Conformis BeneFIT Hip System

K190904 · Conformis, Inc. · LPH · Aug 28, 2019 · Orthopedic

Device Facts

• Record ID: K190904
• Device Name: Conformis BeneFIT Hip System
• Applicant: Conformis, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Aug 28, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

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, 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, 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 Story

BeneFIT Hip System is an uncemented, primary total hip replacement prosthesis. Components include a monoblock femoral stem with a 12/14 taper neck, femoral heads (cobalt chromium or Biolox Delta ceramic), and an acetabular shell with a polyethylene liner and cancellous screws. The system is used by orthopedic surgeons in clinical settings for total hip arthroplasty. The device is implanted via anterior or posterior surgical approaches; fixation is achieved through press-fit design and hydroxyapatite coating on the femoral stem. The acetabular liner features circumferential scallops for rotational security and orientation adjustment. By replacing damaged joint surfaces, the system aims to restore hip function, reduce pain, and improve mobility for patients with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only. Performance evaluated via femoral stem/neck fatigue testing, taper junction testing, acetabular liner-cup disassembly and impingement testing, wear testing, bone screw testing, HA coating characterization (microstructure, static/shear fatigue), and range of motion testing. Cadaveric evaluation also performed.

Technological Characteristics

Uncemented, semi-constrained hip prosthesis. Materials: Cobalt chromium alloy, Biolox Delta ceramic, polyethylene, hydroxyapatite coating. Design: Monoblock femoral stem, 12/14 taper, press-fit fixation. Acetabular component includes shell with screw holes and rotational locking liner. Sterilized.

Indications for Use

Indicated for skeletally mature individuals requiring total hip replacement due to osteoarthritis, traumatic/rheumatoid arthritis, avascular necrosis, congenital hip dysplasia, non-displaced non-unions, femoral neck/trochanteric fractures, or revision of failed prior hip surgery (excluding hardware presence).

Regulatory Classification

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.

Predicate Devices

• Conformis iTotal Hip System (K162719)
• Corail AMT Hip Prosthesis (K042992)
• Exactech Novation Crown Cup with InteGrip Acetabular Shell (K102795)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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):

| <div> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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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.<br>600 Technology Park<br>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: | [phone] | |
| Fax Number: | [phone] | |
| Name of the Device: | ConforMIS BeneFIT Hip System | |
| Common Name: | Total Hip Replacement System | |
| Regulatory Status and Regulation Number: | Class II<br>21 CFR 888.3358<br>21 CFR 888.3353 | |
| Classification Name: | Uncemented, primary total hip replacement composed of femoral and acetabular components. | |
| Device Classification: | Product Code:<br>LPH: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented<br><br>LZO: Hip joint metal/ceramic/polymer semi constrained cemented or nonporous uncemented<br><br>MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium phosphate | |
| Indications for<br>Use: | The Conformis BeneFIT Hip System is indicated for use in skeletally<br>mature individuals undergoing total hip replacement due to:<br>• A severely painful and/or disabled joint from osteoarthritis,<br>traumatic arthritis, rheumatoid arthritis, avascular necrosis, or<br>congenital hip dysplasia.<br>• Treatment of non-displaced non-unions of the hip, femoral<br>neck fractures, and trochanteric fractures of the proximal femur with<br>head involvement, unmanageable by other techniques.<br>• Revision procedures for failed previous hip surgery<br>(excluding situations where hardware is present).<br><br>The Conformis BeneFIT Hip System implants are intended for<br>cementless fixation using an anterior or posterior surgical<br>approach. | |
| Identification of<br>the Legally<br>Marketed<br>Devices<br>(Predicate<br>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 |

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# 210(K) SUMMARY (PAGE 2 OF হা

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### 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.

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## 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)<br>Description and<br>Assessment of<br>Nonclinical<br>Testing: | Nonclinical Testing: The determination of substantial equivalence for<br>this device was based on a detailed device description and non-clinical<br>laboratory testing. Testing on the Conformis BeneFIT Hip System<br>included functional testing in compliance with the applicable FDA<br>guidance documents.<br><br>Specifically, the following tests were conducted to evaluate the<br>performance of the device:<br>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. |
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| Conclusion: | Based on the testing conducted, it is concluded that the Conformis<br>BeneFIT Hip System is substantially equivalent to the predicate<br>devices: Conformis iTotal Hip Replacement System (K162719, cleared<br>June 14, 2017), the Corail AMT Hip Prosthesis (K042992, cleared<br>February 11, 2005), and the Exactech Exactech Novation Crown Cup<br>with InteGrip Acetabular ShellDevice (K102795, cleared February 2,<br>2011) |