· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur

· Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
· Patients suffering from disability due to previous fusion
· Patients with acute femoral neck fractures

The CoreHip® System is available with two (2) types of femoral stem is manufactured from CoCrMo and is intended for cemented fixation and the other femoral stem is manufactured from Ti with Plasmapore® and is intended for uncemented (pressfit) fixation.

Device Description

The CoreHip System includes cemented and uncemented (pressfit) stems. The CoreHip uncemented (pressfit) Stem is offered as CoreHip uncemented (pressfit) Primary and CoreHip uncemented (pressfit) Extended which are manufactured from Ti with a Ti plasma spray coating (Plasmapore®) proximally and rough-blasted distally. The Cemented Stem is offered as CoreHip Cemented Primary stem which is manufactured from CoCrMo. The CoreHip System includes stem variants of varus, neutral, valgus and dysplasia is offered in CoreHip uncemented (pressfit) Primary only), which have different medial curves in order to address different patient morphologies. The femoral stems will be offered in a 12/14 external taper in stem sizes 1 to 11 for the uncemented (pressfit) design (primary (except size 1 dysplasia) and extended) and sizes 1-11 for the cemented design.

AI/ML Overview

This document is a 510(k) premarket notification for a hip implant system, not an AI/ML device study. Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/ML device is not present in this document.

The document discusses the substantial equivalence of the CoreHip® System to predicate devices. It focuses on the safety and effectiveness of the traditional medical device (hip implant) through:

Indications for Use: Defining for which patient conditions the device is intended.
Technological Characteristics Comparison: Comparing materials, fixation types, stem sizes, and geometry with predicate devices.
Performance Data: This section details non-clinical performance testing, primarily mechanical endurance testing, to demonstrate the device's substantial equivalence to previously cleared devices.

Here's what can be extracted regarding performance, even though it's not related to AI:

Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with specific numerical targets and reported device performance values in the way you might expect for a diagnostic or AI device. Instead, the performance claims are based on compliance with established standards and comparison to predicate devices.

Key Performance Statements:

"Endurance properties of the CoreHip cemented and uncemented (pressfit) stem, head and neck were evaluated in accordance to Guidance for Industry and FDA Staff Non-clinical Information for Femoral Prostheses, September 17, 2007; ASTM F2068-15; ISO 7206-4 and ISO 7206-6."
"Additional Femoral head/Taper testing was completed."
"Range of Motion (ROM) analysis to satisfy the requirements of ISO 21535 was completed."
"Testing demonstrated that the subject device is substantially equivalent to the Primary and reference predicate devices."
"PYROGEN TESTING: LAL testing was completed and met the pyrogen limit of 20 E.U./device."

Essentially, the acceptance criteria are implicitly met by:

Adherence to recognized industry standards: ASTM F2068-15, ISO 7206-4, ISO 7206-6, and ISO 21535.
Demonstrating substantial equivalence to legally marketed predicate devices in terms of performance and safety.
Meeting specific pyrogenicity limits: LAL testing confirmed meeting the pyrogen limit of 20 E.U./device.

As this is a 510(k) for a physical implant, specific "reported device performance" in terms of accuracy, sensitivity, or specificity (relevant to AI/ML) is not applicable. The performance is assessed on mechanical integrity, fatigue life, and biocompatibility, which are demonstrated through testing against relevant standards.

The remaining points of your request are not applicable to the provided document as it describes a non-AI medical device submission.

Summary

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Aesculap Implants Systems, LLC Paul Amudala Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

March 28, 2018

Re: K172235

Trade/Device Name: CoreHip® 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, LWJ, KWY Dated: February 19, 2018 Received: February 20, 2018

Dear Paul Amudala:

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 (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.

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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 medical devices and radiation-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,

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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Indications for Use

510(k) Number (if known) K172235

Device Name

CoreHip® System

Indications for Use (Describe)

The CoreHip® System is intended to replace a hip joint. The device is intended for:

· Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
· Patients suffering from disability due to previous fusion
· Patients with acute femoral neck fractures

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K172235 Page 1 of 5

B. 510(k) SUMMARY (as required by 21 CFR 807.92)

CoreHip® System

Mar 26, 2018

COMPANY:	Aesculap Implant Systems, LLC3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311
CONTACT:	Paul Amudala610-984-9303 (phone)610-791-6882 (fax)paul.amudala@aesculapimplants.com
TRADE NAME:	CoreHip® System
COMMON NAME:	Femoral Hip Stem
REGULATION NUMBER:	888.3353-Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis888.3360-Hip joint femoral (hemi-hip) metal polymer cemented oruncemented prosthesis888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis.
PRODUCT CODE(S):	LZO
SUBSEQUENTPRODUCT CODE(S):	LWJ; KWY
REVIEW PANEL:	Orthopedics

SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, LLC (AIS) believes that CoreHip® System is substantially equivalent to the Primary Predicate AIS Excia® Total Hip System (K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344)) and Reference Predicate Zimmer Fitmore Knee System (Porolock MIS Stem) (K071723).

DEVICE DESCRIPTION

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K172235 Page 2 of 5

morphologies. The femoral stems will be offered in a 12/14 external taper in stem sizes 1 to 11 for the uncemented (pressfit) design (primary (except size 1 dysplasia) and extended) and sizes 1-11 for the cemented design.

PURPOSE FOR PREMARKET NOTIFICATION

The purpose of this premarket notification is to gain clearance of CoreHip cemented and uncemented (pressfit) femoral System.

INDICATIONS FOR USE

The CoreHip® System is intended to replace a hip joint. The device is intended for:

· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur
· Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
· Patients suffering from disability due to previous fusion
Patients with acute femoral neck fractures

The CoreHip® System is available with two (2) types of femoral stem fixation. One stem is manufactured from CoCrMo and is intended for cemented fixation and the other femoral stem is manufactured from Ti with Plasmapore® and is intended for uncemented (pressfit) fixation.

TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s))

The addition of the CoreHip System to the AIS Hip portfolio is substantially equivalent to the Primary Predicate Excia® Total Hip System and the Reference Predicate Fitmore Hip System. The subject device has the same technological characteristics through comparison of the currently marketed stem, intended use, indications for use, materials of construction, manufacturing process, and range of sizes offered.

	CoreHip System (Principle)	Excia® TotalSystem (PrimaryPredicate)	Fitmore Hip System(Reference Predicate)
K#	K172235	K150062(includingK140915,K092143,K090299,K081973,K082991,K062684,K061699,K061344,K060918,K060437, andK042344)	K071723
Manufacturer	Aesculap Implant Systems	Aesculap ImplantSystems	ZimmerBiomet.
Indications	The CoreHip System is	The Excia® Hip	Zimmer Fitmore
	intended to replace a hip joint.	System is	(Porolock MIS Stem)
	The device is intended for:	intended to
	• Patients suffering from severe	replace the hip	This femoral stem is for
	hip pain and disability due to	joint.	total or hemi-hip
CoreHip System (Principle)	Excia® TotalSystem (PrimaryPredicate)	Fitmore Hip System(Reference Predicate)
rheumatoid arthritis,osteoarthritis, traumaticarthritis, polyarthritis,collagen disorders, avascularnecrosis of the femoral headand nonunion of previousfractures of the femur• Patients with congenital hipdysplasia, protrusionacetabuli, or slipped capitalfemoral epiphysis• Patients suffering fromdisability due to previousfusion• Patients with acute femoralneck fracturesThe CoreHip system isavailable with two (2) types offemoral stem fixation. Onestem is manufactured fromCoCrMo and is intended forcemented fixation and the otherfemoral stem is manufacturedfrom Ti with Plasmapore® andis intended for uncemented(pressfit) fixation.	The device isintended for:• Patientssufferingfrom severehip pain anddisability duetorheumatoidarthritis,osteoarthritis,traumaticarthritis,polyarthritis,collagendisorders,avascularnecrosis ofthe femoralhead andnonunion ofpreviousfractures ofthe femur• Patients withcongenitalhipdysplasia,protrusionacetabuli, orslippedcapitalfemoralepiphysis• Patientssufferingfromdisability dueto previousfusion• Patients withacute femoralneckfracturesThe Excia HipSystem isavailable withtwo(2) femoralstems. One ismanufacturedfrom CoCrMoand intended forcementedfixation. Theother femoralstem is for	arthroplasty and isindicated for thefollowing conditions:Patient conditions of non-inflammatorydegenerative joint disease(NIDJD), e.g., avascularnecrosis, osteoarthritis,and inflammatorydegenerative joint disease(IJD), e.g., rheumatoidarthritis;Those patients with failedprevious surgery wherepain, deformity, ordysfunction persists;Total hip replacementsmay be considered foryounger patients if anyunequivocal indicationoutweighs the risksassociated with the age ofthe patient and modifieddemands regardingactivity and hip jointloading are assured Thisincludes severelycrippled patients withmultiple jointinvolvement , for whoman immediate need of hipmobility leads to anexpectation of significantimprovement in thequality of their lives.The stem is forcementless use only.
	CoreHip System (Principle)	Excia® Total System (Primary Predicate)	Fitmore Hip System (Reference Predicate)
Materials	The CoreHip System isavailable with two (2) types offemoral stem fixation. Onestem is manufactured fromCoCrMo and is intended forcemented fixation and the otherfemoral stem is manufacturedfrom Ti with Plasmapore® andis intended for uncemented(pressfit) fixation.	cementlessfixation and ismanufacturedfrom Ti withPlasmapore orWithout μCap®.The Excia® HipSystem isavailable withtwo (2) types offemoral stemfixation. Onestem ismanufacturedfrom CoCrMoand is intendedfor cementedfixation and theother femoralstem ismanufacturedfrom Ti withPlasmapore®with or withoutμCaP® and isintended forcementlessfixation.	This femoral stem isavailable with one (1)type of femoral fixation.It is manufactured fromTi with Ti plasma sprayand is intended foruncemented use only.
	Bone Apposition	CoreHip uncemented (pressfit)Primary and CoreHipuncemented (pressfit) ExtendedStems incorporate Plasmapore®a Ti-plasma spray coatingproximally and rough-blastedsurface distally.CoreHip cemented Primaryincorporates the use of cementfor fixation.	The Excia® HipSystemcementless stemsincorporatePlasmapore® a Ti-plasma spraycoatingproximally andsmooth surfacedistally.The Excia® HipSystem cementedstems incorporatethe use of cementfor fixation.	This femoral stemincorporates a Ti-Plasmaspray coating proximallyand rough-blasted surfacedistally.
		12/14 Taper	12/14 Taper Only available	8/10 and 12/14Tapers available	12/14 Taper Onlyavailable
		Stem Offset	Dysplasia: 142° Neck AngleValgus: 142° Neck Angle	6mm from thelesser neck angle	Family A: 140°
		Standard/NeutralNeck Angle	Standard/Neutral: 132° NeckAngle	135°	Family B: 137°Family B ext: 129°
		Lateral NeckAngle	Varus: 122° Neck AngleEach provides a 7.5mm offsetfrom the lesser neck angle	128°	Family C: 127°
			CoreHip System (Principle)	Excia® Total System (PrimaryPredicate)	Fitmore Hip System(Reference Predicate)
		Sterile, SingleUse	Sterile, Single Use	Sterile, SingleUse	Sterile, Single Use
		Stem Sizes	CoreHip uncemented (pressfit)Primary : Sizes 1-11 (exceptsize 1 dysplasia)CoreHip uncemented (pressfit)Extended: Sizes 1-11CoreHip cemented Primary :Sizes 1-11	Excia 8/10Trunnioncementless: Sizes8-18Excia 8/10Trunnioncemented: Sizes9-18Excia 12/14Trunnioncementless: Sizes8-18Excia 12/14Trunnioncemented: Sizes9-19Excia T 12/14Trunnioncementless: Sizes8-20Excia T 12/14Trunnioncemented: Sizes10-20 (even sizesonly)	Family A: Sizes 2-8Family B: Sizes 1-7Family B ext: Sizes 1-7Family C: Sizes 1-7
Centralizer	Distal Centralizer Sizes 1-11	Distal Centralizer	N/A

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PERFORMANCE DATA

Endurance properties of the CoreHip cemented and uncemented (pressfit) stem, head and neck were evaluated in accordance to Guidance for Industry and FDA Staff Non-clinical Information for Femoral Prostheses, September 17, 2007; ASTM F2068-15; ISO 7206-4 and ISO 7206-6. Additional Femoral head/Taper testing was completed. Range of Motion (ROM) analysis to satisfy the requirements of ISO 21535 was completed. Testing demonstrated that the subject device is substantially equivalent to the Primary and reference predicate devices.

PYROGEN TESTING: LAL testing was completed and met the pyrogen limit of 20 E.U./device.

CONCLUSION: Based on the performance tests completed, AIS believes that CoreHip System is substantially equivalent to the Primary Predicate Excia® Total Hip System and Reference Predicate Fitmore Hip System.

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.