(256 days)
Not Found
No
The description focuses on the mechanical design and materials of a joint implant, with no mention of AI or ML capabilities.
Yes
The device is intended to treat conditions like rheumatoid arthritis, traumatic arthritis, and osteoarthritis by replacing a damaged joint, thereby restoring function and alleviating pain. This direct intervention for a medical condition classifies it as a therapeutic device.
No
The device description clearly states "The Skeletal Dynamics Stablyx CMC Arthroplasty Implant Set is intended to replace the proximal end of the first metacarpal..." This indicates it's an implant for treatment, not for diagnosis.
No
The device description clearly indicates it is a physical implant made of Cobalt Chrome with a Titanium Plasma Spray coating, intended for surgical implantation. It also includes system-specific instrumentation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The Stablyx CMC Arthroplasty Implant Set is a surgical implant designed to replace a joint in the hand. It is a physical device implanted into the body.
- Intended Use: The intended use is to replace a damaged joint, not to perform a diagnostic test on a biological sample.
The description clearly indicates a surgical implant for treatment, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Skeletal Dynamics Stablyx CMC Arthroplasty Implant Set is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb or a thumb with limited range of motion. This implant is intended for uncemented, press fit use.
Product codes (comma separated list FDA assigned to the subject device)
KYI
Device Description
The Stablyx CMC Arthroplasty System is a hemi monoblock prosthesis for replacement of the first metacarpal carpometacarpal (CMC) joint. The single piece prosthesis has a highly polished, saddle shaped (toroidal) articular surface which mirrors the normal anatomy of the base of the first metacarpal. The saddle surface of the Stablyx CMC prosthesis articulates against the saddle surface of the trapezium, allowing for flexionextension, abduction-adduction and opposition motions.
The prosthesis is available in five sizes, and is made of Cobalt Chrome (CoCr) with a Titanium Plasma Spray (TPS) coated stem which may assist in biological fixation. The stem is intended to press fit into the medullary canal. Each prosthesis is packaged and provided sterile.
The Stablyx CMC Arthroplasty System is comprised of:
- Multiple sized hemi ioint prosthesis .
- System specific instrumentation .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first metacarpal carpometacarpal (CMC) joint, proximal end of the first metacarpal
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)
Engineering analysis and cadaveric testing demonstrated that the Stablyx CMC Arthrodesis Implant Set is substantially equivalent to devices currently marketed. Therefore, the subject device is as safe and effective as legally marketed predicate devices.
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
§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.
(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the text "KIII068" on the left side of the image. To the right of this text is the fraction "1/2". The text and fraction are written in black ink on a white background. The handwriting appears to be casual and informal.
DEC 3 0 2011
Image /page/0/Picture/2 description: The image shows the logo for Skeletal Dynamics. The logo consists of a stylized four-petal flower-like symbol on the left, followed by the words "skeletal dynamics" on the right. The word "skeletal" is on the first line, and the word "dynamics" is on the second line.
510(k) Summary of Safety and Effectiveness Skeletal Dynamics Stablyx CMC Arthroplasty Implant Set
April 14, 2011
Submitter:
Skeletal Dynamics, LLC 8905 SW 87 Avenue Suite 102 Miami, FL 33176 Tel: (305) 596-7585 Fax: (305) 596-7591 Contact: Ana M. Escagedo, Vice President Email: aescagedo@skeletaldynamics.com
Establishment Registration Number: 3006742481
Trade Name, Common Name. Classification:
Trade Name Stablyx CMC Arthroplasty Implant Set Common Name Prosthesis, wrist, carpal trapezium 21 CFR §888.3770 Classification Product Code KYI Class II Class
Predicate Devices:
Ascension, PyroCarbon Saddle CMC (K061451) BioPro Modular Thumb Implant (K052596)
Description of the Device:
The Stablyx CMC Arthroplasty System is a hemi monoblock prosthesis for replacement of the first metacarpal carpometacarpal (CMC) joint. The single piece prosthesis has a highly polished, saddle shaped (toroidal) articular surface which mirrors the normal anatomy of the base of the first metacarpal. The saddle surface of the Stablyx CMC prosthesis articulates against the saddle surface of the trapezium, allowing for flexionextension, abduction-adduction and opposition motions.
The prosthesis is available in five sizes, and is made of Cobalt Chrome (CoCr) with a Titanium Plasma Spray (TPS) coated stem which may assist in biological fixation. The stem is intended to press fit into the medullary canal. Each prosthesis is packaged and provided sterile.
The Stablyx CMC Arthroplasty System is comprised of:
- Multiple sized hemi ioint prosthesis .
- System specific instrumentation .
1
Intended Use:
The Skeletal Dynamics Stablyx CMC Arthroplasty Implant set is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This implant is intended for uncemented, press fit use.
Summary of Technological Characteristics / Substantial Equivalence:
The substantial equivalence of the Skeletal Dynamics Stablyx CMC Arthrodesis Implant Set to the predicate devices is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging, and does not present any new issues of safety or effectiveness.
Performance Testing:
Engineering analysis and cadaveric testing demonstrated that the Stablyx CMC Arthrodesis Implant Set is substantially equivalent to devices currently marketed. Therefore, the subject device is as safe and effective as legally marketed predicate devices.
Conclusion:
The Skeletal Dynamics Stablyx CMC Arthrodesis Implant Set is substantially equivalent to the predicate devices identified in this premarket notification.
KIIIDPA
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tails, representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
DEC 3 0 2011
Skeletal Dynamics, Inc. % Ms. Ana Escagedo 8905 SW 87th Avenue Suite 201 Miami, Florida 33176
Re: K111068
Trade/Device Name: Stablyx CMC Arthroplasty System Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: KYI Dated: December 10, 2011 Received: December 12, 2011
Dear Ms. Escagedo:
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
3
Page 2 - Ms. Ana Escagedo
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): )( \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \
Device Name: Stablyx CMC Arthroplasty Implant Set
Indications For Use:
The Skeletal Dynamics Stablyx CMC Arthroplasty Implant Set is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb or a thumb with limited range of motion. This implant is intended for uncemented, press fit use.
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. Thuner
Sign-Oft) (Divis . >f Surgical, Orthopedic, Divisi . and Nesprative Devices
Page 1 of 1
K11068 510(k) Number.