A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Hemi hip replacement is indicated in the following conditions:

Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated fixation.
Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
Avascular necrosis of the femoral head.
Non-union of femoral neck fractures.
Certain high subcapital and femoral neck fractures in the elderly.
Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

The SUMMIT POROCOAT Porous, SUMMIT DuoFix Porous, and SUMMIT Basic Press Fit stems are indicated for uncemented use only.
The SUMMIT Cemented and SUMMIT Basic Cemented stems are indicated for cemented use only.

Device Description

The Summit Hip System is series of tapered femoral hip stems which may be used in either total or hemi-hip arthroplasty procedures in conjunction with DePuy hip arthroplasty devices.
The Summit Porous Hip Prosthesis is a series of collarless, titanium, tapered, press fit femoral stems The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only.
The Summit DuoFix Porous Hip Prosthesis is a series of collarless, titanium alloy, tapered, press-fit femoral stems. The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem with a thin layer of hydroxyapatite (HA) coating. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only.
The Summit Cemented Hip Prosthesis is series a flanged, collared tapered Cobalt-Chromium femoral stems with a smooth finish. There are seven proportional body sizes with a standard offset, and six proportional body sizes with a high offset. Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal. These stems are intended for cemented use only.
The Summit Basic Cemented Hip Prosthesis is a series of flanged, collared, tapered Cobalt-Chromium-Molybdenum femoral stems with a smooth surface finish. There are seven total sizes with a constant offset. Only six of the seven sizes are available in the high offset option. A distal PMMA centralizer helps assure that the stem is centered in the femoral canal. These stems are intended for cemented use only.
The Summit Basic Press Fit Hip Prosthesis is a series of collared, tapered Titanium femoral stem with a grit-blasted finish. There are seven sizes with a constant offset and a distal centralizer to assure that the stem is centered in the femoral canal. These stems are intended for uncemented use only.

AI/ML Overview

This is a 510(k) summary for the Summit Hip System, which is a medical device. This document does not describe acceptance criteria for an AI/ML device, nor does it contain information about a study proving such a device meets acceptance criteria. Instead, it describes non-clinical tests conducted to demonstrate substantial equivalence of the Summit Hip System to predicate devices.

Therefore, I cannot answer your request based on the provided text as it does not contain the information you are looking for.

Summary

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Depuy Orthopaedics, Inc. Daniel J. Williman Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46582

April 26, 2018

Re: K170339

Trade/Device Name: Summit 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: LZO, JDI, LWJ, LPH, MEH, KWY, KWL, LZY Dated: March 28, 2018 Received: March 29, 2018

Dear Daniel J. Williman:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K170339

Device Name Summit Hip System

Indications for Use (Describe)

Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface

replacement arthroplasty, or total hip replacement.

Certain cases of ankylosis.

Hemi hip replacement is indicated in the following conditions:

Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated fixation.
Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
Avascular necrosis of the femoral head.
Non-union of femoral neck fractures.
Certain high subcapital and femoral neck fractures in the elderly.
Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

The SUMMIT POROCOAT Porous, SUMMIT DuoFix Porous, and SUMMIT Basic Press Fit stems are indicated for uncemented use only.

The SUMMIT Cemented and SUMMIT Basic Cemented stems are indicated for cemented use only.

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

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Submitter Information
Name	DePuy Orthopaedics
Address	700 Orthopedic DriveWarsaw, IN 46582
Phone number	574-372-7745
Fax number	574-371-4987
Establishment RegistrationNumber	1818910
Name of contact person	Daniel J. Williman
Date prepared	March 28, 2017
Name of device
Trade or proprietary name	Summit Hip System
Common or usual name	Hip Joint Replacement Prosthesis
Classification name	Hip joint metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis;
Class	II
Classification panel	87 Orthopedic and Rehabilitation Devices
Regulation	21 CFR 888.3353, 888.3350, 888.3358, 888.3360, and 888.3390
Product Codes	LZO, JDI, LWJ, LPH, MEH, KWY, LZY, KWL
Predicate Devices	K001991 Titan Porocoat Hip Prosthesis
	K011489 Summit Duofix Hip Prosthesis
	K013352 Summit Cemented Hip Prosthesis
	K023453 DePuy Cemented FX Cemented Hip Prosthesis
	K030122 DePuy Summit Basic Press Fit Hip Prosthesis
	K150862 DePuy Actis DuoFix Hip Prosthesis
	K123991 DePuy Corail AMT Hip Prosthesis
Reason for 510(k) Submission	The purpose of this submission is to append to the existingindication for use statement to include hemi-hip replacement for theSummit Hip System.
Device description	The Summit Hip System is series of tapered femoral hip stemswhich may be used in either total or hemi-hip arthroplastyprocedures in conjunction with DePuy hip arthroplasty devices.The Summit Porous Hip Prosthesis is a series of collarless, titanium,tapered, press fit femoral stems The hip stem is manufactured from
	titanium alloy (Ti-6Al-4V) and has a sintered commercially puretitanium bead porous coating (Porocoat) applied to the stem. Thereare 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm(Size 10) with each body size having two offset options. Thesestems are intended for uncemented use only.
	The Summit DuoFix Porous Hip Prosthesis is a series of collarless,titanium alloy, tapered, press-fit femoral stems. The hip stem ismanufactured from titanium alloy (Ti-6Al-4V) and has a sinteredcommercially pure titanium bead porous coating (Porocoat) appliedto the stem with a thin layer of hydroxyapatite (HA) coating. Thereare 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm(Size 10) with each body size having two offset options. Thesestems are intended for uncemented use only.
	The Summit Cemented Hip Prosthesis is series a flanged, collaredtapered Cobalt-Chromium femoral stems with a smooth finish.There are seven proportional body sizes with a standard offset, andsix proportional body sizes with a high offset. Distal and proximalPMMA centralizers help assure the stem is centered in the femoralcanal. These stems are intended for cemented use only.
	The Summit Basic Cemented Hip Prosthesis is a series of flanged,collared, tapered Cobalt-Chromium-Molybdenum femoral stemswith a smooth surface finish. There are seven total sizes with aconstant offset. Only six of the seven sizes are available in the highoffset option. A distal PMMA centralizer helps assure that the stemis centered in the femoral canal. These stems are intended forcemented use only.
	The Summit Basic Press Fit Hip Prosthesis is a series of collared,tapered Titanium femoral stem with a grit-blasted finish. There areseven sizes with a constant offset and a distal centralizer to assurethat the stem is centered in the femoral canal. These stems areintended for uncemented use only.
Intended use of the device	Total and hemi-hip arthroplasty is intended to provide increasedpatient mobility and reduce pain by replacing the damaged hip jointarticulation in patients where there is evidence of sufficient soundbone to seat and support the components.
	Total or hemi-hip arthroplasty may be considered for youngerpatients if, in the opinion of the surgeon, an unequivocal indicationfor total or hemi-hip replacement outweighs the risks associatedwith the age of the patient and if limited demands regarding activityand hip joint loading can be assured. This includes severely crippledpatients with multiple joint involvement for whom a gain in hipmobility may lead to an expectation of significant improvement inthe quality of their lives.
Indications for use	Total hip replacement is indicated in the following conditions:1. A severely painful and/or disabled joint from osteoarthritis,traumatic arthritis, rheumatoid arthritis, or congenital hipdislocation.
dysplasia.2. Avascular necrosis of the femoral head.3. Acute traumatic fracture of the femoral head or neck.4. Failed previous hip surgery including joint reconstruction, internalfixation, arthrodesis, hemiarthroplasty, surface replacementarthroplasty, or total hip replacement.5. Certain cases of ankylosis.Hemi hip replacement is indicated in the following conditions:1. Acute fracture of the femoral head or neck that cannot beappropriately reduced and treated with internal fixation.2. Fracture dislocation of the hip that cannot be appropriately reducedand treated with internal fixation.3. Avascular necrosis of the femoral head.4. Non-union of femoral neck fractures.5. Certain high subcapital and femoral neck fractures in the elderly.6. Degenerative arthritis involving only the femoral head in whichthe acetabulum does not require replacement.7. Pathology involving only the femoral head/neck and/or proximalfemur that can be adequately treated by hemi-hip arthroplasty.The SUMMIT POROCOAT Porous, SUMMIT DuoFixPorous, and SUMMIT Basic Press Fit stems are indicated foruncemented use only. The SUMMIT Cemented and SUMMITBasic Cemented stems are indicated for cemented use only.
SUBSTANTIAL EQUIVALENCE INFORMATION
The subject and predicate Summit stem devices are identical in design, materials, and coatings. Non-clinical testing demonstrated performance equivalence between the subject and predicate devices.
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE
To support a determination of substantial equivalence, non-clinical testing/evaluations were conducted.
The following studies were provided:● Hip Head Center Analysis – Demonstrated that Summit stem hemi-arthroplasty constructs do notintroduce new fatigue strength risks when compared to Summit stem total hip arthroplastyconstructs.● Corrosion Analyses - Demonstrated that Summit stem hemi-arthroplasty constructs pose nogreater risk for corrosion when compared to the predicate device Summit and/or Actis stems.● Range of Motion (ROM) Analysis – Concluded that the Summit stem hemi-arthroplastyconstructs have ROM equivalent to that of the predicate device Actis stem hemi-arthroplastyconstructs.● Pyrogenicity Testing – Concluded that the subject devices meet the required endotoxin limits
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE AND/OR OF CLINICAL INFORMATION
No Clinical tests were required to support this premarket 510(k) submission.

510(k) Summary (As required by 21 CFR 807.92 and 21 CFR 807.93)

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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.