The MODULUS stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Modulus Stems are intended for use with Co-Cr-Mo femoral heads and a compatible acetabular cup. When used in partial hip arthroplasty, the Modulus Stems are intended for use with the Lock Bipolar Heads.

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;
osteoarthritis after femoral heads fractures; .
correction of functional deformity; ●
revisions in cases of good remaining femoral bone stock. ●

The Limacorporate Cemented Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs reconstruction.

Device Description

The Modulus femoral hip system consists of modular femoral hip prostheses, modular CoCrMo heads, cemented UHWMPE cups (for use in total hip arthroplasty) and bipolar heads (for use in partial or hemi-hip arthroplasty).

The Modulus femoral hip prosthesis consists of a femoral stem component and a femoral neck component combined by a Morse taper locking mechanism. A locking screw is provided to improve the security of fixation. The MODULUS femoral hip prosthesis is intended for cementless use in hip joint arthroplasty.

The femoral stem has a 5° conicity with a round finned section. It is made of Ti6A14V (ISO 5832-3, ASTM F1472) and is sandblasted. The stem is available in 11 sizes with diameters ranging from 16 to 26 mm with a 1 mm increment.

The femoral neck is available in two cervico-diaphyseal configurations (125° and 135°) and two lengths (42 and 48 mm). It is made of Ti6Al4V (ISO 5832-3, ASTM F1472). The proximal portion of the neck is highly polished while the distal portion is macroroughened.

Modular heads are manufactured from CoCrMo (ASTM F1537). They are characterized by a spherical shape and are used with an acetabular cup in total hip arthroplasty. The femoral heads are coupled with the MODULUS hip prosthesis by means of a 12/14 Morse taper. They are available in diameters of 28, 32 and 36 mm and in offset sizes S. M, L, XL.

Cemented cups are manufactured entirely of UHMWPE (ASTM F648, ISO 5834-2).

The acctabular cups are available in two different versions: standard and protruded. The standard version is hemispherical and is designed for use in deep acetabula. The protruded version has a lateral portion designed to resist dislocation.

An AISI 316-L stainless steel ring is inserted in the equatorial region to allow the evaluation of the device position through radiography.

Lock Bipolar Heads are modular prostheses characterized by an external shell made from CoCrMo (ASTM F1537) and by a conical liner made from UHMWPE (ASTM F648, ISO 5834-2). A retentive ring allows the shell to assemble with modular heads. Lock Bipolar heads are available in 13 sizes from 45 to 57 mm with a 1 mm increment.

AI/ML Overview

The provided document, K112158, describes the Modulus Femoral Hip System. It is a 510(k) premarket notification, which means the manufacturer is seeking to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness. Therefore, the information provided focuses on comparative features and non-clinical testing, rather than an acceptance criteria study with clinical endpoints as might be seen for novel devices or PMAs.

Here's an analysis based on the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Device Performance and Standards)	Reported Device Performance (Non-Clinical Testing)
Femoral Stem Strength	Must withstand expected physiological loads without failure.	Underwent fatigue testing to demonstrate strength. (Details on specific load limits or cycle counts are not provided, but the statement implies successful completion.)
Modular Connection Strength	Morse taper and locking screw mechanism must maintain secure fixation.	Underwent fatigue testing to demonstrate strength of modular connections. (Details not provided, but implied successful.)
Lock Bipolar Head Disassembly Force	Must resist disengagement under expected forces.	A pull-out test was performed to test the force necessary to disassemble the Lock bipolar head. (Specific force values or pass/fail thresholds are not provided, but implied successful.)
Range of Motion	Device design should not excessively limit hip range of motion.	A simulation of the Range of Motion has been performed to ensure the device design does not overly limit range of motion. (Details not provided, but implied successful.)
Materials Biocompatibility	Materials must be biocompatible and safe for implantation.	Components manufactured from the same materials as predicate devices (Ti6A14V, CoCrMo, UHMWPE). (This is a comparative criterion, indicating presumed biocompatibility based on predicate use.)
Mechanical Compatibility	Device components must be mechanically compatible with each other and indicated predicate components (e.g., DJO FMP acetabular cups).	Modulus femoral prostheses and modular CoCrMo heads are compatible with the DJO FMP acetabular cups.
Functional Equivalence	Intended use, indications, design, and materials are similar to predicate devices.	The Modulus femoral hip system is similar to the predicate devices in terms of intended use, indications, design and materials.

Note: The acceptance criteria are largely implicit in a 510(k) submission. For medical devices seeking substantial equivalence, the "acceptance criteria" are often met by demonstrating that the device performs as well as, or better than, the predicate device in relevant non-clinical tests, or that any differences do not raise new questions of safety or effectiveness. Specific numerical thresholds for fatigue, pull-out, etc., are usually defined in the test protocols used by the manufacturer, which are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: For the non-clinical testing, the document states "All mechanical testing was done on worst case components or constructs." This implies multiple samples of specific components were tested, but no specific number of samples (sample size) is provided for each test (fatigue, pull-out, range of motion simulation).
Data Provenance: The testing was conducted by the manufacturer, Limacorporate S.p.A. (Italy). No information on country of origin of clinical data is relevant as no clinical testing was performed or deemed necessary. All data is prospective in the sense that it was generated for the 510(k) submission, not collected from existing patient records.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This point is not applicable to this submission. Since no clinical testing was performed, there was no "ground truth" to be established by clinical experts for a test set. The validation of the device relies on non-clinical mechanical testing and comparison to predicate devices, overseen by internal engineering and regulatory experts at the manufacturer, and subsequently reviewed by FDA experts.

4. Adjudication Method for the Test Set

This point is not applicable. No clinical test set requiring expert adjudication for ground truth was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Modulus femoral hip system to the predicate devices." MRMC studies are typically for evaluating human performance (e.g., radiologists interpreting images) with and without AI assistance, which is outside the scope of this device type and submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable as the device is a physical medical implant (hip system), not a diagnostic algorithm or AI system. Its "performance" is mechanical and clinical outcome-based in patients, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance validation is primarily based on engineering standards, accepted mechanical test methods (e.g., for fatigue, pull-out), and the established safe and effective performance of its predicate devices. By demonstrating that its mechanical properties are comparable and meet relevant standards, and that its design and materials are substantially equivalent to predicates, it establishes its "ground truth" for safety and effectiveness in the context of a 510(k). No pathology or outcomes data from human subjects was used for this particular submission.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process are informed by engineering principles, material science, and prior successful designs (predicates).

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for an AI/ML algorithm.

Summary

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K112158

Summary of Safety and Effectiveness

Date: April 26, 2012

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

U.S. Contact Person: Cheryl Hastings Principal Consultant Phone: 574-527-4220

Product	Product Code	Regulation and Classification Name
MODULUS FemoralHip System	JDI	Hip joint metal/polymer semi-constrainedcemented prosthesis per 21 CFR 888.3350
	KWY	Hip joint femoral (hemi-hip) metal/polymercemented or uncemented prosthesis per 21 CFR888.3390
	LPH	Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis per 21CFR 888.3358
	KWZ	Hip joint metal/polymer constrained cementedor uncemented prosthesis per 21 CFR 888.3310

Description:

Traditional 510(k) - MODULUS Femoral Hip System April 26, 2012

p. 1 of 4

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K11 2158

Cemented cups are manufactured entirely of UHMWPE (ASTM F648, ISO 5834-2).

An AISI 316-L stainless steel ring is inserted in the equatorial region to allow the evaluation of the device position through radiography.

The following table shows the availability of the cemented cup diameters for each type of cup.

Cup Type	Inner diameter	Range of Outer Diameter
Standard Cups	28 mm	44-58 mm with increments of 2 mm
	32 mm	50-58 mm with increments of 2 mm
Protruded Cups	28 mm	44-58 mm with increments of 2 mm
	32 mm	50-58 mm with increments of 2 mm

The Modulus femoral prostheses and modular CoCrMo heads are also compatible with the DJO FMP acetabular cups, previously cleared in K974093, K974095, K973119, K023794 and K072154.

Intended Use: The Modulus femoral hip prosthesis is indicated for use in partial or total hip arthroplasty and is intended for press-fit (uncemented) use. When used in total hip arthroplasty, the MODULUS hip prosthesis is intended for use with a Co-Cr-Mo femoral head and a compatible acetabular cup. When used in partial hip arthroplasty, the MODULUS hip prosthesis is intended for use with a Lock Bipolar Head.

The Modulus femoral hip system is indicated for use in the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular . necrosis and hip dysplasia;
. rheumatoid arthritis;
. osteoarthritis after femoral heads fractures;
correction of functional deformity; .
revisions in cases of good remaining femoral bone stock. .

Traditional 510(k) - MODULUS Femoral Hip System April 26, 2012

p. 2 of 4

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K112158

The Limacorporate Cemented Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs reconstruction.

The DJO FMP acetabular cups are intended for press-fit (uncemented) use.

Predicate Devices:

Keystone Hip (Encore Medical, L.P., K000521) PROFEMUR R femoral system (Wright Mcdical Technology, K041114-K091423) WAGNER CONE stem (Centerpulse orthopaedics, K032380). Modular Revision Hip Stem (Encore Medical, L.P., K092331) Articul/eze femoral heads (Depuy, K883460-K980513) PE-Plus acetabular cups (Plus Orthopaedics, K992153) ZCA All Poly Acetabular Cup (K030153) Global Bipolar system (Smith & Nephew, K023743) Bipolar (Encore Orthopedics Inc. K953510) Foundation porous coated hemispherical shell (Encore Orthopedics, Inc., K974093) Foundation porous coated flared rim shell (Encore Orthopedics, Inc., K974095) Foundation porous acetabular system (Encore Orthopedics, Inc., K973119) Constrained liner (Encore Medical, L.P.,K023794) Foundation (FMP) porous coated spiked acetabular system (Encore Medical, L.P., K072154)

Comparable Features to Predicate Devices: the Modulus femoral hip system is similar to the predicate devices in terms of intended use, indications, design and materials.

The Modulus femoral prosthesis and the predicate femoral prostheses are indicated for use in hip arthroplasty and for press-fit (uncemented) use. The CoCrMo heads and the predicate heads are all indicated for use in total hip arthroplasty, while the Lock Bipolar heads and the predicate bipolar heads are all indicated for use in partial hip arthroplasty. The cemented cups and the predicate acetabular cups are intended for cemented use in hip arthroplasty where the acetabular socket needs reconstruction.

Like the Keystone Hip, the Profemur R femoral system and the Modular Revision Hip system, the Modulus femoral prosthesis is a modular prosthesis made up of a cylindrical stem and a proximal body that are joined through a taper connection stabilized by a safety screw. As with the predicates devices, the Modulus prosthesis is characterized by a 12/14 neck-head taper. The ccmented cups and the predicate cups are all monolithic and are characterized by several grooves in the outer surface to enhance fixation and rotational stability of the cup in bone cement. Like the Global Bipolar System, the Lock Bipolar heads are modular devices composed of an external shell, an inner liner and a locking mechanism.

The components of the Modulus femoral hip system are manufactured from the same materials as the predicate devices.

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K112158

Non-Clinical Testing: The Modulus femoral hip system has undergone fatigue testing to demonstrate the strength of the femoral stem and the strength of the modular connections. A pull-out test was performed to test the force necessary to disassemble the Lock bipolar head. 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.

Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Modulus femoral hip system to the predicate devices.

Traditional 510(k) – MODULUS Femoral Hip System April 26, 2012

., $4.4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

LimaCorporate S.p.A. % Ms. Cheryl Hastings Principal Consultant P.O. Box 696 Winona Lake, Indiana 46590

1 0 2012 A AY

Re: K112158

Trade/Device Name: Modulus stems, necks, heads, and cups Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

Regulatory Class: II Product Code: LPH, JDI, KWY, KWZ Dated: March 30, 2012 Received: April 4, 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 or uny receir sthe Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Cheryl Hastings

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 (OS) 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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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KILL 58 510(k) Number (if known): Unichown

Device Name: MODULUS Femoral Hip System

Indications for Use:

MODULUS 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;
osteoarthritis after femoral heads fractures; .
correction of functional deformity; ●
revisions in cases of good remaining femoral bone stock. ●

The Limacorporate Cemented Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs reconstruction.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)
--------------------------------------------------------	--

A.J.R

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_K 112158

Page 1 of 1

Traditional 510(k) - MODULUS Femoral Hip System April 23, 2012

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.