HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM

K071413 · Arthrosurface, Inc. · KRR · Nov 9, 2007 · Orthopedic

Device Facts

• Record ID: K071413
• Device Name: HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM
• Applicant: Arthrosurface, Inc.
• Product Code: KRR · Orthopedic
• Decision Date: Nov 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HemiCAP™ Patello-Femoral Resurfacing Prosthesis is intended to be used in cemented arthroplasty 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.

Device Story

HemiCAP™ Patello-Femoral Resurfacing Prosthesis is a line extension of a previously cleared femoral component. Device provides increased surface area for the femoral trochlear groove, allowing greater lateral coverage and increased flexion/extension angles. System consists of a femoral component designed to mate with a fixation stud via taper interlock and an all-polyethylene patella component. Intended for cemented arthroplasty in orthopedic surgical settings. Device restores joint surface, addressing pain and dysfunction in patients with patellofemoral pathology.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological similarities to the predicate device.

Technological Characteristics

Metal/polymer semi-constrained cemented knee prosthesis. Features a femoral component designed for taper interlock with a fixation stud. Designed for increased surface area coverage of the femoral trochlear groove.

Indications for Use

Indicated for patients with osteoarthritis limited to the distal patellofemoral joint, history of patellar dislocation or fracture, or failed previous surgery (e.g., arthroscopy, tibial tubercle elevation, lateral release) 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

• HemiCAP™ Patello-Femoral Resurfacing Prosthesis (K060127)

Submission Summary (Full Text)

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K07/413

## Section 5 - 510(k) Summary = 1 - 1

| 510(k) Owner: | Arthrosurface, Inc.<br>28 Forge Parkway<br>Franklin, MA 02038<br>Tel: [phone]<br>Fax: [phone] |
|----------------------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Dawn Wilson<br>VP, Quality & Regulatory |
| Date of Preparation: | May 10, 2007 |
| Trade Name: | HemiCAP™ Patello-Femoral Resurfacing<br>Prosthesis |
| Common Name: | Knee Joint Patello-Femoral Resurfacing<br>Prosthesis |
| Device: | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
| Classification Regulation: | Regulation Number 888.3540 |
| Device Class: | Class II |
| Review Panel: | Orthopedic |
| Product Code: | KRR |

NOV 09 2007## Device Intended Use

The HemiCAP™ Patello-Femoral Resurfacing Prosthesis is intended to be used in cemented arthroplasty 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.

{1}------------------------------------------------

# Device Description

The FFL0-XXXX Patello-Femoral. Femoral Component, Large is a line extension to the Sponsor's previously cleared and commercially marketed HemiCAP™ Patello-Femoral Resurfacing Prosthesis.

This configuration is designed to allow for increased surface area of the femoral trochlear groove to provide greater coverage laterally as well as for increased flexion and extension anqles.

The proposed component is designed to mate with FFS1-XXXX Patello-Femoral Fixation Stud via taper interlock as well as the Sponsor's previously cleared and commercially marketed all-polyethylene patella component.

## Substantial Equivalency:

The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the Sponsor's previously cleared and commercially marketed device (K060127 HemiCAP™ Patello-Femoral Resurfacing Prosthesis, Arthrosurface, Inc.).

The fundamental scientific technology of the proposed device has not changed relative to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, abstract style, with bold lines forming its shape. The text is in a smaller font size and follows the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 0 9 2007

Arthrosurface, Inc. % Ms. Dawn Wilson VP, Quality & Regulatory 28 Forge Parkway Franklin, Massachusetts 02038

Re: K071413

Trade/Device Name: HemiCAP™ Patello-Femoral Resurfacing Prosthesis 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: October 3, 2007 Received: October 12, 2007

Dear Ms. Wilson:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2 - Ms. Dawn Wilson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely vours.

Sincerely yours,

Harbare Buell

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K071413

HemiCAP™ Patello-Femoral Resurfacing Prosthesis Device Name:

### Indications for Use:

The HemiCAP™ Patello-Femoral Resurfacing Prosthesis is intended to be used in cemented arthroplasty 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.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

AND/OR

| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
|------------------------------------------------|--|
|------------------------------------------------|--|

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nabaußner

Page 1 of 1

Restorative, and Neurologi

510(k) Number K071413 000014