STRIDE UNICONDYLAR KNEE

K123380 · Blue Belt Technologies, Inc. · HSX · May 31, 2013 · Orthopedic

Device Facts

• Record ID: K123380
• Device Name: STRIDE UNICONDYLAR KNEE
• Applicant: Blue Belt Technologies, Inc.
• Product Code: HSX · Orthopedic
• Decision Date: May 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The STRIDE Unicondylar Knee devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. These devices are indicated for cemented use only.

Device Story

STRIDE Unicondylar Knee is a non-constrained prosthetic implant for unicompartmental knee arthroplasty. Device resurfaces one femoral condyle and one side of tibial plateau. Components include CoCrMo femoral component, titanium tibial plate, and UHMWPE insert. Device is non-constrained; stability relies on patient's native ligaments and soft tissue. Intended for cemented fixation. Used by orthopedic surgeons in clinical settings to treat joint disease, fractures, or deformities. Output is a mechanical replacement of joint surfaces to restore function and reduce pain.

Clinical Evidence

Bench testing only. Testing included Finite Element Analysis (FEA) for load stresses at various flexion angles (0-155 degrees) and varus/valgus stress, contact pressure testing per ASTM F2083-10, tibial component fatigue analysis, tibial tray/insert interlocking strength, range of motion analysis, biocompatibility per ISO 10993, and sterilization/shelf-life validation.

Technological Characteristics

Materials: CoCrMo (femoral), Titanium (tibial plate), UHMWPE (insert). Non-constrained design. Sterilization: Gamma radiation (SAL 10^-6). Packaging: Double sealed containers. Bench testing per ASTM F2083-10. No software or electronic components.

Indications for Use

Indicated for patients with painful/disabling knee joints due to osteoarthritis or traumatic arthritis, previous tibial condyle/plateau fractures with loss of anatomy/function, varus/valgus deformities, or requiring revision of previous arthroplasty. Indicated for cemented use only.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer non-constrained cemented 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 generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).

Predicate Devices

• Zimmer® Unicompartmental Knee System (K033363)
• MAKO Surgical Corporation Unicondylar Knee Implant System III (K082081)

Submission Summary (Full Text)

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Traditional 510(K) 510(K) Summary Rev 4-17-2013 STRIDE™

K123380 (1/4)

## MAY 3 1 2013

Image /page/0/Picture/4 description: The image shows a black and white logo. The logo features a central oval shape surrounded by swirling lines. The lines create a sense of motion around the oval. The overall design is abstract and modern.

# BLUE BELT TECHNOLOGIES, INC

## 510(k) Summary

510(k) SPONSOR:

Blue Belt Technologies, Incorporated 2828 Liberty Avenue, Suite 100 Pittsburgh, PA 15222

DATE 510(K) Summary was Prepared: 4-9-13

## CONTACT PERSON:

| Company Representative: | Richard Confer |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Title: | Vice President of Regulatory Affairs and Quality Assurance |
| Phone Number: | 412-860-3768 ext. 106 |
| Fax Number: | 412 683-6447 |
| E-mail address: | [e-mail] |
| TRADE NAME: | STRIDE Unicondylar Knee |
| COMMON NAME: | Unicompartmental Knee, Unicondylar Knee |
| CLASSIFICATION: | 21 CFR 888.3520 |
| CLASS: | Class II |
| PRODUCT CODE: | HSX |
| PANEL: | Orthopedic |
| PREDICATE DEVICES: | The predicate devices for the STRIDE Unicondylar Knee are the Zimmer® Unicompartmental Knee System, K033363 (cleared 1/16/2004); and the MAKO Surgical Corporation Unicondylar Knee Implant System III, K082081 (cleared 8/15/2008). |

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DEVICE DESCRIPTION: The STRIDE Unicondylar Knee device is a unicompartmental prosthetic implant that resurfaces one femoral condyle, and one side of the tibial plateau. The femoral component is made of cobalt chrome and the tibial component is. made of titanium with a UHMWPE insert that snaps into place. The device is nonconstrained; the articulating surface of the UHMWPE insert is flat and joint stability is maintained by ligaments and other soft tissue surrounding the knee.

INDICATIONS FOR USE: The STRIDE Unicondylar Knee devices are indicated for patients with:

- -Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
- Previous tibial condyle or plateau fractures with loss of anatomy or function. -
- Varus or valqus deformities. -
- Revision of previous arthroplasty procedures. -

These devices are indicated for cemented use only.

## BASIS FOR SUBSTANTIAL EQUIVALENCE:

The STRIDE Unicondylar Knee is substantially equivalent to the Zimmer Unicompartmental Knee System and the MAKO Surgical Corporation Unicondylar Knee Implant System III. All three of these devices are non-constrained unicondylar knee prostheses made of similar materials. The manufacturing and sterilization methods are equivalent. These devices are approximately the same geometrically, and indications for use are equivalent. Each of these devices is indicated for cemented use only. A comparison of the STRIDE Unicondylar Knee to the Zimmer Unicompartmental Knee and the MAKO Surgical Corporation Unicondylar Knee Implant System III indicates that the subject device is substantially equivalent to the predicate devices:

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#### Traditional 510(K) Tab 6 – 510(K) Summary Rev 2

STRIDE™

K123380 (3/4)

| Characteristics | STRIDE Unicondylar<br>Knee<br>(Subject Device) | Zimmer<br>Unicompartmental Knee<br>(ZUK) | MAKO Unicondylar Knee<br>Implant System III |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | These devices are intended<br>to be used in unicondylar<br>knee patients meeting the<br>indications for use. | These devices are intended<br>for patients with [see the<br>indications for use below]: | Mako Surgical Corp.<br>Unicondylar Knee Implant<br>System III components are<br>intended for use in<br>unicompartmental knee<br>arthroplasty as a result of<br>[see the indications for use<br>below]: |
| Indications | Painful and/or disabling knee<br>joints due to osteoarthritis or<br>traumatic arthritis. | Painful and/or disabling knee<br>joints due to osteoarthritis or<br>traumatic arthritis. | Moderately disabling joint<br>disease of the knee resulting<br>from painful osteo- or post-<br>traumatic arthritis. |
| | Previous tibial condyle or<br>plateau fractures with loss of<br>anatomy or function. | Previous tibial condyle or<br>plateau fractures with loss of<br>anatomy or function. | As an alternative to tibial<br>osteotomy in patients with<br>unicompartmental<br>Osteoarthritis. |
| | Varus or valgus deformities. | Varus or valgus deformities. | |
| | Revision of previous<br>arthroplasty procedures. | Revision of previous<br>arthroplasty procedures. | Revision of previous<br>unsuccessful<br>unicompartmental knee<br>replacement. |
| | These devices are indicated<br>for cemented use only. | These devices are indicated<br>for cemented use only. | These devices are intended<br>for cemented use only. |
| | | The ZUK unicompartmental<br>knee is designed for use<br>when load bearing ROM is<br>expected to be less than or<br>equal to 155 degrees. | |
| Materials | Femoral: CoCrMo<br>Tibial Plate: Titanium<br>Tibial Insert: UHMWPE | Femoral: CoCrMo<br>Tibial Plate: Titanium<br>Tibial Insert: UHMWPE | Femoral: CoCrMo<br>Tibial Plate: Titanium<br>Tibial Insert: UHMWPE |
| Sterilization and<br>Packaging | Gamma, metal components;<br>Gamma (UHMWPE);<br>All components are supplied<br>in double sealed containers<br>maintaining double sterile<br>barriers. Sterilization<br>parameters are designed to<br>meet SAL 10-6, and a shelf<br>life of 2 years | Gamma, metal components;<br>Gamma, (UHMWPE);<br>All components are supplied<br>in double sealed containers<br>maintaining double sterile<br>barriers | Gamma, metal components;<br>Gamma, (UHMWPE)<br>All components are supplied<br>in double sealed containers<br>maintaining double sterile<br>barriers |
| Designs | Curved back femoral<br>component, 1 posterior facet<br>Onlay tibial plate | Faceted back femoral.<br>Onlay tibial plate | Curved back femoral.<br>component, 1 posterior facet<br>Onlay and inlay tibial plates |

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Traditional 510(K) Tab 6 - 510(K) Summary Rev 2

The engineering analysis and non-clinical (bench) testing of the Stride Unicondylar Knee and the predicate included:

- Finite element analysis (FEA) comparing load stresses at 0, 15, 20, 60, 90 and . 120 and 155 degrees of flexion
- FEA Stress Analysis Comparison at .+/- 10 degrees of varus/valgus and 0, 15 ● and 60 degrees of flexion
- Contact pressure bench testing to ASTM F2083-10 for Stride .
- Engineering analysis for Stride tibial component fatique ●
- Tibial trav and insert interlocking strength and force analysis .
- Range of motion analysis .
- Biocompatibility of materials analysis per ISO 10993 .
- Sterilization to SAL of 10-6 .
- Packaging and shelf life analysis .

Analysis and testing results demonstrated that the subject device meets its design specifications.

#### SUMMARY AND CONCLUSIONS:

The STRIDE Unicondylar Knee was designed to utilize materials, geometry, and manufacturing methods similar to the predicate devices and which are currently used in clinical practice. The similarity between the subject device and the predicate devices with respect to indications, design, materials, packaging and sterilization methods, combined with FEA and bench test results, and an FMEA hazard analysis, identified no new hazards associated with the STRIDE Unicondylar Knee.

The primary differences are:

- The STRIDE Unicondylar Knee tibial plate is offered in more sizes than the . individual predicates, but covers the same ranges as the combined predicate tibial plate offering.
- . The Stride has differences in femoral component rear surface geometry than the predicate devices.

Test results and comparative performance data for the STRIDE and its predicate unicondylar implants indicate that these differences do not present any new issues of safety of effectiveness as compared to the predicates.

Therefore, based on the above analysis and data presented in this submission, a finding of substantial equivalence with the predicate devices is justified.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### May 31, 2013

Blue Belt Technologies, Incorporated % Mr. Richard Confer Vice President of Regulatory Affairs and Ouality Assurance 2828 Liberty Avenue, Suite 100 Pittsburgh, Pennsylvania 15222

Re: K123380

Trade/Device Name: Stride Unicondylar Knee System Regulation Number: 21 CFR 888:3520 Regulation Name: Knee Joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX Dated: May 21, 2013 Received: May 28, 2013

Dear Mr. Confer:

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. 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 (reporting of medical

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#### Page 2 - Mr. Richard Confer

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin I. Keith

For

| Mark N. Melkerson |
|--------------------------------|
| Director |
| Division of Orthopedic Devices |
| Office of Device Evaluation |
| Center for Devices and |
| Radiological Health |

Cinaceal - Louds

Enclosure

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510(k) Number (if known): N/A K123380

Device Name: The STRIDE Unicondylar Knee

Indications For Use:

The STRIDE Unicondylar Knee devices are indicated for patients with:

- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. -
- Previous tibial condyle or plateau fractures with loss of anatomy or function.
Previous tibial condyle or plateau fractures with loss of anatomy or function.
Varus or valgus
- Varus or valgus deformities.
- Revision of previous arthroplasty procedures.

These devices are indicated for cemented use only.

Prescription Use X Over-The-Counter Use (Part 21 CFR 801 Subpart D) AND/OR (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

Blue Belt Technologies, Inc.

10/31/2012