(27 days)
No
The summary describes a patient-specific hip replacement system based on CT scans and patient-specific surgical guides (iJigs) and plans (iViews). While this involves processing medical imaging data to create customized devices and guides, there is no mention of AI, ML, deep learning, or any related terms in the provided text. The process appears to be based on traditional image processing and design techniques for patient-specific implants and instrumentation.
Yes
The device is a total hip replacement system, which is used to treat severe pain and/or disability caused by various conditions, thus directly addressing and alleviating a medical condition.
No
This device is a total hip replacement system, primarily composed of implants and surgical instruments. It is used for treatment, not for diagnosing medical conditions.
No
The device description explicitly states that the ACTERA™ hip system is comprised of physical components, including femoral and acetabular implants, reusable instruments, and disposable iJigs. While it utilizes preoperative CT scans and potentially surgical plans (iViews), the core of the device is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ACTERA™ hip system is for total hip replacement surgery in skeletally mature individuals due to various hip conditions. This is a surgical implant, not a diagnostic test performed on biological samples.
- Device Description: The device is described as an uncemented, primary total hip replacement system comprised of femoral and acetabular components, along with surgical instruments. This aligns with a surgical implant and associated tools.
- No mention of in vitro testing: The text does not describe any process of testing biological samples (blood, tissue, etc.) outside of the body to diagnose a condition or monitor a patient's health.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The ACTERA™ hip system is a therapeutic device used to replace a damaged hip joint.
N/A
Intended Use / Indications for Use
The ACTERA™ hip system may be designed from a patient's preoperative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the ACTERA™ hip system is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
-
A severely painful and/or disabled joint from osteoarthrits, 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 ACTERA™ hip system implants are intended for cementless fixation using an anterior, lateral or posterior surgical technique.
Product codes (comma separated list FDA assigned to the subject device)
MEH, OOG
Device Description
The ACTERA™ hip system is an uncemented, primary total hip replacement system comprised of femoral and acetabular components. All implanted components are provided sterile. Optional Surgical plans (iViews) and iJgs/ancillary instruments are also available. Non-sterile reusable instruments are provided.
The subject ACTERA™ is comprised of the subject Actera™ femoral stem (cleared in K221104) with additional sizes (0, 1 and 10, 11, 12) added to the size portfolio. Additionally, the subject ACTERA™ will offer a patient specific neck option. This option has the same stem body (K221104) with a patient specific neck (K192198). The patient specific neck has the same neck version angle, and similar neck length as that cleared in the secondary predicate Conformis Hip System (K192198). The subject hip stems with patient specific necks are compatible with the same femoral heads and acetabular components as the patient specific necks cleared in the Conformis Hip System (K192198). The ACTERA™ with the patient-specific neck option will be ordered as 'ACTERA™ HipRx'.
This submission also seeks clearance of iJigs®/Ancillary Instruments to assist in the positioning of the ACTERA™ implants. The iJigs® are sterile, single-use disposable instruments of nylon material. These instruments may be standardized or patient specific. These instruments are the iJig instrumentation described in the secondary predicate K192198 (and K202484). These instruments were not offered with the initial release of the ACTERA™ device, primary predicate Actera™ K221104. Additionally, Surgical Plans, called iViews, are also part of this submission. The iJigs and iViews are provided based on ordered options.
The stem taper is identical to the predicates. The subject device, ACTERA™ is compatible with the previously cleared femoral heads (Ceramic or CoCrMo) and acetabular components. The femoral head is unchanged from the previously cleared predicate Conformis Cordera Hip system (K202484). The Cordera acetabular cup, Cordera cup liner and Cordera screws are unchanged from the previously cleared predicate Conformis Cordera Hip system (K202484). There are no changes with this these components and are not the subject of this submission.
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)
Performance testing included ISO 7206-6 stem neck fatigue testing and ISO 7206-4 distal stem fatigue testing. Tensile Testing, Static Shear Stress Testing, Shear Fatigue Testing and coating microstructure characterization were previously performed. Verification and validation studies were also conducted. The results of the testing support that the subject device is as safe and as effective as the predicate devices. No new issues of safety or efficacy were raised.
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
§ 888.3353 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 & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 23, 2023
Conformis Inc Mary Kruitwagen Sr. Regulatory Affairs Specialist 600 Technology Park Dr Fourth Floor Billerica, Massachusetts 01821
Re: K231178
Trade/Device Name: ActeraTM hip 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: MEH, OOG Dated: April 24, 2023 Received: April 26, 2023
Dear Mary Kruitwagen:
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.
1
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) 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 mediation-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.
Limin Sun -S
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231178
Device Name
ACTERATM hip system
Indications for Use (Describe)
The ACTERA™ hip system may be designed from a patient's preoperative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the ACTERA™ hip system is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
-
A severely painful and/or disabled joint from osteoarthrits, 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 ACTERA™ hip system implants are intended for cementless fixation using an anterior, lateral or posterior surgical technique.
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for Conformis. The logo consists of a stylized letter "C" in orange and black, with the word "CONFORMIS" written in black and orange to the right of the "C". The "FORMIS" portion of the word is in orange, while the "CON" portion is in black.
510(k) SUMMARY
| Submitter's Name and Address: | Conformis, Inc.
600 Technology Park Drive,
Fourth Floor
Billerica, MA 01821
USA |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number(s): | 3009844603 and 3004153240 |
| Date Summary was Prepared: | May 15, 2023 |
| Contact Person:
Contact Information: | Mary Kruitwagen
Sr. Regulatory Affairs Specialist
Mary.Kruitwagen@conformis.com
781-345-9038 |
| Trade/Device Name(s) Device 1
Common Name:
Device Class: | ACTERA™ hip system
Total Hip Replacement System
Class 2 |
| Regulation Number(s) and
Classification Names | 21 CFR 888.3353 - Hip joint metal/polymer/metal semi-constrained
porous-coated uncemented prosthesis |
| | 21 CFR 888.3358 - Hip joint metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis |
| Product Codes: | Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-
porous, calcium phosphate (MEH) |
| | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, +
Additive, Porous, Uncemented (OQG) |
| Primary Predicate Device: | K221104 Actera Hip System |
| Secondary Predicate Device: | K192198 Conformis Hip System (Rebranded Cordera HipRx) |
Device Description:
The ACTERA™ hip system is an uncemented, primary total hip replacement system comprised of femoral and acetabular components. All implanted components are provided sterile. Optional Surgical plans (iViews) and iJgs/ancillary instruments are also available. Non-sterile reusable instruments are provided.
4
Image /page/4/Picture/0 description: The image contains the logo for Conformis. The logo consists of a stylized letter "C" in orange and black, positioned above the company name "CONFORMIS." The letters "CON" are in black, while "FORMIS" is in orange, matching the color scheme of the "C" symbol above.
The subject ACTERA™ is comprised of the subject Actera™ femoral stem (cleared in K221104) with additional sizes (0, 1 and 10, 11, 12) added to the size portfolio. Additionally, the subject ACTERA™ will offer a patient specific neck option. This option has the same stem body (K221104) with a patient specific neck (K192198). The patient specific neck has the same neck version angle, and similar neck length as that cleared in the secondary predicate Conformis Hip System (K192198). The subject hip stems with patient specific necks are compatible with the same femoral heads and acetabular components as the patient specific necks cleared in the Conformis Hip System (K192198). The ACTERA™ with the patient-specific neck option will be ordered as 'ACTERA™ HipRx'.
This submission also seeks clearance of iJigs®/Ancillary Instruments to assist in the positioning of the ACTERA™ implants. The iligs® are sterile, single-use disposable instruments of nylon material. These instruments may be standardized or patient specific. These instruments are the iJig instrumentation described in the secondary predicate K192198 (and K202484). These instruments were not offered with the initial release of the ACTERA™ device, primary predicate Actera™ K221104. Additionally, Surgical Plans, called iViews, are also part of this submission. The iligs and iViews are provided based on ordered options.
The stem taper is identical to the predicates. The subject device, ACTERA™ is compatible with the previously cleared femoral heads (Ceramic or CoCrMo) and acetabular components. The femoral head is unchanged from the previously cleared predicate Conformis Cordera Hip system (K202484). The Cordera acetabular cup, Cordera cup liner and Cordera screws are unchanged from the previously cleared predicate Conformis Cordera Hip system (K202484). There are no changes with this these components and are not the subject of this submission.
The purpose of this submission is to seek clearance of the subject ACTERA™ femoral stems (expanded sizes and patient specific neck option), iJigs and surgical plans, which are substantially equivalent to the cleared primary and secondary predicate devices.
Indications for Use:
The ACTERA™ hip system may be designed from a patient's preoperative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the ACTERA™ 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, rheumatic 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 ACTERA™ hip system implants are intended for cementless fixation using an anterior, lateral or posterior surgical technique.
Technological Characteristics:
The subject ACTERA™ femoral stem extends the size portfolio to 0-12 and the ACTERA™ HipRx is the previously cleared ACTERA stem body with a patient specific neck. Both stems are compatible with the previously cleared femoral heads and acetabular components. The iligs are similar to those of the
5
Image /page/5/Picture/0 description: The image shows the logo for Conformis. The logo consists of a stylized letter "C" in orange and black, with the word "CONFORMIS" written below it. The first four letters of the word are in black, and the last three letters are in orange.
secondary predicate device. The subject devices incorporate components with materials and designs that are the same as the previously cleared predicate devices. The operating principle, fundamental technology, materials, manufacturing methods and sterilization options are the primary predicate device.
Non-Clinical Performance Evaluation:
The ACTERA™ femoral stem (with extended sizes and with the patient specific neck option), iView and iligs are introduced in this submission. Performance testing includes ISO 7206-6 stem neck fatigue testing and ISO 7206-4 distal stem fatigue testing. Tensile Testing, Static Shear Stress Testing, Shear Fatigue Testing and coating microstructure characterization were previously performed. Verification and validation studies were also conducted. The results of the testing support that the subject device is as safe and as effective as the predicate devices. No new issues of safety or efficacy were raised.
Conclusion:
Based on a comparison of the intended use and technological characteristics of the subject devices to predicate devices, and the results of the confirmatory testing, it is concluded that the proposed ACTERA™ hips system is considered substantially equivalent.