(258 days)
No
The summary describes software used for designing patient-specific implants based on CT scans, but it does not mention or imply the use of AI or ML algorithms for this design process or any other function of the device. The focus is on patient-specific design and instrumentation based on imaging and proprietary/off-the-shelf software, not on learning or adaptive capabilities.
Yes
The device is a hip replacement system, indicated for use in individuals undergoing total hip replacement due to severe joint pain/disability or fractures, which directly treats a medical condition.
No
The iTotal® Hip Replacement System is a patient-specific hip replacement system, including implants and instruments, used for total hip replacement surgery. It is a treatment device, not a diagnostic one. While it uses CT scan data, this is for designing the patient-specific components, not for diagnosing a condition.
No
The device description explicitly states that the system includes physical components such as femoral and acetabular components, patient specific instrumentation (iJigs), bone screws, and ancillary surgical instruments. While software is used in the design process, the device itself is a physical implant system.
Based on the provided text, the iTotal® Hip Replacement System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- iTotal® Hip Replacement System Function: The iTotal® Hip Replacement System is a surgical implant and associated instrumentation used in vivo (within the body) to replace a damaged hip joint. It is a medical device used for treatment, not for analyzing biological samples.
- Intended Use: The intended use clearly states it's for total hip replacement surgery due to various conditions affecting the hip joint. This is a surgical procedure, not a diagnostic test.
- Device Description: The description details the components of the implant (femoral and acetabular components) and surgical instruments, all of which are used during surgery.
- Image Processing: While the system uses CT scans for design, this is for planning the surgical procedure and creating patient-specific components, not for analyzing biological samples for diagnostic purposes.
Therefore, the iTotal® Hip Replacement System falls under the category of a surgical implant and instrumentation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iTotal® Hip Replacement System is designed from a patient's pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the iTotal® Hip Replacement System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
- A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
- Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision procedures for failed previous hip surgery (excluding situations where hardware is present).
The iTotal® Hip Replacement System includes standard hip replacement components as well as the following patient specific components: femoral neck, acetabular cup, single use instrumentation.
The iTotal® Hip Replacement implants are intended for cementless fixation using an anterior or posterior surgical approach.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, MEH, OQG
Device Description
The iTotal® Hip Replacement System is a patient specific hip replacement system which consists of femoral and acetabular components and patient specific instrumentation (iJigs). The femoral component consists of a standard femoral stem body with an integrated (non-modular) patient specific neck, which connects with a standard femoral head. The acetabular component consists of a metal acetabular cup with two screw holes and polyethylene liners in standard sizes. Standard bone screws and apex hole plug may also be provided with the iTotal® Hip Replacement System.
The iTotal® Hip Replacement System is intended to treat skeletally mature patients who are candidates for total hip replacement surgery.
Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific hip replacement system is designed. The iTotal® Hip Replacement System consists of the following components:
a) Femoral Component:
The femoral stem, with an integrated patient specific neck, is manufactured from titanium alloy and has a plasma sprayed hydroxyapatite (HA) coating. The femoral stem is available in various sizes. Both metal (Cobalt Chromium alloy) and Ceramic femoral heads are available for use with the iTotal® Hip Replacement System. The femoral heads are available in various sizes and offsets.
b) Acetabular Component:
The acetabular cup is manufactured from titanium alloy. The acetabular cup features a plasma sprayed outer surface. The acetabular cups are available in various sizes. The acetabular liner is manufactured from highly cross-linked Vitamin E infused ultra-high molecular weight polyethylene (iPoly® XE). The liners are available in a range of sizes with varying internal diameters and offsets. Acetabular screws and the apex hole plug are manufactured from titanium alloy.
c) Ancillary orthopedic manual surgical instruments are provided with the iTotal® Hip Replacement system to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total hip replacement components intra-operatively and in guiding the cutting/reaming of bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature individuals
Intended User / Care Setting
Not Found
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)
Non-clinical testing was conducted in accordance with applicable FDA guidance documents to confirm that the iTotal® Hip Replacement System is substantially equivalent to the predicate hip systems.
Specifically, the following testing was performed to establish substantial equivalence:
Femoral Stem Fatigue Testing
Femoral Neck Fatigue Testing
Femoral Taper-CoCr head Junction Testing
Femoral Taper-Ceramic Head Junction Testing
Acetabular Liner-Cup Disassembly Testing
Acetabular Liner Impingement Testing
Wear Testing: Adhesive and Abrasive Wear
Acetabular Bone Screw Testing
HA Coating Microstructure Characterization
HA Coating Bonding Strength (Tensile and Static Fatigue) Testing
HA Coating Shear Fatigue Testing
Range of Motion Testing
iJig Drop Testing
iJig Femoral Neck Resection Simulation
Characterization of iPoly XE
Cadaveric Evaluation
Software Verification/Validation
Bacterial Endotoxin Testing
All testing has demonstrated that the device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2017
ConforMIS, Inc. Emmanuel Nyakako Sr. Vice President, Regulatory And Quality Affairs 600 Technology Park Drive Billerica, MA 01821
Re: K162719 Trade/Device Name: iTotal® Hip Replacement System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, LZO, MEH, OQG Dated: May 15, 2017 Received: May 16, 2017
Dear Mr. Nyakako:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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) K162719
Device Name iTotal® Hip Replacement System
Indications for Use (Describe)
The iTotal® Hip Replacement System is designed from a patient's pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the iTotal® Hip Replacement System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis. or congenital hip dysplasia.
· Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
· Revision procedures for failed previous hip surgery (excluding situations where hardware is present).
The iTotal® Hip Replacement System includes standard hip replacement components as well as the following patient specific components: femoral neck, acetabular cup, single use instrumentation.
The iTotal® Hip Replacement implants are intended for cementless fixation using an anterior or posterior surgical approach.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
6.0 510(K) SUMMARY (PAGE 1 OF 5)
| Submitter's Name
and Address: | ConforMIS, Inc.
600 Technology Park Drive
Billerica, MA 01821 |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration
Number: | 3009844603 and 3004153240 |
| Date of Summary: | June 9, 2017 |
| Contact Person: | Emmanuel O. Nyakako, Sr. Vice President, Regulatory and
Quality Affairs |
| Telephone Number:
Fax Number: | (781) 345-9164
(781) 345-0147 |
| Name of the Device: | iTotal® Hip Replacement System |
| Common Name: | Total Hip Replacement System |
| Regulatory Status
and Regulation
Number:
Classification
Name: | Class II
21 CFR 888.3358
21 CFR 888.3353
Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis and
Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis. |
| Device
Classification: | Product Code:
LPH: Prosthesis, hip, semi-constrained, metal/polymer, porous
uncemented |
| | LZO: Hip joint metal/ceramic/polymer semi constrained cemented
or nonporous uncemented |
| | MEH: Prosthesis, hip, semi-constrained, uncemented,
metal/polymer, non-porous, calcium phosphate |
| | OQG: Hip Prosthesis, semi-constrained, cemented,
metal/polymer, + additive, porous, uncemented |
4
510(K) SUMMARY (PAGE 2 OF 5)
| Indications for
Use: | The iTotal® Hip Replacement System is designed from a patient's
pre-operative CT scan which must include certain necessary
anatomic landmarks that are clearly identifiable. Total hip
replacement using the iTotal® Hip Replacement System is indicated
for use in skeletally mature individuals undergoing total hip
replacement due to:
• A severely painful and/or disabled joint from osteoarthritis,
traumatic arthritis, rheumatoid arthritis, avascular necrosis,
or congenital hip dysplasia.
• Treatment of non-displaced non-unions of the hip, femoral
neck fractures, and trochanteric fractures of the proximal
femur with head involvement, unmanageable by other
techniques.
• Revision procedures for failed previous hip surgery
(excluding situations where hardware is present). | |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| | The iTotal® Hip Replacement System includes standard hip
replacement components as well as the following patient specific
components: femoral neck, acetabular cup, single use
instrumentation. | |
| | The iTotal® Hip Replacement implants are intended for
cementless fixation using an anterior or posterior surgical
approach. | |
| Identification of the
Legally Marketed
Devices (Predicate
Devices): | Pipeline Total Hip System
Device Class:
Product Code:
Regulation Number:
510(k) Number: | II
LPH, JDI, OQG, OQH
21 CFR 888.3358
K112802 |
| | Corail AMT Hip Prosthesis
Device Class:
Product Code:
Regulation Number:
510(k) Number: | II
LZO
21 CFR 888.3353
K042992 |
| | Signature Planner, Signature Guides
Device Class:
Product Code:
Regulation Number:
510(k) Number: | II
LPH, LZO, KWZ, JDI, KWY, MAY MEH
21 CFR 888.3358
K111863 |
| Identification of the
Legally Marketed
Devices (Reference
Devices): | iTotal® CR & PS Knee Replacement Systems
Device Class:
Product Code:
Regulation Number:
510(k) Number: | II
JWH, OOG, OIY
21 CFR 888.3560
K160025 & K161668 |
5
510(K) SUMMARY (PAGE 3 OF 5)
| 510(K) SUMMARY (PAGE 3 OF 5) | |
|---|---|
| Device Description: | The iTotal® Hip Replacement System is a patient specific hip |
| replacement system which consists of femoral and acetabular | |
| components and patient specific instrumentation (iJigs). The | |
| femoral component consists of a standard femoral stem body with | |
| an integrated (non-modular) patient specific neck, which connects | |
| with a standard femoral head. The acetabular component | |
| consists of a metal acetabular cup with two screw holes and | |
| polyethylene liners in standard sizes. Standard bone screws and | |
| apex hole plug may also be provided with the iTotal® Hip | |
| Replacement System. | |
| The iTotal® Hip Replacement System is intended to treat | |
| skeletally mature patients who are candidates for total hip | |
| replacement surgery. | |
| Using patient imaging (CT scan) and a combination of proprietary | |
| and off the shelf software, a patient specific hip replacement | |
| system is designed. The iTotal® Hip Replacement System | |
| consists of the following components: | |
| a) Femoral Component: | |
| The femoral stem, with an integrated patient specific | |
| neck, is manufactured from titanium alloy and has a | |
| plasma sprayed hydroxyapatite (HA) coating. The | |
| femoral stem is available in various sizes. Both metal (Cobalt Chromium alloy) and Ceramic femoral | |
| heads are available for use with the iTotal® Hip | |
| Replacement System. The femoral heads are available in | |
| various sizes and offsets. | |
| b) Acetabular Component: | |
| The acetabular cup is manufactured from titanium alloy. | |
| The acetabular cup features a plasma sprayed outer | |
| surface. The acetabular cups are available in various | |
| sizes. The acetabular liner is manufactured from highly cross- | |
| linked Vitamin E infused ultra-high molecular weight | |
| polyethylene (iPoly® XE). The liners are available in a | |
| range of sizes with varying internal diameters and offsets. Acetabular screws and the apex hole plug are | |
| manufactured from titanium alloy. | |
| c) Ancillary orthopedic manual surgical instruments are provided | |
| with the iTotal® Hip Replacement system to assist with | |
| implantation. The ancillary instruments are provided sterile | |
| and for single-use only. These patient specific instruments | |
| are provided to assist in the positioning of total hip | |
| replacement components intra-operatively and in guiding the | |
| cutting/reaming of bone. |
6
510(K) SUMMARY (PAGE 4 OF 5)
| Summary of
Technological
Characteristics: | The rationale for substantial equivalence is based on consideration
of the following device use and characteristics: | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • | Intended Use: Similar to the predicate devices, the
proposed iTotal® Hip Replacement System is intended to
be as a total hip prosthesis. |
| | • | Indications for Use: The proposed indications for use for the
iTotal® Hip Replacement System are similar to the
predicate devices as they have the same intended use. |
| | • | Operating Principle/Fundamental Technology: Similar to the
predicate devices the proposed iTotal® Hip Replacement
System is a semi-constrained, cementless artificial hip
replacement system; it consists of a femoral stem with an
integrated neck and a standard femoral head, an
acetabular cup with polyethylene liner, with optional
acetabular screws/apex holes plug, and ancillary
instrumentation. |
| | • | Materials/Coatings: The proposed iTotal® Hip Replacement
system uses the same biocompatible materials (i.e. titanium
alloy) and coatings (i.e. hydroxyapatite) as the predicate
devices |
| | • | Sterilization: Similar to the predicates, the proposed iTotal®
Hip is intended to be provided sterile (SAL 1.0x10-6) and for
single use. |
7
510(K) SUMMARY (PAGE 5 OF 5)
| Substantial
Equivalence: | The iTotal® Hip Replacement System, subject of this premarket
notification is substantially equivalent to the Pipeline Total Hip
System (K112802, cleared March 09, 2012), the Corail AMT Hip
Prosthesis (K042992, cleared February 11, 2005), and the
Signature Planner and Signature Guides (K111863, cleared June
11, 2012). Non-clinical testing was conducted in accordance with
applicable FDA guidance documents to confirm that the iTotal® Hip
Replacement System is substantially equivalent to the predicate hip
systems.
Specifically, the following testing was performed to establish
substantial equivalence:
Femoral Stem Fatigue Testing Femoral Neck Fatigue Testing Femoral Taper-CoCr head Junction Testing Femoral Taper-Ceramic Head Junction Testing Acetabular Liner-Cup Disassembly Testing Acetabular Liner Impingement Testing Wear Testing: Adhesive and Abrasive Wear Acetabular Bone Screw Testing HA Coating Microstructure Characterization HA Coating Bonding Strength (Tensile and Static Fatigue) Testing HA Coating Shear Fatigue Testing Range of Motion Testing iJig Drop Testing iJig Femoral Neck Resection Simulation Characterization of iPoly XE Cadaveric Evaluation Software Verification/Validation Bacterial Endotoxin Testing All testing has demonstrated that the device is substantially
equivalent to the predicate devices. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | Based on the testing conducted, it is concluded that the iTotal® Hip
Replacement System is substantially equivalent to the predicate
devices: The Pipeline Total Hip System (K112802, cleared March
09, 2012), Corail AMT Hip Prosthesis (K042992, cleared February
11, 2005), and Signature Planner, Signature Guides (K111863,
cleared June 15, 2012). |