(246 days)
No
The description focuses on the materials, design variations, and mechanical testing of a hip implant system. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to replace a hip joint to alleviate severe pain and disability caused by various medical conditions, which is a therapeutic purpose.
No
Explanation: The CoreHip® System is intended to replace a hip joint, indicating it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description explicitly states that the CoreHip System includes physical components like femoral stems manufactured from CoCrMo and Ti, which are hardware implants.
Based on the provided information, the CoreHip® System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to replace a hip joint in patients with various conditions causing severe hip pain and disability. This is a surgical procedure involving the implantation of a medical device into the body.
- Device Description: The device is described as a femoral stem made of CoCrMo or Ti, designed for cemented or uncemented fixation. These are components of a hip prosthesis, which is an implantable medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. The CoreHip® System is an implantable medical device used inside the body to replace a joint.
N/A
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LWJ, KWY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LAL testing was completed and met the pyrogen limit of 20 E.U./device.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K150062 (including K140915, K092143, K090299, K081973, K082991, K062684, K061699, K061344, K060918, K060437, and K042344)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 | Distal Centralizer | N/A | | |
5
K172235 Page 3 of 5
6
K172235 Page 4 of 5
7
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.