K Number
K190904
Device Name
Conformis BeneFIT Hip System
Manufacturer
Date Cleared
2019-08-28

(142 days)

Product Code
Regulation Number
888.3358
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ConforMIS BeneFIT 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, 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, manageable by other techniques. - Revision procedures for failed previous hip surgery (excluding situations where hardware is present). . The ConforMS BeneFIT Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.
Device Description
The Conformis BeneFIT Hip System is an uncemented, primary total hip replacement composed of femoral and acetabular components. 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 fits through the acetabular shell screw holes and is 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.
More Information

Not Found

No
The description focuses on the mechanical components and materials of the hip replacement system. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.

Yes
The device is a hip replacement system, used to treat severely painful and/or disabled joints, which directly alleviates pain and restores function.

No

The device is a total hip replacement system, indicated for surgical implantation to treat joint issues, not to diagnose them.

No

The device description clearly details physical components (femoral and acetabular components, screws, liner, impactor) made of materials like cobalt chromium alloy, ceramic, and polyethylene. The performance studies also focus on testing these physical components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Description: The ConforMIS BeneFIT Hip System is a physical implant (femoral and acetabular components) used in total hip replacement surgery. It is surgically implanted into the patient's body.
  • Intended Use: The intended use is to replace a damaged hip joint due to various conditions. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.

The description clearly indicates a medical device used for surgical treatment, not for diagnosing a condition using in vitro methods.

N/A

Intended Use / Indications for Use

The ConforMIS BeneFIT 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, 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, manageable by other techniques.
  • Revision procedures for failed previous hip surgery (excluding situations where hardware is present). . The ConforMS BeneFIT Hip System 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 Conformis BeneFIT Hip System is an uncemented, primary total hip replacement composed of femoral and acetabular components. 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 fits through the acetabular shell screw holes and is 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

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)

Nonclinical Testing: The determination of substantial equivalence for this device was based on a detailed device description and non-clinical laboratory testing. Testing on the Conformis BeneFIT Hip System included functional testing in compliance with the applicable FDA guidance documents. Specifically, the following tests were conducted to evaluate the performance of the device: 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, Acetabular Bone Screw Testing, HA Coating Microstructure Characterization, HA Coating Static Fatigue Testing, HA Coating Shear Fatigue, Range of Motion Testing, Chemical and Mechanical Characterization of iPoly XE, Cadaveric Evaluation. Test results demonstrated that the device can be considered substantially equivalent to the predicate devices for the specified intended use.

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.

K162719, K042992, K102795

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.

Not Found

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

August 28, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and 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.

ConforMIS, Inc. Emmanuel Nyakako Sr. Vice President, Regulatory and Quality Affairs 600 Technology Park Billerica, Massachusetts 01821

Re: K190904

Trade/Device Name: Conformis BeneFIT 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, MEH, OQG Dated: July 29, 2019 Received: July 30, 2019

Dear Emmanuel 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

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.

FOR Vesa Vuniqi Acting 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) K190904

Device Name ConforMIS, Inc. BeneFIT Hip System

Indications for Use (Describe)

The ConforMIS BeneFIT 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, 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, manageable by other techniques.
  • Revision procedures for failed previous hip surgery (excluding situations where hardware is present). . The ConforMS BeneFIT Hip System 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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6.0 510(K) SUMMARY (PAGE 1 OF 5)

510(K) SUMMARY (PAGE 1 OF 5)
Submitter's Name and Address:ConforMIS, Inc.
600 Technology Park
Billerica, MA 01821
Establishment Registration Number:3009844603 and 3004153240
Date of Summary:July 29, 2019
Contact Person:Emmanuel Nyakako, Sr. Vice President, Regulatory and Quality Affairs
Telephone Number:(781) 345-9164
Fax Number:(781) 583-5006
Name of the Device:ConforMIS BeneFIT Hip System
Common Name:Total Hip Replacement System
Regulatory Status and Regulation Number:Class II
21 CFR 888.3358
21 CFR 888.3353
Classification Name:Uncemented, primary total hip replacement composed of femoral and acetabular components.
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 | |
| Indications for
Use: | The Conformis BeneFIT 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 Conformis BeneFIT Hip System implants are intended for
cementless fixation using an anterior or posterior surgical
approach. | |
| Identification of
the Legally
Marketed
Devices
(Predicate
Devices): | Primary Predicate: | |
| | Conformis iTotal Hip System | |
| | Device Class: | II |
| | Product Code: | LPH, JDI, OQG, OQH |
| | Regulation Number: | 21 CFR 888.3358 |
| | 510(k) Number: | K162719 |
| | Secondary Predicates: | |
| | Corail AMT Hip Prosthesis | |
| | Device Class: | II |
| | Product Code: | LZO |
| | Regulation Number: | 21 CFR 888.3353 |
| | 510(k) Number: | K042992 |
| | Exactech Novation Crown Cup with InteGrip Acetabular ShellDevice | |
| | Class: | II |
| | Product Code: | |
| | Regulation Number: | 21 CFR 888.3353 |
| | 510(k) Number: | K102795 |

4

210(K) SUMMARY (PAGE 2 OF হা

5

510(K) SUMMARY (PAGE 3 OF 5)

The Conformis BeneFIT Hip System is an uncemented, primary total Device hip replacement composed of femoral and acetabular components. Description: 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 fits through the acetabular shell screw holes and is 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.

6

510(K) SUMMARY (PAGE 4 OF 5)

The Conformis BeneFIT Hip System, subject of this premarket Substantial notification is substantially equivalent to the Conformis iTotal Hip Equivalence: Replacement System (K162719, cleared June 14, 2017), the Corail AMT Hip Prosthesis (K042992, cleared February 11, 2005), and the Exactech Exactech Novation Crown Cup with InteGrip Acetabular ShellDevice (K102795, cleared February 2, 2011). Non-clinical testing was conducted in accordance with applicable FDA guidance documents to confirm that the Conformis BeneFIT Hip System is substantially equivalent to the predicate hip systems.

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510(K) SUMMARY (PAGE 5 OF 5)

| 510(K) SUMMARY (PAGE 5 OF 5)
Description and
Assessment of
Nonclinical
Testing: | Nonclinical Testing: The determination of substantial equivalence for
this device was based on a detailed device description and non-clinical
laboratory testing. Testing on the Conformis BeneFIT Hip System
included functional testing in compliance with the applicable FDA
guidance documents.

Specifically, the following tests were conducted to evaluate the
performance of the device:
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 Acetabular Bone Screw Testing HA Coating Microstructure Characterization HA Coating Static Fatigue Testing HA Coating Shear Fatigue Range of Motion Testing Chemical and Mechanical Characterization of iPoly XE Cadaveric Evaluation Test results demonstrated that the device can be considered substantially equivalent to the predicate devices for the specified intended use. |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | Based on the testing conducted, it is concluded that the Conformis
BeneFIT Hip System is substantially equivalent to the predicate
devices: Conformis iTotal Hip Replacement System (K162719, cleared
June 14, 2017), the Corail AMT Hip Prosthesis (K042992, cleared
February 11, 2005), and the Exactech Exactech Novation Crown Cup
with InteGrip Acetabular ShellDevice (K102795, cleared February 2,
2011) |