ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056

K053094 · Advanced Bio-Surfaces, Inc. · HSH · Feb 6, 2006 · Orthopedic

Device Facts

• Record ID: K053094
• Device Name: ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056
• Applicant: Advanced Bio-Surfaces, Inc.
• Product Code: HSH · Orthopedic
• Decision Date: Feb 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Orthoglide Medial Knee Implant is intended for use in the osteoarthritic knee, where a substantial amount of cartilage has been lost as a result of the disease. The device is indicated for uncemented use in the treatment of moderate degeneration of the medial compartment of the knee (grade II-IV chondromalacia) with no more than minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the lateral and patellofemoral compartments in patients with osteoarthritis.

Device Story

Orthoglide Medial Knee Implant is a metallic hemi-knee resurfacing prosthesis for the medial compartment. Implanted via minimally invasive surgery between the tibial plateau and femoral condyle. Device geometry and ligament tension maintain position. Functions as an articulating surface with low friction and high durability to relieve pain, improve knee alignment (valgus position), and restore joint spacing. Used by surgeons in clinical settings. Benefits include pain relief and preservation of joint function through mechanical realignment and load distribution.

Clinical Evidence

No clinical data. Evidence consists of bench testing (tensile elongation, load deflection, cyclic fatigue resistance, material consistency) and cadaver evaluations verifying surgical technique, instruments, stability, angular correction, and range of motion preservation. Biocompatibility (ISO 10993) and sterility (EN550) standards met.

Technological Characteristics

Cobalt-Chrome-Molybdenum alloy construction. Uncemented hemi-knee resurfacing prosthesis. Designed for medial compartment placement. Conforms to ISO 10993 (biocompatibility) and EN550 (sterility) standards.

Indications for Use

Indicated for patients with osteoarthritis requiring treatment for moderate medial compartment knee degeneration (grade II-IV chondromalacia), provided lateral and patellofemoral compartments show no more than minimal degeneration (grade I-II chondromalacia, no joint space loss).

Regulatory Classification

Identification

A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).

Predicate Devices

• Sulzer Orthopedics, Inc. Unicondylar Interpositional Spacer (K003269)
• ITI, Knee Interpositional Mini-Repair system (KIMRS) (K033242)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo with the text "LABS" in large, bold, sans-serif font. A trademark symbol is located to the right and slightly above the "S". Below "LABS", smaller text reads "APPLIED BIO SURFACES, INC." The text is black against a white background.

## 510(k) Summary

# Advanced Bio-Surfaces, Inc.

# Orthoglide® Medial Knee Implant

510(k) Notification K053094

## MANUFACTURER INFORMATION

- Advanced Bio-Surfaces, Inc. Name & 5909 Baker Road Address: Minnetonka, MN 55345 USA
Summary Prepared: November 2, 2005

- Contact: Philip B. Jarvi Director, Q.A. / Regulatory Affairs 952-912-5400 phone [phone] fax
## DEVICE INFORMATION

Trade Name: Orthoglide® Medial Knee Implant

Classification Name: 21CFR 888.3590 - Knec joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis

Product Code: HSH

Common / Usual Name: Hemi- knee prosthesis

Substantial equivalence: The ABS Orthoglide® Medial Knee Implant is substantially equivalent to FDA approved predicate devices with regard to indications for use, materials, technological characteristics and surgical techniques. These predicate devices

- are: Sulzer Orthopedics, Inc. Unicondylar Interpositional Spacer (K003269)
ITI, Knee Interpositional Mini-Repair system (KIMRS) (K033242)

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

Device Description: The Orthoglide Medial Knee Implant is placed in the medial compartment of the knee between the tibial plateau and femoral condyle by means of minimally invasive surgery. The instruments are intended to aid in the surgical preparation of the implant site and implant placement. The Orthoglide is made of a Cobalt-Chrome-Molybdenum Alloy. Device geometry and ligament tension combine to keep the implant in place. The implant covers the tibial plateau. The device is designed to improve the alignment of the knee, returning the joint to a more valgus position. Realignment of the knee distributes the weight-bearing forces across the joint and helps restore the normal relationships of the articular surfaces and the surrounding capsular, ligamentous and muscular structures.

The device is designed to help relieve pain by providing an articulating surface with a low coefficient of friction and high durability. Device geometry improves knee alignment and joint spacing. The device surface is smooth and when wet, is intended to mimic the lubricious surface previously provided by the articular cartilage.

- Intended Use: The Orthoglide Medial Knee Implant is intended for use in the osteoarthritic knee, where a substantial amount of cartilage has been lost as a result of the disease. The device is indicated for uncemented use in the treatment of moderate degeneration of the medial compartment of the knee (grade II-IV chondromalacia) with no more than minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the lateral and patellofemoral compartments in patients with osteoarthritis.

{2}------------------------------------------------

Substantial Equivalence: The ABS Orthoglide Medial Knee Implant is substantially equivalcnt to FDA approved predicate devices with regard to indications for use, materials, technological characteristics and surgical techniques. Orthoglide offers no additional risks to the patient and the materials and manufacturing methods add no new or additional safety concerns. The Orthoglide as well as the predicates are submitted without clinical information. The substantially equivalent predicate devices are:

Sulzer Orthopedics, Inc. Unicondylar Interpositional Spacer (K003269)

ITI, Knee Interpositional Mini-Repair system (KIMRS) (K033242)

Testing: The Orthoglide Implant has been developed, verified and validated in compliance with a comprehensive design process. The corresponding Bench Testing has been accomplished according to a Master Test Plan for the device. The test plan shows the required test, the source of the requirement, the protocol and the report. If the method is from a standard, the voluntary standard is referenced. The bench testing has demonstrated the physical attributes and durability of the Orthoglide by tensile elongation, load deflection, cyclic fatigue resistance, material consistency and stability and processing control. Cadaver testing has verified the surgical technique and instruments. Cadaver evaluations have also verified the desired physiological effects of stability, angular correction and range of motion preservation. The Orthoglide also demonstrated that it meets internationally recognized standards for

biocompatibility (ISO 10993), sterility (EN550), and conformance to material specifications. Clinical testing was not used to determine substantial equivalence.

Summary: Based on the evidence of substantial equivalence the Orthoglide is considered to safe and effective and will perform as well or better than the referenced predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

2006 FEB 6

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Philip B. Jarvi Director, Q.A./Regulatory Affairs Advanced Bio-Surfaces, Inc. 5909 Baker Road Minnetonka, Minnesota 55345

Re: K053094

Trade/Device Name: Orthoglide Medial Knee Implant Regulation Number: 21 CFR 888.3590 Regulation Name: Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis Regulatory Class: II Product Code: HSH Dated: January 19, 2006 Received: January 20, 2006

Dear Mr. Jarvi:

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

{4}------------------------------------------------

Page 2 – Mr. Philip B. Jarvi

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT rail 0077, incomig (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation on begin marketing your device as described in your Section 510(k) I mo loter witification. The FDA finding of substantial equivalence of your device to a legally premated notification - 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 11 you desire of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H Millikan

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

Enclosure

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known): K053094

Device Name: Orthoglide® Medial Knee Implant

Indications for Use:

The Orthoglide Medial Knee Implant is intended for use in the osteoarthritic knee, where substantial amounts of cartilage have been lost as a result of the disease. The device is indicated for uncemented use in the treatment of moderate degeneration of the medial compartment of the knee (grade II-IV chondromalacia) with no more than minimal degencration (grade I-II chondromalacia, no loss of joint space) in the lateral and patellofemoral compartments in patients with ostcoarthritis.

Prescription Use Yes (Part 21 CFR 801 Subpart D)

=... = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

AND/OR

Over-The-Counter Use (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)

Mark N Mulkerso

Sign-Off) Divisio: Cone Restorative Division and Neu nical bevi Page 1 of 1 S10(k) Number

(Posted November 13, 2003)