The H-Max S stems are indicated for use in total hip arthroplasty and are intended for press-fit (uncemented) use. The H-Max S Stems are intended for use with Co-Cr-Mo femoral heads and Limacorporate standard and protruded cemented cups. The standard and protruded cemented cups are intended for cemented use only.

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

· non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
· rheumatoid arthritis;
· treatment of femoral head and neck fractures;
· revisions in cases of good remaining femoral bone stock.

Device Description

The H-MAX S femoral system consists of the H-MAX S femoral stem, a femoral head and an acetabular cup. The H-Max S Stems are intended for use with CoCrMo femoral heads and Limacorporate Cemented cups.

The H-MAX S femoral stem is a monolithic cementless stem made from Ti6Al4V (ISO 5832-3, ASTM F1472). The external surface has a macro-roughened surface. A layer of hydroxyapatite is applied along the length of the stem. The H-MAX S stem is manufactured in 11 sizes for each of two configurations (standard and lateralizing) that vary in the CCD angle.

AI/ML Overview

The provided document (K112091) is a 510(k) premarket notification for a medical device, the H-MAX S femoral hip system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and statistical performance measures.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the following points can be made based on the provided text:

A table of acceptance criteria and the reported device performance: This information is not present. The document describes mechanical testing performed, but it does not specify quantitative acceptance criteria or report specific performance values against such criteria. For example, it mentions "fatigue testing to demonstrate the strength" and "pull-off testing to demonstrate the strength of the taper connection," but not what specific load or cycle count was deemed acceptable.
Sample size used for the test set and the data provenance: This information is not present. The document states "All mechanical testing was done on worst case components or constructs," but it does not provide details on the number of samples tested or the origin of any materials other than that the device is manufactured by Limacorporate S.p.A. in Italy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as there was no clinical study described that would require expert-established ground truth. The testing was mechanical.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.
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 hip implant, not an AI-assisted diagnostic tool, and no clinical studies involving human readers or AI were performed or described.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hip implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical testing, the "ground truth" would be the engineering specifications and recognized test standards (e.g., ISO, ASTM), which the device aimed to meet. The document states, "Where possible, standard test methods were used to allow comparison to testing of the predicate devices."
The sample size for the training set: Not applicable. No clinical or AI-related training set was involved in this submission.
How the ground truth for the training set was established: Not applicable. No training set was involved.

Summary from the document:

The manufacturer performed non-clinical mechanical testing to demonstrate the substantial equivalence of the H-MAX S femoral hip system to predicate devices (specifically the Depuy Corail AMT Femoral stem). This testing included:

Fatigue testing on the femoral stem and neck.
Pull-off testing for the taper connection.
Simulation of the Range of Motion.
Characterization of the Hydroxyapatite coating according to FDA guidance.

The document explicitly states: "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the H-MAX S femoral hip system to the predicate devices." This is a key point for 510(k) submissions where the device is deemed substantially equivalent based on similarities in intended use, indications, design, materials, and non-clinical performance to an already legally marketed device.

Summary

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K112091

Summary of Safety and Effectiveness

Date: September 5, 2012

Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy

U.S. Contact Person:

9 2012 NOV

Cheryl Hastings Principal Consultant Phone: 574-527-4220

Product	Product Code	Regulation and Classification Name
H-Max S femoral hip system	MEH	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis per 21 CFR 888.3353
	JDI	Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3350

Description:

Intended Use:

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

· non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
· rheumatoid arthritis;
· treatment of femoral head and neck fractures;
· revisions in cases of good remaining femoral bone stock.

Traditional 510(k) - H-MAX S femoral hip system

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K112091 Page 2 of 2

Predicate Devices:

Corail AMT Femoral stem (Depuy, K042992)

Comparable Features to Predicate Device(s): the H-MAX S femoral hip system is similar to the predicate devices in terms of intended use, indications, design and materials.

The H-Max S stem and the Corail AMT stem are both indicated for use in total hip arthroplasty for press-fit (uncemented) use. Like the Corail AMT hip prosthesis, the H-MAX S femoral stem is a monolithic stem with a wide medial curvature and an A-P profile characterized by the "V" shape in the proximal part. Both prostheses are characterized by a 12/14 neck-head taper and the surface has a layer of Hydroxyapatite. The components of the H-MAX S femoral hip system are manufactured from the same materials as the predicate devices.

Non-Clinical Testing: The H-MAX S femoral hip system has undergone fatigue testing to demonstrate the strength of the femoral stem and the femoral neck. Pull-off testing to demonstrate the strength of the taper connection between the femoral stem and the modular CoCrMo heads has also been completed. A simulation of the Range of Motion has been performed to ensure the device design does not overly limit range of motion.

All mechanical testing was done on worst case components or constructs. Where possible, standard test methods were used to allow comparison to testing of the predicate devices. The testing results demonstrated the system's ability to perform under expected clinical conditions.

The Hydroxyapatite coating has been characterized according to the FDA guidance documents.

Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the H-MAX S femoral hip system to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing another person. The symbol is made up of three curved lines that form the shape of two figures.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Dated: November 9, 2012

Limacorporate SPA % Hastings Regulatory Consulting, LLC Ms. Cheryl Hastings Principal Consultant P.O. Box 696 Winona Lake, Indiana 46590-696

Re: K112091

Trade/Device Name: H-MAX S femoral hip system Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: MEH, JDI Dated: September 05, 2012

Received: October 01, 2012

Dear Ms. Hastings:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Cheryl Hastings

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.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Mark N. Melkerson

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

Enclosure

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510(k) Number (if known): K112091 --

Device Name: H-MAX S femoral hip system

Indications for Use:

H-MAX S femoral hip system Indications for Use

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

· non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
· rheumatoid arthritis;
· treatment of femoral head and neck fractures;
· revisions in cases of good remaining femoral bone stock. ·

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/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)

Signature

(Division Sign-Off) Division of Surgica' Orthopedic, and Restorative Devices

510(k) Number K112091

Page 1 of 1

Traditional 510(k) – H-MAX S femoral hip system September 5, 2012

Section 4 - Page 15 of 354

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.