CoreHip® System
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 |
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.
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)
Submission Summary (Full Text)
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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 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)
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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, LLC<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 3005673311 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Paul Amudala<br>610-984-9303 (phone)<br>610-791-6882 (fax)<br>paul.amudala@aesculapimplants.com |
| TRADE NAME: | CoreHip® System |
| COMMON NAME: | Femoral Hip Stem |
| REGULATION NUMBER: | 888.3353-Hip joint metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented prosthesis<br>888.3360-Hip joint femoral (hemi-hip) metal polymer cemented or<br>uncemented prosthesis<br>888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or<br>uncemented prosthesis. |
| PRODUCT CODE(S): | LZO |
| SUBSEQUENT<br>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
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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® Total<br>System (Primary<br>Predicate) | Fitmore Hip System<br>(Reference Predicate) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| K# | K172235 | K150062<br>(including<br>K140915,<br>K092143,<br>K090299,<br>K081973,<br>K082991,<br>K062684,<br>K061699,<br>K061344,<br>K060918,<br>K060437, and<br>K042344) | K071723 | | |
| Manufacturer | Aesculap Implant Systems | Aesculap Implant<br>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<br>System (Primary<br>Predicate) | Fitmore Hip System<br>(Reference Predicate) | | | |
| rheumatoid arthritis,<br>osteoarthritis, traumatic<br>arthritis, polyarthritis,<br>collagen disorders, avascular<br>necrosis of the femoral head<br>and nonunion of previous<br>fractures of the femur<br>• Patients with congenital hip<br>dysplasia, protrusion<br>acetabuli, or slipped capital<br>femoral epiphysis<br>• Patients suffering from<br>disability due to previous<br>fusion<br>• Patients with acute femoral<br>neck fractures<br>The CoreHip system is<br>available with two (2) types of<br>femoral stem fixation. One<br>stem is manufactured from<br>CoCrMo and is intended for<br>cemented fixation and the other<br>femoral stem is manufactured<br>from Ti with Plasmapore® and<br>is intended for uncemented<br>(pressfit) fixation. | The device is<br>intended for:<br>• Patients<br>suffering<br>from severe<br>hip pain and<br>disability due<br>to<br>rheumatoid<br>arthritis,<br>osteoarthritis,<br>traumatic<br>arthritis,<br>polyarthritis,<br>collagen<br>disorders,<br>avascular<br>necrosis of<br>the femoral<br>head and<br>nonunion of<br>previous<br>fractures of<br>the femur<br>• Patients with<br>congenital<br>hip<br>dysplasia,<br>protrusion<br>acetabuli, or<br>slipped<br>capital<br>femoral<br>epiphysis<br>• Patients<br>suffering<br>from<br>disability due<br>to previous<br>fusion<br>• Patients with<br>acute femoral<br>neck<br>fractures<br>The Excia Hip<br>System is<br>available with<br>two(2) femoral<br>stems. One is<br>manufactured<br>from CoCrMo<br>and intended for<br>cemented<br>fixation. The<br>other femoral<br>stem is for | arthroplasty and is<br>indicated for the<br>following conditions:<br>Patient conditions of non-<br>inflammatory<br>degenerative joint disease<br>(NIDJD), e.g., avascular<br>necrosis, osteoarthritis,<br>and inflammatory<br>degenerative joint disease<br>(IJD), e.g., rheumatoid<br>arthritis;<br>Those patients with failed<br>previous surgery where<br>pain, deformity, or<br>dysfunction persists;<br>Total hip replacements<br>may be considered for<br>younger patients if any<br>unequivocal indication<br>outweighs the risks<br>associated with the age of<br>the patient and modified<br>demands regarding<br>activity and hip joint<br>loading are assured This<br>includes severely<br>crippled patients with<br>multiple joint<br>involvement , for whom<br>an immediate need of hip<br>mobility leads to an<br>expectation of significant<br>improvement in the<br>quality of their lives.<br>The stem is for<br>cementless use only. | | | |
| | CoreHip System (Principle) | Excia® Total System (Primary Predicate) | Fitmore Hip System (Reference Predicate) | | |
| Materials | The CoreHip System is<br>available with two (2) types of<br>femoral stem fixation. One<br>stem is manufactured from<br>CoCrMo and is intended for<br>cemented fixation and the other<br>femoral stem is manufactured<br>from Ti with Plasmapore® and<br>is intended for uncemented<br>(pressfit) fixation. | cementless<br>fixation and is<br>manufactured<br>from Ti with<br>Plasmapore or<br>Without μCap®.<br>The Excia® Hip<br>System is<br>available with<br>two (2) types of<br>femoral stem<br>fixation. One<br>stem is<br>manufactured<br>from CoCrMo<br>and is intended<br>for cemented<br>fixation and the<br>other femoral<br>stem is<br>manufactured<br>from Ti with<br>Plasmapore®<br>with or without<br>μCaP® and is<br>intended for<br>cementless<br>fixation. | This femoral stem is<br>available with one (1)<br>type of femoral fixation.<br>It is manufactured from<br>Ti with Ti plasma spray<br>and is intended for<br>uncemented use only. | | |
| | Bone Apposition | CoreHip uncemented (pressfit)<br>Primary and CoreHip<br>uncemented (pressfit) Extended<br>Stems incorporate Plasmapore®<br>a Ti-plasma spray coating<br>proximally and rough-blasted<br>surface distally.<br><br>CoreHip cemented Primary<br>incorporates the use of cement<br>for fixation. | The Excia® Hip<br>System<br>cementless stems<br>incorporate<br>Plasmapore® a Ti<br>-plasma spray<br>coating<br>proximally and<br>smooth surface<br>distally.<br><br>The Excia® Hip<br>System cemented<br>stems incorporate<br>the use of cement<br>for fixation. | This femoral stem<br>incorporates a Ti-Plasma<br>spray coating proximally<br>and rough-blasted surface<br>distally. | |
| | | 12/14 Taper | 12/14 Taper Only available | 8/10 and 12/14<br>Tapers available | 12/14 Taper Only<br>available |
| | | Stem Offset | Dysplasia: 142° Neck Angle<br>Valgus: 142° Neck Angle | 6mm from the<br>lesser neck angle | Family A: 140° |
| | | Standard/Neutral<br>Neck Angle | Standard/Neutral: 132° Neck<br>Angle | 135° | Family B: 137°<br>Family B ext: 129° |
| | | Lateral Neck<br>Angle | Varus: 122° Neck Angle<br><br>Each provides a 7.5mm offset<br>from the lesser neck angle | 128° | Family C: 127° |
| | | | CoreHip System (Principle) | Excia® Total System (Primary<br>Predicate) | Fitmore Hip System<br>(Reference Predicate) |
| | | Sterile, Single<br>Use | Sterile, Single Use | Sterile, Single<br>Use | Sterile, Single Use |
| | | Stem Sizes | CoreHip uncemented (pressfit)<br>Primary : Sizes 1-11 (except<br>size 1 dysplasia)<br>CoreHip uncemented (pressfit)<br>Extended: Sizes 1-11<br>CoreHip cemented Primary :<br>Sizes 1-11 | Excia 8/10<br>Trunnion<br>cementless: Sizes<br>8-18<br>Excia 8/10<br>Trunnion<br>cemented: Sizes<br>9-18<br>Excia 12/14<br>Trunnion<br>cementless: Sizes<br>8-18<br>Excia 12/14<br>Trunnion<br>cemented: Sizes<br>9-19<br>Excia T 12/14<br>Trunnion<br>cementless: Sizes<br>8-20<br>Excia T 12/14<br>Trunnion<br>cemented: Sizes<br>10-20 (even sizes<br>only) | Family A: Sizes 2-8<br>Family B: Sizes 1-7<br>Family B ext: Sizes 1-7<br>Family C: Sizes 1-7 |
| Centralizer | Distal Centralizer Sizes 1-11…
