Who is the manufacturer of CoreHip® System?

Aesculap Implants Systems, LLC filed the 510(k) submission for CoreHip® System (K172235).

What is the FDA product code for CoreHip® System?

LZO. It is classified under 21 CFR 888.3353 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for CoreHip® System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CoreHip® System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CoreHip® System

Q: What are the predicate devices for CoreHip® System?

Excia® Total Hip System (K150062).

K172235 · Aesculap Implants Systems, LLC · LZO · Mar 28, 2018 · Orthopedic

Device Facts

Record ID	K172235
Device Name	CoreHip® System
Applicant	Aesculap Implants Systems, LLC
Product Code	LZO · Orthopedic
Decision Date	Mar 28, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3353
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

CoreHip® System is a femoral hip prosthesis for total hip arthroplasty; replaces hip joint. Available in two configurations: cemented (CoCrMo) and uncemented/pressfit (Ti with Plasmapore® coating). Includes variants for varus, neutral, valgus, and dysplasia morphologies. Used by orthopedic surgeons in clinical settings. Device provides structural support for hip joint; restores mobility; alleviates pain. Surgeon selects appropriate stem size and geometry based on patient anatomy; implants device during surgery. Benefits include improved joint function and quality of life for patients with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only. Endurance properties of stem, head, and neck evaluated per ASTM F2068-15, ISO 7206-4, and ISO 7206-6. Range of Motion (ROM) analysis performed per ISO 21535. Pyrogen testing (LAL) met limits of 20 E.U./device.

Technological Characteristics

Materials: CoCrMo (cemented), Ti with Plasmapore® plasma spray coating (uncemented). Design: Femoral stems with 12/14 external taper. Sizes 1-11. Fixation: Cemented or uncemented (pressfit). Sterilization: Sterile, single-use. No software or active energy source.

Indications for Use

Indicated for patients with severe hip pain/disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, nonunion of femoral fractures, congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, disability from previous fusion, or acute femoral neck fractures.

Regulatory Classification

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.

Predicate Devices

Excia® Total Hip System (K150062)

Reference Devices

Zimmer Fitmore Knee System (Porolock MIS Stem) (K071723)

Related Devices

K210678 — implaFit® hip stems · Implantcast GmbH · Aug 17, 2022
K060437 — EXCIA TOTAL HIP SYSTEM WITH U-CAP · Aesculap, Inc. · Mar 22, 2006
K021346 — STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX · Wrightmedicaltechnologyinc · Jul 2, 2002
K964218 — PERFECTA PLASMA SPRAY HIP STEM · Wrightmedicaltechnologyinc · Jan 8, 1997
K161840 — LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated · Waldemar Link GmbH & Co. KG · Mar 16, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written in a sans-serif font. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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 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. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 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, LLC 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311 | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT: | Paul Amudala 610-984-9303 (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-constrained cemented or nonporous uncemented prosthesis 888.3360-Hip joint femoral (hemi-hip) metal polymer cemented or uncemented prosthesis 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. | | PRODUCT CODE(S): | LZO | | SUBSEQUENT PRODUCT 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 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 {4}------------------------------------------------ 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® Total System (Primary Predicate) | Fitmore Hip System (Reference Predicate) | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | K# | K172235 | K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344) | K071723 | | | | Manufacturer | Aesculap Implant Systems | Aesculap Implant Systems | 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® Total System (Primary Predicate) | Fitmore Hip System (Reference Predicate) | | | | | 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. | 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 Excia Hip System is available with two(2) femoral stems. One is manufactured from CoCrMo and intended for cemented fixation. The other femoral stem is for | arthroplasty and is indicated for the following conditions: Patient conditions of non- inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; Those patients with failed previous surgery where pain, deformity, or dysfunction persists; Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured This includes severely crippled patients with multiple joint involvement , for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. The stem is for cementless use only. | | | | | | CoreHip System (Principle) | Excia® Total System (Primary Predicate) | Fitmore Hip System (Reference Predicate) | | | | Materials | 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. | cementless fixation and is manufactured from Ti with Plasmapore or Without μCap®. The Excia® Hip 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® with or without μCaP® and is intended for cementless fixation. | This femoral stem is available with one (1) type of femoral fixation. It is manufactured from Ti with Ti plasma spray and is intended for uncemented use only. | | | | | Bone Apposition | CoreHip uncemented (pressfit) Primary and CoreHip uncemented (pressfit) Extended Stems incorporate Plasmapore® a Ti-plasma spray coating proximally and rough-blasted surface distally. CoreHip cemented Primary incorporates the use of cement for fixation. | The Excia® Hip System cementless stems incorporate Plasmapore® a Ti -plasma spray coating proximally and smooth surface distally. The Excia® Hip System cemented stems incorporate the use of cement for fixation. | This femoral stem incorporates a Ti-Plasma spray coating proximally and rough-blasted surface distally. | | | | | 12/14 Taper | 12/14 Taper Only available | 8/10 and 12/14 Tapers available | 12/14 Taper Only available | | | | Stem Offset | Dysplasia: 142° Neck Angle Valgus: 142° Neck Angle | 6mm from the lesser neck angle | Family A: 140° | | | | Standard/Neutral Neck Angle | Standard/Neutral: 132° Neck Angle | 135° | Family B: 137° Family B ext: 129° | | | | Lateral Neck Angle | Varus: 122° Neck Angle Each provides a 7.5mm offset from the lesser neck angle | 128° | Family C: 127° | | | | | CoreHip System (Principle) | Excia® Total System (Primary Predicate) | Fitmore Hip System (Reference Predicate) | | | | Sterile, Single Use | Sterile, Single Use | Sterile, Single Use | Sterile, Single Use | | | | Stem Sizes | CoreHip uncemented (pressfit) Primary : Sizes 1-11 (except size 1 dysplasia) CoreHip uncemented (pressfit) Extended: Sizes 1-11 CoreHip cemented Primary : Sizes 1-11 | Excia 8/10 Trunnion cementless: Sizes 8-18 Excia 8/10 Trunnion cemented: Sizes 9-18 Excia 12/14 Trunnion cementless: Sizes 8-18 Excia 12/14 Trunnion cemented: Sizes 9-19 Excia T 12/14 Trunnion cementless: Sizes 8-20 Excia T 12/14 Trunnion cemented: Sizes 10-20 (even sizes only) | Family A: Sizes 2-8 Family B: Sizes 1-7 Family B ext: Sizes 1-7 Family C: Sizes 1-7 | | Centralizer | Distal Centralizer Sizes 1-11…