The Master 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 Master Stems are intended for use with Co-Cr-Mo femoral heads and cemented cups or with Co-Cr-Mo femoral heads and Delta TT Acetabular System. When used in partial hip arthroplasty, the MasterSL stems are intended for use with 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;
· treatment of femoral head and neck fractures;
· revisions in cases of good remaining femoral bone stock.

Device Description

The Master femoral stem is a monolithic, collarless, tapered wedge shaped stem intended for press-fit uncemented partial or total hip arthroplasty. When used in total hip arthroplasty the stem is coupled to a Limacorporate Femoral Heads (K112158) and used with either a Limacorporate Cemented Cups (K112158) or Limacorporate Delta TT Acetabular System cup (K112898). When used in partial hip arthroplasty the Master" femoral stem is coupled to a Limacorporate Femoral Heads (K112158) and used with a Lock Bipolar Head (Limacorporate K112158).

The Master" femoral stem is made of Ti6A14V alloy conforming to ASTM F1472 - ISO 5832-3; the proximnal 1/2 of the stem a plasma sprayed coating of titanium alloy (ASTM F1472 - ISO 5832-3). The stem has a tapered rectangular section and the distal anterior and posterior surfaces have a vertical groove for rotational stability. The stem provides a neck with a 12/14 conical taper to couple to Limacorporate Femoral Heads and the necks are mirror-polished and lowered to reduce accidental abrasion and contact between the stem neck and the acetabular cup. The Master stems is available 13 sizes in both standard and lateralized versions with different CCD angles.

AI/ML Overview

Here's an analysis of the provided text regarding the MasterSL Femoral Stem, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance for MasterSL Femoral Stem

Disclaimer: The provided document is a 510(k) summary for a medical device (femoral stem). This type of submission primarily focuses on demonstrating "substantial equivalence" to a predicate device through non-clinical testing and comparison of design, materials, and intended use, rather than setting and meeting quantitative performance acceptance criteria through clinical studies typical for AI/software devices. Therefore, the tables below will reflect the nature of this submission.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a prosthetic implant, the "acceptance criteria" are related to compliance with recognized standards and similarity to predicate devices, rather than specific performance metrics (e.g., sensitivity, specificity) common in software or diagnostic device submissions.

Acceptance Criteria Category	Specific Acceptance Criteria (Method/Standard)	Reported Device Performance and Compliance
Material Composition	Ti6A14V alloy conforming to ASTM F1472 - ISO 5832-3.	The MasterSL femoral stem is made of Ti6A14V alloy conforming to ASTM F1472 - ISO 5832-3. Proximnal 1/2 has a plasma sprayed coating of titanium alloy (ASTM F1472 - ISO 5832-3).
Fatigue Resistance	According to ISO 7206-4 and ISO 7206-6.	The MasterSL stems were tested in worst-case configurations for fatigue resistance according to ISO 7206-4 and ISO 7206-6. (Implied
Pass/Compliance to standard, as no failure is reported and substantial equivalence was granted.)
Range of Motion (ROM)	Analysis using the worst-case construct.	The ROM of the MasterSL hip stem was analyzed using the worst-case construct. (Implied adequate ROM, as no issues reported and substantial equivalence was granted.)
Coating Characterization	Conformity to FDA guideline and referenced standards. (Specific standards not listed in the provided text).	The Titanium Plasma Spray coating was characterized to verify conformity to FDA guideline and referenced standards. (Implied Pass/Compliance.)
Substantial Equivalence (Overall)	Comparable to predicate devices in intended use, indications for use, design, and materials.	"The Master stems are substantially equivalent to the predicate devices in terms of intended use, indications for use, design and materials." Details on similarity to specific predicates provided in text.

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

Sample Size for Test Set: Not applicable. This submission relies on non-clinical (bench) testing and comparison to predicate devices, not human or animal clinical trials. The "test set" in this context refers to the physical devices subjected to fatigue and ROM testing. The number of physical units tested is not specified in this summary.
Data Provenance: Not applicable for a traditional "test set" as understood in a clinical study. The non-clinical tests were performed by the manufacturer, Limacorporate S.p.A. The origin is therefore the manufacturer's testing facilities in Italy.

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

Number of Experts: Not applicable. For non-clinical, bench testing of a medical implant, "ground truth" is established by adherence to recognized international standards (e.g., ISO, ASTM) and engineering principles, rather than expert consensus on a test set. The results of the physical tests themselves serve as the outcome.
Qualifications of Experts: Not applicable in the context of human expert review for "ground truth." The expertise involved would be in biomedical engineering, materials science, and quality assurance to conduct and interpret the non-clinical tests.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Since there's no clinical "test set" requiring expert review or labeling, there's no adjudication method in the sense of resolving discrepancies among human reviewers. Test results are typically evaluated against pre-defined criteria from the relevant standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. An MRMC study is relevant for evaluating the impact of a diagnostic or AI-assisted device on human interpretation (e.g., radiologists reading images). This submission is for a prosthetic hip stem and does not involve human readers interpreting data.
Effect Size of Human Readers' Improvement with AI vs. Without AI: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study Done: Not applicable. This device is a physical implant, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant. The "performance" is inherent in the physical properties of the implant itself.

7. Type of Ground Truth Used

Type of Ground Truth: For the non-clinical testing, the "ground truth" is defined by international engineering standards (e.g., ISO 7206-4, ISO 7206-6 for fatigue) and material specifications (e.g., ASTM F1472, ISO 5832-3 for Ti6A14V alloy). The tests simulate physiological conditions and material requirements. For the overall submission, the ground truth for substantial equivalence is the performance and characteristics of the legally marketed predicate devices.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The design of the MasterSL Femoral Stem is based on established engineering principles, clinical experience with similar implants, and perhaps internal design iterations, rather than machine learning from data.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary

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Summary of Safety and Effectiveness

Date: June 11, 2014

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

U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant Phone: 260-645-0327 FAX: +39 0432945512 JUN 1 0 2014

Product	CommonName	ProductCode	Regulation and Classification Name
MasterSLfemoral stem	Total orHemiHipProsthesis	LZO	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis per 21 CFR888.3353
		JDI	Hip joint metal/polymer semi-constrainedcemented prosthesis per 21 CFR888.3350
		KWY	Hip joint femoral (hemi-hip)metal/polymer cemented or uncementedprosthesis per 21 CFR 888.3390
		KWZ	Prosthesis, Hip, Constrained, CementedOr Uncemented, Metal/Polymer per 21CFR 888.3310
		LPH	Prosthesis, Hip, Semi-Constrained,Metal/Polymer, Porous Uncemented per21 CFR 888.3358

Description:

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neck with a 12/14 conical taper to couple to Limacorporate Femoral Heads and the necks are mirror-polished and lowered to reduce accidental abrasion and contact between the stem neck and the acetabular cup. The Master stems is available 13 sizes in both standard and lateralized versions with different CCD angles.

Intended Use:

The Master 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 MasterSL Stems are intended for use with Co-Cr-Mo femoral heads and cemented cups or with Co-Cr-Mo femoral heads and Delta TT Acetabular System. When used in partial hip arthroplasty, the MasterSL stems are intended for use with 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;
· treatment of femoral head and neck fractures;
· revisions in cases of good remaining femoral bone stock.

Predicate Devices:

. H-MAX S stems (Limacorporate, K112091):
. Encore Linear Hip (DJO, K972791 and K991325);
Modulus Femoral Hip System (Limacorporate, K112158); .
Taperloc 12/14 Taper Femoral Component (BIOMET, K043537). .

Comparable Features to Predicate Device(s):

The Master stems are substantially equivalent to the predicate devices in terms of intended use, indications for use, design and materials. As for all of the predicates, the Master stems is intended for use in total hip arthroplasty and like the Modulus Femoral Hip System predicate (K112158), it can also be used in partial hip arthroplasty. Like all of the predicates, the subject MasterSL stem is intended for press-fit cementless use.

The Master" stems are manufactured from the same materials as the predicate devices. The Master Stem has a tapered wedge design which is similar to all of the predicates exception that predicate Modulus stem is a 2-piece stem with the components coupled through a conical taper while the other predicates and the subject device are all one pice monolithic stems. Like all of the predicates, the subject device is available in standard and lateralized versions, with different CCD angles, offsets and sizes.

Non-Clinical Testing:

The Master stems were tested in worst case configurations for fatigue resistance according to ISO 7206-4 and ISO 7206-6.

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The ROM of the Master 5- hip stem was analyzed using the worst case construct.

The Titanium Plasma Spray coating was characterized to verify the conformity to FDA guideline and referenced standards.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Master St Femoral Stem to the predicate devices. -

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

June 10, 2014

Limacorporate S.p.A. % Stephen Peoples, VMD President Peoples and Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814

Re: K140975

Trade/Device Name: MasterSL Femoral Stem 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: LZO, JDI, KWY, KWZ, LPH Dated: February 25, 2014 Received: April 16, 2014

Dear Dr. Peoples:

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 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

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.

, ·

Sincerely yours,

Lori A. Wiggins

for 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): K140975 Device Name: Master SL Femoral Stem

Indications for Use:

MasterSL Femoral Stem 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)

Elizabeth L. Frankss

Division of Orthopedic Devices

Traditional 510(k) - Master JL Femoral Stem

Page 1 of 1

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.