Episealer Patellofemoral System

K221048 · Episurf Medical, Inc. · KRR · Dec 23, 2022 · Orthopedic

Device Facts

• Record ID: K221048
• Device Name: Episealer Patellofemoral System
• Applicant: Episurf Medical, Inc.
• Product Code: KRR · Orthopedic
• Decision Date: Dec 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Episealer Patellofemoral System is intended to be used in patients with osteoarthritis limited to the distal patellofemoral joint, patients with a history of patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists. The device is intended for cemented fixation.

Device Story

Patient-individualized arthroplasty system for patellofemoral joint replacement; consists of Episealer PF (trochlear implant) and Patellar Component. Implanted via cemented fixation. Used in clinical orthopedic settings by surgeons to address joint damage; restores articulation between distal femur and patella. Benefits patients by alleviating pain and correcting dysfunction associated with osteoarthritis or failed prior surgeries.

Clinical Evidence

Bench testing included wear testing, contact area analysis, and cantilever bending strength testing. A cadaver study was conducted to validate the accuracy of component placement relative to pre-planned positions, including recession and engagement of the Episealer PF and Patellar components.

Technological Characteristics

Patient-individualized metal/polymer semi-constrained cemented prosthesis. Components: Episealer PF (femoral) and Patellar component. Fixation: Cemented.

Indications for Use

Indicated for patients with distal patellofemoral joint osteoarthritis, history of patellar fracture, or failed prior surgical interventions (e.g., arthroscopy, tibial tubercle elevation, lateral release) presenting with persistent pain, deformity, or dysfunction.

Regulatory Classification

Identification

A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. 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 includes a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” (vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and (viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and (viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”

Predicate Devices

• Arthrosurface Patello-Femoral Arthroplasty System (K060127)

Reference Devices

• Arthrosurface Patello-Femoral Arthroplasty System (K181280)
• Arthrosurface Patello-Femoral Arthroplasty System (K071413)
• Restoris Multi Compartmental Knee (MCK) (K172326)

Submission Summary (Full Text)

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December 23, 2022

Episurf Medical, Inc. % Hollace Rhodes Vice President, Orthopedic Regulatory Affairs Mcra, LLC 803 7th St NW Washington, District of Columbia 20001

Re: K221048

Trade/Device Name: Episealer® Patellofemoral System Regulation Number: 21 CFR 888.3540 Regulation Name: Knee Joint Patellofemoral Polymer/Metal Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRR Dated: December 1, 2022 Received: December 1, 2022

Dear Hollace Rhodes:

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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Ting Song -S

Ting Song, Ph.D. 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) K221048

Device Name

Episealer Patellofemoral System

#### Indications for Use (Describe)

The Episealer Patellofemoral System is intended to be used in patients with osteoarthritis limited to the distal patellofemoral joint, patients with a history of patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

The device is intended for cemented fixation.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

| Device Trade Name: | Episealer® Patellofemoral System |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Episurf Operations, AB<br>Karlavägen 60<br>SE-114 49 Stockholm<br>Sweden |
| Contact: | Ms. Hollace Saas Rhodes<br>Vice President, Orthopedic Regulatory Affairs<br>MCRA, LLC<br>803 7th Street, NW, 3rd Floor<br>Washington, DC 20001<br>Direct: [phone]<br>Mobile: [phone]<br>[e-mail] |
| Prepared by: | MCRA, LLC<br>803 7th Street, NW, 3rd Floor<br>Washington, DC 20001<br>Office: 202.552.5800 |
| Date Prepared: | December 23, 2022 |
| Regulation: | 21 CFR 888.3540, Knee Joint Patellofemoral Polymer/Metal<br>Semi-Constrained Cemented Prosthesis |
| Class: | II |
| Product Code: | KRR |
| Primary Predicate: | Arthrosurface Patello-Femoral Arthroplasty System (K060127) |
| Reference Devices: | Arthrosurface Patello-Femoral Arthroplasty System (K181280,<br>K071413)<br>Restoris Multi Compartmental Knee (MCK) (K172326) |

#### Indications For Use:

The Episealer Patellofemoral System is intended to be used in patients with osteoarthritis limited to the distal patellofemoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

The device is intended for cemented fixation.

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### Device Description:

The Episealer Patellofemoral System is a patient-individualized arthroplasty device which replaces a damaged patellofemoral joint. The subject device consists of two components:

- . Episealer PF
- Patellar Component ●

The Episealer PF component is implanted centrally in the trochlear area of the distal femur. The Patellar Component is implanted on the backside of the patella and articulates with the Episealer PF.

## Predicate and Reference Devices:

Predicate: Arthrosurface Patello-Femoral Arthroplasty System (K060127)

Reference Devices: Arthrosurface Patello-Femoral Arthroplasty System (K181280, K071413), and Restoris Multi Compartmental Knee (MCK) (K172326)

### Performance Testing Summary:

Wear testing of the Episealer Patellofemoral System was performed. In addition, analyses of contact area and cantilever bending strength were conducted.

A cadaver study was conducted to demonstrate that the components of the patient-matched Episealer Patellofemoral System can be accurately placed relative to the pre-planned position, with proper recession and engagement of the Episealer PF and Patellar components.

The testing, engineering analyses, and cadaver study demonstrate the ability of the Episealer Patellofemoral System to perform as intended in the target population.

## Substantial Equivalence:

The Episealer Patellofemoral System is equivalent to the predicate device, the Arthrosurface Patello-Femoral Arthroplasty System, with respect to intended use, materials, geometry, range of sizes, and method of fixation. Therefore, the substantial equivalence between these two devices has been established.