aesculap Implant Systems, Inc. % Ms. Kathy A. Racosky Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K092143

Trade/Device Name: Excia Total Hip System M and ML Femoral Stem 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, LZO, LWJ, KWY Dated: August 25, 2009

Received: August 26, 2009

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 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2 -- Ms. Kathy A. Racosky

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Oarlare buelup

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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A. INDICATIONS FOR USE STATEMENT

K092143 510(k) Number:

Device Name: Excia Total Hip System M and ML Femoral Stem

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 .

Sonata for mxn

(Division Signe (DWision Sign-Oir)
Division of Surgical, Orthopedic, Division of Survices

510(k) Number K092143

and/or Over-the-Counter Use × 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)

Regulation Number and Section

§ 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.