Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

Device Description

The Revision Femoral Stem consists of a femoral stem and a modular neck, assembled together through a taper coupling stabilized by means of a safety screw. When used in total hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with modular femoral heads and compatible acetabular cups. When used in partial hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with a Lock Bipolar Head.

The stem is made of Ti6Al4V (ASTM F1472 – ISO 5832-3). The stem is straight, with a tapered profile, round finned section and a rounded tip to facilitate insertion. The external surface of the stem features a macro-roughened finishing obtained by sandblasting. Diameters ranging from 14 to 26 mm, with increases of 1 mm, for a total of 13 diameters are available. Two lengths (140 or 200 mm) for each diameter of the stem are available.

The neck is made of Ti6A14V (ASTM F1472 – ISO 5832-3). The same material is also used for the safety screw, which also has a small pin made of UHMWPE (ISO 5834-2, ASTM F648) to help prevent loosening of the safety screw. Two (2) versions of the neck are available , one with a CCD angle of 131° and another with a CCD angle of 135°. Both the neck versions are available in 7 different heights. Distally, the external surface of the neck component features a macro-roughened finishing obtained by sandblasting; proximally, the surface of the neck component is polished to reduce the chance of polyethylene wear particles if the neck accidentally rubs against the polyethylene of the acetabular component.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "Revision Femoral Stem." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria. Therefore, the information requested may not be fully available in this document.

Based on the provided text, here's what can be extracted and what is explicitly stated as not applicable or not provided:

1. A table of acceptance criteria and the reported device performance:

The document describes non-clinical testing designed to demonstrate substantial equivalence, not to meet specific performance acceptance criteria for a new clinical indication. The tests performed are those commonly used for implantable orthopedic devices.

Acceptance Criteria (Implied)	Reported Device Performance
Fatigue testing (ISO 7206-4) performance comparable to predicate	Device's ability to perform substantially equivalent to the predicate devices
Fatigue testing (ISO 7206-6) performance comparable to predicate	Device's ability to perform substantially equivalent to the predicate devices
Fretting evaluation performance comparable to predicate	Device's ability to perform substantially equivalent to the predicate devices
Analysis of disassembly torque of safety screw comparable to predicate	Device's ability to perform substantially equivalent to the predicate devices
Range of motion (ISO 21535) comparable to predicate	Device's ability to perform substantially equivalent to the predicate devices
LAL (Endotoxin) limit of 20EU/device	Subject device meet the specified 20EU/device limit

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample size for test set: The document refers to "non-clinical testing" (mechanical and LAL testing), which typically involves a number of physical samples rather than biological test sets. The specific number of mechanical test samples for each test (e.g., how many stems were fatigued) is not provided.
Data provenance: As this is non-clinical testing, there isn't a "country of origin of the data" in the sense of patient data. The manufacturer is Limacorporate S.p.A. in Italy, suggesting the testing likely occurred in a facility associated with the manufacturer or a contract testing laboratory.
Retrospective or prospective: This concept is not applicable to non-clinical mechanical or LAL testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This is not applicable as the document describes non-clinical mechanical and LAL testing, not studies requiring expert interpretation of clinical data to establish a ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable as the document describes non-clinical mechanical and LAL testing.

5. 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:

This is not applicable. The device is an orthopedic implant (femoral stem), not an AI algorithm or an imaging diagnostic tool that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is an orthopedic implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests, the "ground truth" is defined by the standards themselves (e.g., ISO 7206-4, ISO 7206-6, ISO 21535) and the physical properties and performance characteristics measured against those standards. For LAL testing, the ground truth is the specified endotoxin limit (20EU/device).

8. The sample size for the training set:

This is not applicable as the document describes non-clinical mechanical and LAL testing for an orthopedic implant, not an AI algorithm or a clinical study that would have a "training set."

9. How the ground truth for the training set was established:

This is not applicable for the reasons stated above.

Summary

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

February 10, 2017

Limacorporate S.p.A. Dr. Stephen Peoples President People & Associates- Stephen J. Peoples, VMD, MS 411 Auditorium Blvd. Winona Lake, Indiana 46590

Re: K161226

Trade/Device Name: Revision 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, LPH, KWY Dated: January 16, 2017 Received: January 18, 2017

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/Resourcesfor You/Industry/default.htm. 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 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.

Sincerely,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161226

Device Name

Revision Femoral Stem

Indications for Use (Describe)

☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Type of Use (Select one or both, as applicable)

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Summarv of Safety and Effectiveness

Date: February 06, 2017

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 SPeoples VMD @ gmail.com PEOPLE&ASSOCIATED CONSULTING, LLC 5010 LODGE POLE LANE FORT WAYNE INDIANA, 46814 USA Phone: 260-645-0327 FAX: +39 0432945512

Product	Common name	Product Code	Regulation and Classification Name
Revision FemoralStem	Femoral HipProsthesis	LZO	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis per 21 CFR888.3353
		LPH	Hip joint metal/polymer/metal semi-constrained porous-coated uncementedprosthesis per 21 CFR 888.3358
		KWY	Hip joint femoral (hemi-hip)metal/polymer cemented or uncementedprosthesis per 21 CFR 888.3390

Description:

The neck is made of Ti6A14V (ASTM F1472 – ISO 5832-3). The same material is also used for the safety screw, which also has a small pin made of UHMWPE (ISO 5834-2,

Traditional 510(k) - Revision Femoral Stem February 06, 2017

Section 5 - Page 20 of 578

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ASTM F648) to help prevent loosening of the safety screw. Two (2) versions of the neck are available , one with a CCD angle of 131° and another with a CCD angle of 135°. Both the neck versions are available in 7 different heights. Distally, the external surface of the neck component features a macro-roughened finishing obtained by sandblasting; proximally, the surface of the neck component is polished to reduce the chance of polyethylene wear particles if the neck accidentally rubs against the polyethylene of the acetabular component.

Indication For Use:

Predicate Devices:

Revision Femoral Stem cleared via K151739-Limacorporate S.p.A.

Comparable Features to Predicate Device(s):

The Revision Femoral Stem components share the same materials, intended use and design features as those of the predicate devices. Non-clinical testing demonstrates that the subject components perform at least as well as the cited predicate.

Non-Clinical Testing:

Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices in:

Fatigue testing (ISO 7206-4); -
Fatigue testing (ISO 7206-6); -
-Fretting evaluation:
Analysis of disassembly torque of safety screw; -
-Range of motion (ISO 21535).

LAL testing has been performed to establish that the subject device meet the specified 20EU/device limit.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of Revision Femoral Stem to the predicate device.

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.