(24 days)
Not Found
No
The summary describes patient-specific instruments and surgical plans derived from CT scans, but there is no mention of AI or ML being used in the design process. The focus is on standard hip replacement components and patient-specific instrumentation based on anatomical landmarks.
Yes
The device is a hip replacement system, indicated for total hip replacement due to various medical conditions, which inherently makes it a therapeutic device aimed at treating a health problem.
No
This device is a total hip replacement system, indicated for various hip conditions requiring joint replacement. It is a therapeutic device, not a diagnostic one. While it uses pre-operative CT scans for planning, the device itself does not diagnose medical conditions.
No
The device description explicitly states that the Cordera Hip System includes standard hip replacement components (femoral and acetabular components) which are physical implants. While it also includes patient-specific instruments and surgical plans, the core device is a hardware implant system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Cordera™ Hip System is a surgical implant used for total hip replacement. It is physically implanted into the patient's body to replace a damaged hip joint.
- Lack of Testing on Samples: The description focuses on the physical components of the hip replacement system and the use of CT scans for surgical planning and potentially patient-specific instrumentation. There is no mention of testing biological samples from the patient.
Therefore, the Cordera™ Hip System falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cordera™ Hip System may be used with iligs® designed from a patient's pre-operative CT scan, which must include certain necessary anatomic landmarks that are clearly identifiable. The Cordera™ Hip 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 Cordera™ Hip System includes standard hip replacement components, and if selected, may use patient-specific single use instrumentation.
The Conformis Cordera Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.
Product codes
LPH, LZO, OQG, MEH
Device Description
The Cordera Hip System is an uncemented, primary total hip replacement composed of femoral and acetabular components. The system can be used with or without a pre-operative CT scan that is used to design patient-specific instruments. All components are provided sterile.
The femoral component consists of a standard monoblock femoral stem body and neck, which mates with a standard femoral head. The stem and neck are manufactured as one piece and hence are not modular. The proximal neck surface with a 12/14 taper is highly polished and transitions to hydroxyapatite coating in the main stem body and is indicated for uncemented press fit fixation only. The femoral head is designed to connect to the femoral stem neck. All femoral heads are polished and have a 12/14 taper to match the femoral stem. The femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (Biolox® Delta).
The acetabular component consists of a standard size shell in 1mm increments with standard screw hole placement, a mating polyethylene liner, and cancellous screws. The acetabular component is designed for uncemented use; initial implant fixation is achieved through press-fit design. The 6.5mm diameter cancellous screws with low profile head fit through the acetabular shell screw holes and are driven using a 3.5mm hex drive recess. The acetabular component has matching circumferential scallops on the shell and liner that rotationally secure the liner in the shell and allow for dialing the liner in a desired orientation. The liner is provided with an impactor made of a biocompatible nylon material.
The purpose of this submission is to add patient specific instruments (iJigs) and surgical plans (iViews) to the Cordera Hip System.
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
Non-Clinical Performance Evaluation:
No new Cordera implants were introduced in this submission. The patient specific iJigs are made using the same design criteria, from the same materials and use the same manufacturing methods as the predicate device. Process controls are in place to ensure that the iJigs meet the performance criteria and that the risks associated with design and development of the patient specific features are mitigated.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
September 24, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
Conformis, Inc. Nancy Giezen Manager Regulatory Affairs 600 Technology Park Drive Billerica, Massachusetts 01821
Re: K202484
Trade/Device Name: Cordera Hip 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, OQG, MEH Dated: August 26, 2020 Received: August 31, 2020
Dear Nancy Giezen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vesa Vuniqi, Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202484
Device Name Cordera Hip System
Indications for Use (Describe)
The Cordera™ Hip System may be used with iligs® designed from a patient's pre-operative CT scan, which must include certain necessary anatomic landmarks that are clearly identifiable. The Cordera™ Hip 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 Cordera™ Hip System includes standard hip replacement components, and if selected, may use patient-specific single use instrumentation.
The Conformis Cordera Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
| Submitter's Name and Address: | Conformis, Inc.
600 Technology Park Drive
Billerica, MA 01821 |
|---------------------------------------|-----------------------------------------------------------------------|
| Establishment Registration Number(s): | 3009844603 and 3004153240 |
| Date Summary was Prepared: | August 25th, 2020 |
| Contact Person: | Nancy Giezen
Manager Regulatory Affairs
Telephone: 781-345-9058 |
Trade/Device Name(s): Conformis Hip System
Conformis Hip System
Common Name: Hip Replacement System
Device Class:
Class II
Regulation Numbers: 21 CFR 888.3353, 21 CFR 888.3358
Classification Names and Product Codes:
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (LZO, MEH) Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis (LPH, OQG)
Legally Marketed Predicate Device (Primary Predicate): BeneFIT Hip System (K190904)
(Secondary Predicates): Conformis Hip System (K162719, K192198)
4
Device Description:
The Cordera Hip System is an uncemented, primary total hip replacement composed of femoral and acetabular components. The system can be used with or without a pre-operative CT scan that is used to design patient-specific instruments. All components are provided sterile.
The femoral component consists of a standard monoblock femoral stem body and neck, which mates with a standard femoral head. The stem and neck are manufactured as one piece and hence are not modular. The proximal neck surface with a 12/14 taper is highly polished and transitions to hydroxyapatite coating in the main stem body and is indicated for uncemented press fit fixation only. The femoral head is designed to connect to the femoral stem neck. All femoral heads are polished and have a 12/14 taper to match the femoral stem. The femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (Biolox® Delta).
The acetabular component consists of a standard size shell in 1mm increments with standard screw hole placement, a mating polyethylene liner, and cancellous screws. The acetabular component is designed for uncemented use; initial implant fixation is achieved through press-fit design. The 6.5mm diameter cancellous screws with low profile head fit through the acetabular shell screw holes and are driven using a 3.5mm hex drive recess. The acetabular component has matching circumferential scallops on the shell and liner that rotationally secure the liner in the shell and allow for dialing the liner in a desired orientation. The liner is provided with an impactor made of a biocompatible nylon material.
The purpose of this submission is to add patient specific instruments (iJigs) and surgical plans (iViews) to the Cordera Hip System.
Indications for Use:
The Cordera™ Hip System may be used with iJigs® designed from a patient's pre-operative CT scan, which must include certain necessary anatomic landmarks that are clearly identifiable. The Cordera™ Hip 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 Cordera™ Hip System includes standard hip replacement components, and if selected, may use patient-specific single use instrumentation.
The Conformis Cordera Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.
5
Technological Characteristics:
The subject devices incorporate components with materials and designs consistent with previously cleared devices. The operating principle, fundamental technology, manufacturing methods and sterilization options are the same as the predicates.
Non-Clinical Performance Evaluation:
No new Cordera implants were introduced in this submission. The patient specific iJigs are made using the same design criteria, from the same materials and use the same manufacturing methods as the predicate device. Process controls are in place to ensure that the iJigs meet the performance criteria and that the risks associated with design and development of the patient specific features are mitigated.
Conclusion:
Based on a comparison of the intended use and technological characteristics to predicate devices the Cordera Hip System is considered substantially equivalent to the predicates.