(211 days)
Not Found
No
The summary describes a mechanical implant and its performance testing, with no mention of AI or ML technologies.
Yes
The device is a prosthetic implant used to resurface knee joints affected by osteoarthritis, traumatic arthritis, or deformities, which are conditions that cause pain and disability, thereby providing therapeutic relief.
No
The device description indicates it is a prosthetic implant used to resurface parts of the knee, not to diagnose a condition.
No
The device description clearly states it is a "unicompartmental prosthetic implant" made of physical materials like cobalt chrome, titanium, and UHMWPE. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The STRIDE Unicondylar Knee device is a prosthetic implant that is surgically implanted into the knee joint. It is a physical device used to replace damaged parts of the knee.
- Intended Use: The intended use is to treat painful and/or disabling knee joints due to conditions like osteoarthritis or traumatic arthritis, and for revision procedures. This is a treatment for a condition, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / 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 valgus deformities.
- Revision of previous arthroplasty procedures.
These devices are indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
HSX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.
0
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: | rconfer@bluebelttech.com |
| 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). |
1
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:
2
Traditional 510(K) Tab 6 – 510(K) Summary Rev 2
STRIDE™
K123380 (3/4)
| Characteristics | STRIDE Unicondylar
Knee
(Subject Device) | Zimmer
Unicompartmental Knee
(ZUK) | MAKO Unicondylar Knee
Implant System III |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | These devices are intended
to be used in unicondylar
knee patients meeting the
indications for use. | These devices are intended
for patients with [see the
indications for use below]: | Mako Surgical Corp.
Unicondylar Knee Implant
System III components are
intended for use in
unicompartmental knee
arthroplasty as a result of
[see the indications for use
below]: |
| Indications | Painful and/or disabling knee
joints due to osteoarthritis or
traumatic arthritis. | Painful and/or disabling knee
joints due to osteoarthritis or
traumatic arthritis. | Moderately disabling joint
disease of the knee resulting
from painful osteo- or post-
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. | As an alternative to tibial
osteotomy in patients with
unicompartmental
Osteoarthritis. |
| | Varus or valgus deformities. | Varus or valgus deformities. | |
| | Revision of previous
arthroplasty procedures. | Revision of previous
arthroplasty procedures. | Revision of previous
unsuccessful
unicompartmental knee
replacement. |
| | These devices are indicated
for cemented use only. | These devices are indicated
for cemented use only. | These devices are intended
for cemented use only. |
| | | The ZUK unicompartmental
knee is designed for use
when load bearing ROM is
expected to be less than or
equal to 155 degrees. | |
| Materials | Femoral: CoCrMo
Tibial Plate: Titanium
Tibial Insert: UHMWPE | Femoral: CoCrMo
Tibial Plate: Titanium
Tibial Insert: UHMWPE | Femoral: CoCrMo
Tibial Plate: Titanium
Tibial Insert: UHMWPE |
| Sterilization and
Packaging | Gamma, metal components;
Gamma (UHMWPE);
All components are supplied
in double sealed containers
maintaining double sterile
barriers. Sterilization
parameters are designed to
meet SAL 10-6, and a shelf
life of 2 years | Gamma, metal components;
Gamma, (UHMWPE);
All components are supplied
in double sealed containers
maintaining double sterile
barriers | Gamma, metal components;
Gamma, (UHMWPE)
All components are supplied
in double sealed containers
maintaining double sterile
barriers |
| Designs | Curved back femoral
component, 1 posterior facet
Onlay tibial plate | Faceted back femoral.
Onlay tibial plate | Curved back femoral.
component, 1 posterior facet
Onlay and inlay tibial plates |
.
.
・
·
:
3
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.
4
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
5
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
6
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