Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.

Device Description

Subject of this Abbreviated 510(k) premarket notification is the Modular Proximally Fluted Hip Stem. The subject device is a line addition to the MDF Revision Hip System cleared via premarket notification K081124. The Modular Proximally Fluted Hip Stem is a straight, tapered, distally fixed stem with a modular female 12/14 neck taper. The subject device is manufactured from titanium alloy (Ti-6Al-4V) and has a grit-blast finish. The stems will be available in lengths of 240mm and 300mm in sizes 12-27. The subject devices will mate with the cobalt chrome modular necks cleared with the MDF Revision Hip Stems in premarket notification K081124, but are not designed to utilize the modular sleeves included as part of the MDF Revision Hip System.

AI/ML Overview

The provided text describes the Smith & Nephew Modular Proximally Fluted Hip Stem, an orthopedic implant. However, it does not contain information about acceptance criteria for device performance, nor does it detail a study proving the device meets specific acceptance criteria in the context of an AI/ML device.

The document discusses performance data related to the mechanical integrity of the hip stem, not an AI or software-based medical device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, AI multi-reader multi-case studies, ground truth for training) are not applicable to the content provided.

Here's a breakdown of the information that can be extracted, and where the requested information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical fatigue (e.g., environmental corrosion fatigue, fatigue strength)	"A review of the testing and analysis has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." Specific quantitative raw values for resistance to fatigue are not provided, only a general statement of satisfactory performance.
Post-fatigue pull-off strength	"A review of the testing and analysis has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." Specific quantitative raw values are not provided.
Range of Motion	"The range of motion of the subject device was also evaluated." Specific quantitative raw values are not provided.

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

Sample Size: Not specified. The document states "Performance testing has been conducted," but does not mention the number of units tested.
Data Provenance: Not applicable in the context of patient data for an AI/ML device. For the mechanical tests, the data was generated internally by Smith & Nephew.

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

Not applicable. This is a mechanical device, and "ground truth" in the AI/ML sense (e.g., expert consensus on images) is not relevant. The "review of the testing and analysis" would have been performed by engineers or scientists familiar with the test methods and device specifications.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. This refers to consensus building among experts for labeling data, which is not relevant for mechanical testing of a hip stem.

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

No, an MRMC study was not done. The document explicitly states "Clinical data was not needed to support the safety and effectiveness of the subject devices." MRMC studies are relevant for evaluating diagnostic software where human readers are involved.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

Not applicable. This device is not an algorithm.

7. Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the mechanical performance of the device would be the physical properties and behavior of the tested samples as measured against predetermined engineering specifications and industry standards (e.g., ISO standards for implants, though not explicitly cited, the guidance documents imply this). This is not "expert consensus" or "pathology" in the medical sense.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary of what the document does provide regarding performance and equivalence:

Guidance Documents: Performance testing was conducted in accordance with:
- Non-Clinical Information for Femoral Stem Prostheses, dated September 2007
- Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked" Modular Implant Components, dated May 1995
Tests Performed: Environmental corrosion fatigue, post-fatigue pull-off, fatigue strength testing, and range of motion evaluation.
Substantial Equivalence: The primary basis for clearance is demonstrating substantial equivalence to the predicate device (MDF Revision Hip Stem, K081124) by showing similarities in materials (Ti-6AL-4V), intended/indications for use, sterilization, overall design philosophy, and performance, despite minor modifications (e.g., size offerings, absence of modular sleeves). The "Conclusion" explicitly states this.
Clinical Data: No clinical data was required or used to support the safety and effectiveness of this device.

Summary

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APR 1 9 2012

Smith & Nephew, Inc. Summary of Safety and Effectiveness Modular Proximally Fluted Hip Stem

Date of Summary: 4/12/2012

Contact Person and Address Natalie P. Williams Regulatory Affairs Specialist Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 (901) 399-5161

Name of Device: Smith & Nephew Modular Proximally Fluted Hip Stem Common Name: Femoral Hip Prosthesis

Device Classification Name and Reference: 21 CFR 888.3353 Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Device Class: II

Panel Code: Orthopaedics/87 MEH, LZO

Device Description

Indications for Use

Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.

Performance Data

Performance testing has been conducted for the subject devices in accordance with the following guidance documents:

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Non-Clinical Information for Femoral Stem Prostheses, dated September 2007
Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked" Modular Implant Components, dated May 1995
Environmental corrosion fatigue, post-fatigue pull-off, and fatigue strength testing were performed. The range of motion of the subject device was also evaluated. A review of the testing and analysis has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.

Substantial Equivalence Information

The materials, intended use, indications for use, sterilization, and overall design of the Smith & Nephew Modular Proximally Fluted Hip Stems are substantially equivalent to the MDF Revision Hip Stems cleared in premarket notification K081124. Giving consideration to the device modifications described in the Device Description section, no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate devices. A comparison of the Modular Proximally Fluted Hip Stem to the predicate device is provided in Table 1 below.

Design Features	Device Names
	Subject Smith & NephewModular ProximallyFluted Hip Stem	Smith & Nephew MDFRevision Hip Stem(K081124)
Similar Indications forUse/Intended Use	Yes	Yes
Size Offering	12-27	11-25
Stem Lengths (mm)	240mm; 300mm	240mm; 300mm
Stem Material	Ti-6AL-4V	Ti-6AL-4V
Fluted Tapered Stem	Yes	Yes
Modular Sleeves	No	Yes
Neck Taper	12/14	12/14
Cobalt ChromeModular Necks	Yes	Yes

Table 1: Comparison of the Modular Proximally Fluted Hip Stems to Predicate Device

Conclusion

This Abbreviated 510(k) Premarket Notification is being submitted to request clearance for the Modular Proximally Fluted Hip Stems. Based on the similarities to the predicate devices are substantially equivalent to femoral stem components currently marketed under K081124.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

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

Smith & Nephew, Incorporated % Ms. Natalie P. Williams Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

APR 1 9 2012

Re: K113789

Trade/Device Name: Smith & Nephew Modular Proximally Fluted Hip 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: MEH, LZO Dated: April 12, 2012 Received: April 13, 2012

Dear Ms. Williams:

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 for assossion 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). and coometre i rove, roo the the device, subject to the general controls provisions of the Act. The I ou may a 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 adulteration. Ticasonote. ODFET as tevice 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 If your device is elassified (boo are 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 I lease be devices and i 12 mination that your device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must or any I coolar statuted and regainments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CITY an 007), lucemig (21 OFF 803); good manufacturing practice requirements as set

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Page 2 - Ms. Natalie P. Williams

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 yours,

Mark A. Millherson

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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Indications for Use

K1137

510(k) Number (if known):

Device Name: Smith & Nephew Modular Proximally Fluted Hip Stem

Indications for Use:

Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart Cl

(Please DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number

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.